Wolfgang Wodarg , former SPD member of parliament, and chairman of the European parliament’s health committee, initiated the inquiry. The motion was passed unanimously by his colleagues in the European parliament‘s health committee.
Wodarg has criticised the measures taken against the swine flu as "one of the biggest medical scandals of the century.“
He said the influence of the the pharmaceutical industry on scientists and government officials has resulted in "millions of healthy people being exposed unnecessarily to the risks of an inadequately tested vaccine.“ That even though the swine flu virus is "much less harmful“ than last year’s seasonal flu, causing "not even a tenth of the usual deaths associated with flu.“
Wodarg has also criticised the way pharmaceutical companies have made gigantic profits at the expense of taxpayers.
He accused vaccine manufacturers of being willing even to inflict bodily harm in their pursuit of profits, noting that the adjuvants in the swine flu jab have hardly been tested. In addtion,the vaccine‘s side effects including dangerous paralysis have not been adequately recorded.
Wodarg has said that the role of the WHO and its pandemic emergency declaration in June needs to be the special focus of a European parliamentary inquiry. For the first time the criteria for a pandemic was made not the actual risk of a disease, but the number of cases of the disease.
By classifying the swine flu as pandemic, nations were compelled to implement pandemic plans and also to purchase swine flu vaccines.
Because WHO is not subject to any parliamentary control, Wodarg argued it is necessary for governments to insist on accountability.
21 Mayıs 2010 Cuma
EUROPEAN PARLIAMENT TO INVESTIGATE WHO IN JANUARY 2010
Thanks to website "The Flu Case" we have a story in English derived from reports in two German newspapers, Zeit and Tages Spiegel:
Canada: We Were Right. Prior (non-swine) flu shots increased risk of getting swine flu infection/ US News
The traditional seasonal flu vaccine may have increased the risk of infection with pandemic H1N1 swine flu, according to the results of four new studies by Canadian researchers, published in PLOS Medicine.
If accurate (and now there are at least 6 studies that agree with this conclusion), this is not an anomaly. Licensed vaccines have at times been shown to increase, paradoxically, the infections they are meant to prevent. (Then the license is withdrawn.) For details, see my prior post on this topic. According to a detailed article in CIDRAP:
Here then may be a rather serious unintended consequence of flu vaccination:
If accurate (and now there are at least 6 studies that agree with this conclusion), this is not an anomaly. Licensed vaccines have at times been shown to increase, paradoxically, the infections they are meant to prevent. (Then the license is withdrawn.) For details, see my prior post on this topic. According to a detailed article in CIDRAP:
Immunity is not a simple thing. Vaccine theory is in its infancy, and vaccine development is based on trial and error.If that finding is not the result of chance or bias that occurred despite careful study design, the researchers say, then several hypotheses might explain the increased risk. Immunization might block the cross-protective immunity created by an earlier infection. "Original antigenic sin," or immunologic memory dating back to someone's first flu infection, might create antibody responses that are cross-reactive to other flu strains, but not strong enough to be cross-protective, and thus do not neutralize the virus. Or a related phenomenon called "antibody-dependent enhancement" might lead antibodies to inadvertently enhance virus uptake and production.
Here then may be a rather serious unintended consequence of flu vaccination:
The researchers found that (getting an earlier year) seasonal flu vaccination was associated with a 68 percent increased risk of getting swine flu (infection).
Flu Inc.: How vaccines became big business/ Globe and Mail
Paul Waldie and Grant Robertson of the Globe and Mail, Canada have published a detailed investigative piece on how vaccines have been transformed into a huge industry in the space of a few years. Thirty-two percent growth per year has followed the expanding use of yearly flu vaccines (and the expanding population groups for whom it is advised). This article is a must-read explanation of the vaccine industry and the strategies it is employing. Snippets follow:
... H5N1 (avian or bird flu virus) would alter government approaches to pandemic planning. But it would also create a new and unprecedented opportunity for the global pharmaceutical industry. It was, as Dr. Ossi recalls, “an obvious commercial opportunity” for the drug companies – one that is reshaping their businesses.
In a matter of a few years, flu shots have gone from being a marginal, money-losing business to a massive profit generator for a small number of global companies, as
governments and the public hasten to protect themselves from getting sick.
Between 2004 and 2007, vaccine sales across the industry soared an average
of 32 per cent each year, with flu vaccine leading the way. That is roughly four
times faster than any other pharmaceutical product.This is the story of how that happened – how Flu Inc. grew out of nowhere, transforming a once struggling business characterized by lab closures and lawsuits into a high-profit industry in less than a decade, and of the steps the pharmaceutical industry has taken to ensure the dollars keep flowing.
The change is driven by a new way of thinking in government about how to approach future threats of a flu pandemic. Health officials have begun to see merit in pursuing a strategy of stockpiling vaccines, even at a much higher cost per dose than they paid in the past...
The problem with making vaccines
For years, scientists had tried to find a faster way to make vaccines. They chased a variety of theories, including isolating the DNA of a virus, which many researchers believed would unlock new ways to fight infections. But at its main vaccine facility in Rixensart, Belgium, Glaxo had found a way to make vaccines more potent using another kind of technology: adjuvants...
Adjuvants are like superchargers for vaccines. They are mild contaminants that cause the body to respond with a more intense immune response. When paired with antigens, the adjuvant liquid can make the vaccine's impact stronger. This allows for more doses to be produced from less antigen...
Adjuvants allowed companies to pump out more, but it is also a higher-margin business than antigens... “The barriers to enter the market are extremely high,” said Mr. Monteyne in Belgium. “You don't become a vaccine maker over night. That's why we have a few big players, and very few only.” That meant the giants could push hard to increase prices. And they did.
...the cost of a flu shot is flexible depending on whether the buyer can pay more. “We have a tiered pricing strategy,” Mr. Monteyne said. “It is mainly based on the level of income of the country.”
...Switzerland was the first country to jump in. In October, 2006, with fear over H5N1 at fever pitch, the Swiss signed a contract with Glaxo on a stockpiling deal that called for 8 million doses of avian flu vaccine, slightly more than one shot for every citizen. This emerging business – pre-pandemic treatment – was rounding into shape. Glaxo began trade-marking the names of vaccines along those lines, registering its vaccines as Prepandrix.
... There was just one problem: the H5N1 pandemic never happened. The virus stayed mostly with animals. The Swiss were left with one of the world's largest stockpiles of unused H5N1 flu vaccine. Glaxo's sales of avian flu vaccine fell 54 per cent in 2008, as countries realized their stockpiles weren't needed.
... Once a country bought a large supply of adjuvant, it was locked in as a buyer for Glaxo's antigen for years to come. Countries were not just vaccine buyers now; they were subscribers, coming back annually to the company for more and different types of shots... In the past 12 months, the number of countries using such stockpiling methods has grown to 60 from less than 10. (See discussion of how the UK is negotiating with GSK to cancel H1N1 shots and in exchange stockpile GSK's adjuvant, here.)
... Soaring vaccine sales are also pushing companies to chase profit in other types of shots. The race is now on to develop blockbuster vaccines, defined as those that bring in more than $1-billion annually. Two recently developed vaccines – Prevnar for pneumonia and Gardasil for cervical cancer – have become blockbusters, selling close to $2-billion a year.... It's a new marketplace.
Weekly Update on H1N1 in Maine 7/29/09
Epidemiologic Trends
A total of 20 cases have been identified since the last update, for a total of 302 confirmed and probable cases to date. Most of the cases continue to be in the southern half of the state. The number of cases is only a barometer of community transmission, not of actual case counts. US CDC and WHO are no longer providing case numbers, since increasingly the numbers of those tested are a significant underestimate of those with the infection.
Three summer camps have reported at least one confirmed case of H1N1 in the last week. All camps reporting outbreaks have been able to remain open and isolate ill children following US CDC recommendations (http://www.cdc.gov/h1n1flu/sick.htm). Many camps are starting their second sessions and having visiting days, so prevention and screening efforts have increased.
Massachusetts, which has had more cases of H1N1 than Maine and therefore more data, has a hospitalization rate of about 12%, which is close to the national rate for H1N1 of 11%. This is significantly higher than the hospitalization rate for seasonal influenza, which is about 1%. Seasonal influenza is most serious in those 65 and older, while the average age for those most seriously ill with H1N1 in MA is 14. Out of the 5 deaths in MA, 3 had underlying conditions and 2 did not.
Since the southern hemisphere is in its seasonal influenza (winter) season, with both H1N1 and seasonal influenza strains circulating, the situation there is being monitored carefully as a barometer of our upcoming fall/winter seasonal influenza season. Viral isolates from the southern hemisphere have not indicated any significant genetic changes thus far in H1N1, and the profile of those encountering serious illness with H1N1 there is the same as is seen in the U.S. Some countries are seeing strains on the health care systems and some have closed schools, providing strong evidence that the U.S. should move forward with H1N1 vaccine.
Respiratory Etiquette
Prevention of H1N1 is most important, especially now that the virus is becoming more widespread in Maine. Respiratory etiquette (covering coughs and sneezes with a sleeve or tissue, washing hands frequently, and staying home if ill with a fever) is a shared responsibility of everyone in Maine, especially to protect people who are at higher risk for complications from H1N1. Those at higher risk for complications from H1N1 should take extra precautions (see CDC Information for Specific Groups: http://www.cdc.gov/h1n1flu/groups.htm
and Maine CDC’s H1N1 website at http://www.maine.gov/dhhs/boh/swine-flu-2009.shtml).
Vaccination
Maine CDC is working with a number of statewide partners to plan for large scale vaccine campaigns this fall. The first is a school-located seasonal influenza vaccine campaign. The FDA has approved the vaccine for 2009-2010 seasonal influenza (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172772.htm).
The Advisory Committee on Immunization Practices (ACIP) has released recommendations for seasonal influenza vaccine, including that all children ages 6 months to 18 years be vaccinated against seasonal influenza, and that vaccination efforts should begin as soon as vaccine is available and continue through the influenza season. (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0724a1.htm?s_cid=rr58e0724a1_e)
Maine CDC staff continues to meet weekly to plan for the possible arrival of H1N1 vaccine later in the fall, which may be a two-dose vaccine a month apart. US CDC has updated its Q&A on H1N1 vaccine (http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm). Clinical trials for the H1N1 vaccine are starting soon (http://www.nih.gov/news/health/jul2009/niaid-22.htm).
H1N1 Summit planned for August 20
Maine CDC continues to work closely with high-risk settings and organizations on preparing for a possible escalation of H1N1 in the fall, especially as schools reconvene and transmission is then expected to pick up. Maine CDC/DHHS, Maine Emergency Management Agency, and Maine Department of Education are co-sponsoring an H1N1 Influenza Preparedness Summit 8 a.m. to 4 p.m. Aug. 20 at the Augusta Civic Center, 76 Community Drive.
A $15 registration fee is required, with scholarships by request. For more information, contact MCD Meeting Services at conferences@mcd.org or 207-622-7566, ext 232. To register online: http://www.mcdregistration.org/signup.asp?ID=172
H1N1 Vaccine Q&A (source: US CDC)
Q. What are the plans for developing novel H1N1 vaccine?
A. Vaccines are the most powerful public health tool for control of influenza, and the U.S. government is working closely with manufacturers to take steps in the process to manufacture a novel H1N1 vaccine. Working together with scientists in the public and private sector, CDC has isolated the new H1N1 virus and modified the virus so that it can be used to make hundreds of millions of doses of vaccine. Vaccine manufacturers are now using these materials to begin vaccine production. Making vaccine is a multi-step process which takes several months to complete. Candidate vaccines will be tested in clinical trials over the few months.
Q. When is it expected that the novel H1N1 vaccine will be available?
A. The novel H1N1 vaccine is expected to be available in the fall. More specific dates cannot be provided at this time as vaccine availability depends on several factors including manufacturing time and time needed to conduct clinical trials
Q. Will the seasonal flu vaccine also protect against the novel H1N1 flu?
A. The seasonal flu vaccine is not expected to protect against the novel H1N1 flu.
Q. Can the seasonal vaccine and the novel H1N1 vaccine be given at the same time?
A. Clinical trial results will be necessary to confirm that novel H1N1 and seasonal vaccine will be safe and effective if given at the same time. We expect the seasonal vaccine to be available earlier than the H1N1 vaccine. The usual seasonal influenza viruses are still expected to cause illness this fall and winter. Individuals are encouraged to get their seasonal flu vaccine as soon as it is available.
Q. Who will be recommended as priority groups to receive the novel H1N1 vaccine?
A. Based on what we're currently seeing with respect to the virus and epidemiologic data, states, communities, and health care providers should begin planning strategies for how they will vaccinate younger people (children and younger adults), pregnant women, healthcare personnel, and people who have underlying health conditions. The Advisory Committee on Immunization Practices (ACIP) and other federal advisory bodies will continue to monitor the virus and review epidemiologic data over the summer. We'll be looking to the ACIP and other stakeholders, as well as the public, as we move forward in our planning. It is possible that vaccine priority groups will differ from earlier guidance as more data becomes available however it's very important for planning to continue based on information currently available.
Q. Where will the vaccine be available?
A. Every state is developing a vaccine delivery plan. Vaccine will be available in a combination of settings such as vaccination clinics organized by local health departments, healthcare provider offices, schools, and other private settings, such as pharmacies and workplaces.
Q. Are there other ways to prevent the spread of illness?
A. Take everyday actions to stay healthy.
· Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
· Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hands cleaners are also effective.
· Avoid touching your eyes, nose or mouth. Germs spread that way.
· Stay home if you get sick. CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.
Follow public health advice regarding school closures, avoiding crowds and other social distancing measures. These measures will continue to be important after a novel H1N1 vaccine is available because they can prevent the spread of other viruses that cause respiratory infections.
Q. What about the use of antivirals to treat novel H1N1 infection?
A. Antiviral drugs are prescription medicines (pills, liquid or an inhaled powder) that fight against the flu by keeping flu viruses from reproducing in your body. If you get sick, antiviral drugs can make your illness milder and make you feel better faster. They may also prevent serious flu complications. This fall, antivirals may be prioritized for persons with severe illness or those at higher risk for flu complications.
Neurologic Complications Associated with H1N1 Infection in Children
This US CDC MMWR report describes the clinical findings related to four children in Dallas, Texas, who experienced neurological complications associated with influenza A (H1N1) virus infection in May. All four patients recovered fully. These findings indicate that, as with seasonal influenza, neurologic complications can occur after respiratory tract infection with novel influenza A (H1N1) virus.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5828a2.htm?s_cid=mm5828a2_e
Other New or Recently Updated US CDC H1N1 Guidance or News
Interim Guidance for People who have Close Contact with Pigs in Non-commercial Settings
http://www.cdc.gov/h1n1flu/guidelines_pig_workers.htm
H1N1 Monitoring Questions and Answers
http://www.cdc.gov/h1n1flu/reportingqa.htm
For more information
U.S. CDC H1N1 Recommendations and Guidance
http://www.cdc.gov/h1n1flu/recommendations.htm
http://www.cdc.gov/h1n1flu/guidance/
Maine CDC H1N1 Website
http://www.maine.gov/dhhs/boh/swine-flu-2009.shtml
Maine CDC Clinical Consultation 24x7 line: 1-800-821-5821
To view surveillance data and other updates: http://www.maine.gov/dhhs/boh/swine-flu-update-archives.shtml
A total of 20 cases have been identified since the last update, for a total of 302 confirmed and probable cases to date. Most of the cases continue to be in the southern half of the state. The number of cases is only a barometer of community transmission, not of actual case counts. US CDC and WHO are no longer providing case numbers, since increasingly the numbers of those tested are a significant underestimate of those with the infection.
Three summer camps have reported at least one confirmed case of H1N1 in the last week. All camps reporting outbreaks have been able to remain open and isolate ill children following US CDC recommendations (http://www.cdc.gov/h1n1flu/sick.htm). Many camps are starting their second sessions and having visiting days, so prevention and screening efforts have increased.
Massachusetts, which has had more cases of H1N1 than Maine and therefore more data, has a hospitalization rate of about 12%, which is close to the national rate for H1N1 of 11%. This is significantly higher than the hospitalization rate for seasonal influenza, which is about 1%. Seasonal influenza is most serious in those 65 and older, while the average age for those most seriously ill with H1N1 in MA is 14. Out of the 5 deaths in MA, 3 had underlying conditions and 2 did not.
Since the southern hemisphere is in its seasonal influenza (winter) season, with both H1N1 and seasonal influenza strains circulating, the situation there is being monitored carefully as a barometer of our upcoming fall/winter seasonal influenza season. Viral isolates from the southern hemisphere have not indicated any significant genetic changes thus far in H1N1, and the profile of those encountering serious illness with H1N1 there is the same as is seen in the U.S. Some countries are seeing strains on the health care systems and some have closed schools, providing strong evidence that the U.S. should move forward with H1N1 vaccine.
Respiratory Etiquette
Prevention of H1N1 is most important, especially now that the virus is becoming more widespread in Maine. Respiratory etiquette (covering coughs and sneezes with a sleeve or tissue, washing hands frequently, and staying home if ill with a fever) is a shared responsibility of everyone in Maine, especially to protect people who are at higher risk for complications from H1N1. Those at higher risk for complications from H1N1 should take extra precautions (see CDC Information for Specific Groups: http://www.cdc.gov/h1n1flu/groups.htm
and Maine CDC’s H1N1 website at http://www.maine.gov/dhhs/boh/swine-flu-2009.shtml).
Vaccination
Maine CDC is working with a number of statewide partners to plan for large scale vaccine campaigns this fall. The first is a school-located seasonal influenza vaccine campaign. The FDA has approved the vaccine for 2009-2010 seasonal influenza (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172772.htm).
The Advisory Committee on Immunization Practices (ACIP) has released recommendations for seasonal influenza vaccine, including that all children ages 6 months to 18 years be vaccinated against seasonal influenza, and that vaccination efforts should begin as soon as vaccine is available and continue through the influenza season. (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0724a1.htm?s_cid=rr58e0724a1_e)
Maine CDC staff continues to meet weekly to plan for the possible arrival of H1N1 vaccine later in the fall, which may be a two-dose vaccine a month apart. US CDC has updated its Q&A on H1N1 vaccine (http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm). Clinical trials for the H1N1 vaccine are starting soon (http://www.nih.gov/news/health/jul2009/niaid-22.htm).
H1N1 Summit planned for August 20
Maine CDC continues to work closely with high-risk settings and organizations on preparing for a possible escalation of H1N1 in the fall, especially as schools reconvene and transmission is then expected to pick up. Maine CDC/DHHS, Maine Emergency Management Agency, and Maine Department of Education are co-sponsoring an H1N1 Influenza Preparedness Summit 8 a.m. to 4 p.m. Aug. 20 at the Augusta Civic Center, 76 Community Drive.
A $15 registration fee is required, with scholarships by request. For more information, contact MCD Meeting Services at conferences@mcd.org or 207-622-7566, ext 232. To register online: http://www.mcdregistration.org/signup.asp?ID=172
H1N1 Vaccine Q&A (source: US CDC)
Q. What are the plans for developing novel H1N1 vaccine?
A. Vaccines are the most powerful public health tool for control of influenza, and the U.S. government is working closely with manufacturers to take steps in the process to manufacture a novel H1N1 vaccine. Working together with scientists in the public and private sector, CDC has isolated the new H1N1 virus and modified the virus so that it can be used to make hundreds of millions of doses of vaccine. Vaccine manufacturers are now using these materials to begin vaccine production. Making vaccine is a multi-step process which takes several months to complete. Candidate vaccines will be tested in clinical trials over the few months.
Q. When is it expected that the novel H1N1 vaccine will be available?
A. The novel H1N1 vaccine is expected to be available in the fall. More specific dates cannot be provided at this time as vaccine availability depends on several factors including manufacturing time and time needed to conduct clinical trials
Q. Will the seasonal flu vaccine also protect against the novel H1N1 flu?
A. The seasonal flu vaccine is not expected to protect against the novel H1N1 flu.
Q. Can the seasonal vaccine and the novel H1N1 vaccine be given at the same time?
A. Clinical trial results will be necessary to confirm that novel H1N1 and seasonal vaccine will be safe and effective if given at the same time. We expect the seasonal vaccine to be available earlier than the H1N1 vaccine. The usual seasonal influenza viruses are still expected to cause illness this fall and winter. Individuals are encouraged to get their seasonal flu vaccine as soon as it is available.
Q. Who will be recommended as priority groups to receive the novel H1N1 vaccine?
A. Based on what we're currently seeing with respect to the virus and epidemiologic data, states, communities, and health care providers should begin planning strategies for how they will vaccinate younger people (children and younger adults), pregnant women, healthcare personnel, and people who have underlying health conditions. The Advisory Committee on Immunization Practices (ACIP) and other federal advisory bodies will continue to monitor the virus and review epidemiologic data over the summer. We'll be looking to the ACIP and other stakeholders, as well as the public, as we move forward in our planning. It is possible that vaccine priority groups will differ from earlier guidance as more data becomes available however it's very important for planning to continue based on information currently available.
Q. Where will the vaccine be available?
A. Every state is developing a vaccine delivery plan. Vaccine will be available in a combination of settings such as vaccination clinics organized by local health departments, healthcare provider offices, schools, and other private settings, such as pharmacies and workplaces.
Q. Are there other ways to prevent the spread of illness?
A. Take everyday actions to stay healthy.
· Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
· Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hands cleaners are also effective.
· Avoid touching your eyes, nose or mouth. Germs spread that way.
· Stay home if you get sick. CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.
Follow public health advice regarding school closures, avoiding crowds and other social distancing measures. These measures will continue to be important after a novel H1N1 vaccine is available because they can prevent the spread of other viruses that cause respiratory infections.
Q. What about the use of antivirals to treat novel H1N1 infection?
A. Antiviral drugs are prescription medicines (pills, liquid or an inhaled powder) that fight against the flu by keeping flu viruses from reproducing in your body. If you get sick, antiviral drugs can make your illness milder and make you feel better faster. They may also prevent serious flu complications. This fall, antivirals may be prioritized for persons with severe illness or those at higher risk for flu complications.
Neurologic Complications Associated with H1N1 Infection in Children
This US CDC MMWR report describes the clinical findings related to four children in Dallas, Texas, who experienced neurological complications associated with influenza A (H1N1) virus infection in May. All four patients recovered fully. These findings indicate that, as with seasonal influenza, neurologic complications can occur after respiratory tract infection with novel influenza A (H1N1) virus.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5828a2.htm?s_cid=mm5828a2_e
Other New or Recently Updated US CDC H1N1 Guidance or News
Interim Guidance for People who have Close Contact with Pigs in Non-commercial Settings
http://www.cdc.gov/h1n1flu/guidelines_pig_workers.htm
H1N1 Monitoring Questions and Answers
http://www.cdc.gov/h1n1flu/reportingqa.htm
For more information
U.S. CDC H1N1 Recommendations and Guidance
http://www.cdc.gov/h1n1flu/recommendations.htm
http://www.cdc.gov/h1n1flu/guidance/
Maine CDC H1N1 Website
http://www.maine.gov/dhhs/boh/swine-flu-2009.shtml
Maine CDC Clinical Consultation 24x7 line: 1-800-821-5821
To view surveillance data and other updates: http://www.maine.gov/dhhs/boh/swine-flu-update-archives.shtml
Canada: We Were Right. Prior (non-swine) flu shots increased risk of getting swine flu infection/ US News
The traditional seasonal flu vaccine may have increased the risk of infection with pandemic H1N1 swine flu, according to the results of four new studies by Canadian researchers, published in PLOS Medicine.
If accurate (and now there are at least 6 studies that agree with this conclusion), this is not an anomaly. Licensed vaccines have at times been shown to increase, paradoxically, the infections they are meant to prevent. (Then the license is withdrawn.) For details, see my prior post on this topic. According to a detailed article in CIDRAP:
Here then may be a rather serious unintended consequence of flu vaccination:
If accurate (and now there are at least 6 studies that agree with this conclusion), this is not an anomaly. Licensed vaccines have at times been shown to increase, paradoxically, the infections they are meant to prevent. (Then the license is withdrawn.) For details, see my prior post on this topic. According to a detailed article in CIDRAP:
Immunity is not a simple thing. Vaccine theory is in its infancy, and vaccine development is based on trial and error.If that finding is not the result of chance or bias that occurred despite careful study design, the researchers say, then several hypotheses might explain the increased risk. Immunization might block the cross-protective immunity created by an earlier infection. "Original antigenic sin," or immunologic memory dating back to someone's first flu infection, might create antibody responses that are cross-reactive to other flu strains, but not strong enough to be cross-protective, and thus do not neutralize the virus. Or a related phenomenon called "antibody-dependent enhancement" might lead antibodies to inadvertently enhance virus uptake and production.
Here then may be a rather serious unintended consequence of flu vaccination:
The researchers found that (getting an earlier year) seasonal flu vaccination was associated with a 68 percent increased risk of getting swine flu (infection).
H1N1 vaccine study investigating hints of complications from vaccine/ Washington Post
Rob Stein at the Post discusses a "hint" that swine flu vaccine may have caused increased cases of Guillain Barre Syndrome, Bell's Pallsy and thrombocytopenia.
The US CDC, unlike its counterpart in Australia, manages the news on vaccine adverse events closely, especially for swine flu. Remember that CDC hosted a meeting for invited journalists and bloggers to teach them not to report small numbers of adverse events at the start of the swine flu vaccination program. Attendees were not permitted to report on the meeting. I blogged on this some months back.
We would therefore not be hearing about this hint unless the evidence was quite strong. Furthermore, all 3 diagnoses are known to be side effects of other vaccines. GBS has been caused by flu vaccines. CDC identified increased cases of Bell's Palsy reported following influenza vaccination in 2004. Thrombocytopenia cases are increased after measles vaccine, according to FDA, and increased after MMR vaccines.
This increases the odds these diseases may be side effects of swine flu vaccine. Because of enhanced swine flu vaccine adverse event surveillance in multiple countries, it will be difficult for one or two countries to cover up their findings.
The US CDC, unlike its counterpart in Australia, manages the news on vaccine adverse events closely, especially for swine flu. Remember that CDC hosted a meeting for invited journalists and bloggers to teach them not to report small numbers of adverse events at the start of the swine flu vaccination program. Attendees were not permitted to report on the meeting. I blogged on this some months back.
We would therefore not be hearing about this hint unless the evidence was quite strong. Furthermore, all 3 diagnoses are known to be side effects of other vaccines. GBS has been caused by flu vaccines. CDC identified increased cases of Bell's Palsy reported following influenza vaccination in 2004. Thrombocytopenia cases are increased after measles vaccine, according to FDA, and increased after MMR vaccines.
This increases the odds these diseases may be side effects of swine flu vaccine. Because of enhanced swine flu vaccine adverse event surveillance in multiple countries, it will be difficult for one or two countries to cover up their findings.
David Kelly post mortem to be kept secret for 70 years as doctors accuse Lord Hutton of concealing vital information / Daily Mail
The Chilcot Inquiry into the facts surrounding the decision for Great Briitain to enter the Iraq War has now been lobbed a ball it probably can't duck.
A group of physicians have asked for release of data--including autopsy reports--on the death of David Kelly. Kelly, a WMD expert, told the BBC that Blair's government had "sexed up" a report on Iraq's WMD: that there was no evidence for the claim that nuclear weapons could be sent overseas by Saddam Hussein within 45 minutes. Shortly thereafter he was found dead in the woods near his home.
His death was not explained satisfactorily. Now it turns out that Lord Hutton, who convened an earlier inquiry into Kelly's death that many regard as a cover-up, sealed all the records for 70 years. This new fact seems to clinch Hutton as a cover-upper.
Now the Chilcot hearing will almost certainly need to delve into the circumstances of Kelly's death, and behind all that is the role Labor Party leaders may have had in it. So far, Chilcot has dodged the entire issue of Kelly.
UPDATE: The TimesOnline (and other UK media) have reported that Lord Hutton will be making classified documents available to the 5 doctors investigating Kelly's death. The Times site has a nice clickable summary of the witnesses' testimony at the Chilcott hearing, where Tony Blair dodged and prevaricated on Jan. 29.
A group of physicians have asked for release of data--including autopsy reports--on the death of David Kelly. Kelly, a WMD expert, told the BBC that Blair's government had "sexed up" a report on Iraq's WMD: that there was no evidence for the claim that nuclear weapons could be sent overseas by Saddam Hussein within 45 minutes. Shortly thereafter he was found dead in the woods near his home.
His death was not explained satisfactorily. Now it turns out that Lord Hutton, who convened an earlier inquiry into Kelly's death that many regard as a cover-up, sealed all the records for 70 years. This new fact seems to clinch Hutton as a cover-upper.
Now the Chilcot hearing will almost certainly need to delve into the circumstances of Kelly's death, and behind all that is the role Labor Party leaders may have had in it. So far, Chilcot has dodged the entire issue of Kelly.
UPDATE: The TimesOnline (and other UK media) have reported that Lord Hutton will be making classified documents available to the 5 doctors investigating Kelly's death. The Times site has a nice clickable summary of the witnesses' testimony at the Chilcott hearing, where Tony Blair dodged and prevaricated on Jan. 29.
David Kelly post mortem to be kept secret for 70 years as doctors accuse Lord Hutton of concealing vital information / Daily Mail
The Chilcot Inquiry into the facts surrounding the decision for Great Briitain to enter the Iraq War has now been lobbed a ball it probably can't duck.
A group of physicians have asked for release of data--including autopsy reports--on the death of David Kelly. Kelly, a WMD expert, told the BBC that Blair's government had "sexed up" a report on Iraq's WMD: that there was no evidence for the claim that nuclear weapons could be sent overseas by Saddam Hussein within 45 minutes. Shortly thereafter he was found dead in the woods near his home.
His death was not explained satisfactorily. Now it turns out that Lord Hutton, who convened an earlier inquiry into Kelly's death that many regard as a cover-up, sealed all the records for 70 years. This new fact seems to clinch Hutton as a cover-upper.
Now the Chilcot hearing will almost certainly need to delve into the circumstances of Kelly's death, and behind all that is the role Labor Party leaders may have had in it. So far, Chilcot has dodged the entire issue of Kelly.
UPDATE: The TimesOnline (and other UK media) have reported that Lord Hutton will be making classified documents available to the 5 doctors investigating Kelly's death. The Times site has a nice clickable summary of the witnesses' testimony at the Chilcott hearing, where Tony Blair dodged and prevaricated on Jan. 29.
A group of physicians have asked for release of data--including autopsy reports--on the death of David Kelly. Kelly, a WMD expert, told the BBC that Blair's government had "sexed up" a report on Iraq's WMD: that there was no evidence for the claim that nuclear weapons could be sent overseas by Saddam Hussein within 45 minutes. Shortly thereafter he was found dead in the woods near his home.
His death was not explained satisfactorily. Now it turns out that Lord Hutton, who convened an earlier inquiry into Kelly's death that many regard as a cover-up, sealed all the records for 70 years. This new fact seems to clinch Hutton as a cover-upper.
Now the Chilcot hearing will almost certainly need to delve into the circumstances of Kelly's death, and behind all that is the role Labor Party leaders may have had in it. So far, Chilcot has dodged the entire issue of Kelly.
UPDATE: The TimesOnline (and other UK media) have reported that Lord Hutton will be making classified documents available to the 5 doctors investigating Kelly's death. The Times site has a nice clickable summary of the witnesses' testimony at the Chilcott hearing, where Tony Blair dodged and prevaricated on Jan. 29.
H1N1 vaccine study investigating hints of complications from vaccine/ Washington Post
Rob Stein at the Post discusses a "hint" that swine flu vaccine may have caused increased cases of Guillain Barre Syndrome, Bell's Pallsy and thrombocytopenia.
The US CDC, unlike its counterpart in Australia, manages the news on vaccine adverse events closely, especially for swine flu. Remember that CDC hosted a meeting for invited journalists and bloggers to teach them not to report small numbers of adverse events at the start of the swine flu vaccination program. Attendees were not permitted to report on the meeting. I blogged on this some months back.
We would therefore not be hearing about this hint unless the evidence was quite strong. Furthermore, all 3 diagnoses are known to be side effects of other vaccines. GBS has been caused by flu vaccines. CDC identified increased cases of Bell's Palsy reported following influenza vaccination in 2004. Thrombocytopenia cases are increased after measles vaccine, according to FDA, and increased after MMR vaccines.
This increases the odds these diseases may be side effects of swine flu vaccine. Because of enhanced swine flu vaccine adverse event surveillance in multiple countries, it will be difficult for one or two countries to cover up their findings.
The US CDC, unlike its counterpart in Australia, manages the news on vaccine adverse events closely, especially for swine flu. Remember that CDC hosted a meeting for invited journalists and bloggers to teach them not to report small numbers of adverse events at the start of the swine flu vaccination program. Attendees were not permitted to report on the meeting. I blogged on this some months back.
We would therefore not be hearing about this hint unless the evidence was quite strong. Furthermore, all 3 diagnoses are known to be side effects of other vaccines. GBS has been caused by flu vaccines. CDC identified increased cases of Bell's Palsy reported following influenza vaccination in 2004. Thrombocytopenia cases are increased after measles vaccine, according to FDA, and increased after MMR vaccines.
This increases the odds these diseases may be side effects of swine flu vaccine. Because of enhanced swine flu vaccine adverse event surveillance in multiple countries, it will be difficult for one or two countries to cover up their findings.
Nadler Renews Call for Independent Investigation of Anthrax Attacks
Thursday, 04 March 2010 WASHINGTON, D.C. – Congressman Jerrold Nadler (D-NY), Chair of the House Judiciary Subcommittee on the Constitution, Civil Rights and Civil Liberties, reiterated his call for an independent investigation into the 2001 anthrax attacks which killed five people and sickened 17. He issued the following statement:
“Despite the FBI’s assertion that the case of the anthrax attacks is closed, there are still many troubling questions. For example, in a 2008 Judiciary Committee hearing, I asked FBI Director Robert Mueller whether Bruce Ivins was capable of producing the weaponized anthrax that was used in the attacks. To this day, it is still far from clear that Mr. Ivins had either the know-how or access to the equipment needed to produce the material. Because the FBI has not sufficiently answered such questions, I join Congressman Holt in urging an independent investigation of the case.”
Another Attempt to Delay Release of David Kelly's Autopsy Records/ Daily Mail
In January, the Daily Mail revealed that Lord Hutton ordered David Kelly's post-mortem records to be barred from public access for 70 years. Hutton then responded that he would make the records available to physicians conducting a public inquiry on the death.
Instead, the UK's Ministry of Justice said the request for information would be treated under the UK's Freedom of Information Act, which gave the government the right to refuse access.
After questioning of the MoJ by the Daily Mail, the UK government has now said it will deal with the request "under normal terms."
Instead, the UK's Ministry of Justice said the request for information would be treated under the UK's Freedom of Information Act, which gave the government the right to refuse access.
After questioning of the MoJ by the Daily Mail, the UK government has now said it will deal with the request "under normal terms."
Weekly update on H1N1 in Maine 1/14/10
Flu Activity in Maine and the US
We continue to see H1N1 in Maine, including three new hospitalizations this week – one in a child younger than 5, another child younger than 18, and an adult in the 50-64 age range. There was also an outbreak of H1N1 at a long term care facility. Although H1N1 flu activity has decreased in Maine in recent weeks, there have been increases in H1N1 illness in other areas of the U.S.
Many people are still susceptible to this virus and would benefit from vaccination. Being vaccinated not only protects you, but it helps protect the people around you who are more likely to suffer serious complications from the flu.
Flu is unpredictable, but it often comes in waves. There was a mild surge in the spring of 1957, followed by a large surge in the fall, another large one in the winter of 1958, and others following that with the virus circulating for several years. All pandemics are different, but most have multiple waves of illness and death.
H1N1 Vaccine Supply
There is now plenty of vaccine in Maine, so it’s an excellent time for people who have not been vaccinated against H1N1 and seasonal flu to do so before the next wave of disease. Nearly 800,000 doses of H1N1 vaccine have been distributed statewide since October. Close to 500 health care providers in the state have received H1N1 vaccine. Call your health care provider, or get the list of public vaccine clinics by calling 211 from 8 a.m. to 8 p.m. or visiting www.maineflu.gov (all clinics posted in bold are free).
Maine CDC recommends that health care providers offer H1N1 vaccine to every patient at every visit, every hospitalization, or other health care encounter, assuming contraindications do not exist.
Treatment Recommendations
Maine CDC issued a health alert on Jan. 11 to reinforce recommendations for early treatment of patients with increased risk of complications from influenza. Early treatment for influenza may prevent secondary bacterial infections. This alert can be viewed here: http://www.maine.gov/tools/whatsnew/index.php?topic=DHHS-HAN&id=88550&v=alert
If you think you have the flu, cannot reach your doctor, and your health plan does not have a nurse call line available, you may call 2-1-1 from 8 a.m. to 8 p.m. to be connected with a health professional who can assess your symptoms.
Information for People with Chronic Underlying Health Conditions
Pneumonia, bronchitis, acute respiratory distress syndrome, sinus infections and ear infections are examples of flu-related complications. The flu can also make chronic health problems worse. H1N1 has caused more deaths among adults with chronic medical conditions than in any other group. All 18 H1N1-related deaths in Maine have been in adults with chronic underlying conditions.
If you have a high-risk condition, getting vaccinated is the single best action you can take to protect yourself from the flu. Still, most adults with high-risk conditions have not been vaccinated yet. Many people in these groups do not realize that their medical conditions increase their risk. The following conditions put people are risk for flu-related complications:
· asthma;
· heart disease
· chronic lung disease (such as chronic obstructive pulmonary disease [COPD] and cystic fibrosis);
· diabetes and other endocrine disorders;
· neurological or neurodevelopmental disorders, and especially those that affect lung capacity (muscular dystrophy, cerebral palsy, strokes, etc);
· blood disorders, such as sickle cell disease;
· kidney and liver disorders;
· weakened immune system due to disease or medication, such HIV/AIDS, cancer, or steroids;
· long-term aspirin therapy in people younger than 19.
If you have a chronic health condition and have not yet received your vaccine against H1N1, get one now. Contact your health care provider, specialist, call 2-1-1 from 8 a.m. to 8 p.m. for a list of public clinics, or check www.maineflu.gov (clinics listed in bold are free).
If you have an underlying health condition and experience flu-like symptoms, contact your health care provider immediately to receive a prescription for antiviral medications (such as Tamiflu®).
To read the full update: bit.ly/8CFsPI
We continue to see H1N1 in Maine, including three new hospitalizations this week – one in a child younger than 5, another child younger than 18, and an adult in the 50-64 age range. There was also an outbreak of H1N1 at a long term care facility. Although H1N1 flu activity has decreased in Maine in recent weeks, there have been increases in H1N1 illness in other areas of the U.S.
Many people are still susceptible to this virus and would benefit from vaccination. Being vaccinated not only protects you, but it helps protect the people around you who are more likely to suffer serious complications from the flu.
Flu is unpredictable, but it often comes in waves. There was a mild surge in the spring of 1957, followed by a large surge in the fall, another large one in the winter of 1958, and others following that with the virus circulating for several years. All pandemics are different, but most have multiple waves of illness and death.
H1N1 Vaccine Supply
There is now plenty of vaccine in Maine, so it’s an excellent time for people who have not been vaccinated against H1N1 and seasonal flu to do so before the next wave of disease. Nearly 800,000 doses of H1N1 vaccine have been distributed statewide since October. Close to 500 health care providers in the state have received H1N1 vaccine. Call your health care provider, or get the list of public vaccine clinics by calling 211 from 8 a.m. to 8 p.m. or visiting www.maineflu.gov (all clinics posted in bold are free).
Maine CDC recommends that health care providers offer H1N1 vaccine to every patient at every visit, every hospitalization, or other health care encounter, assuming contraindications do not exist.
Treatment Recommendations
Maine CDC issued a health alert on Jan. 11 to reinforce recommendations for early treatment of patients with increased risk of complications from influenza. Early treatment for influenza may prevent secondary bacterial infections. This alert can be viewed here: http://www.maine.gov/tools/whatsnew/index.php?topic=DHHS-HAN&id=88550&v=alert
If you think you have the flu, cannot reach your doctor, and your health plan does not have a nurse call line available, you may call 2-1-1 from 8 a.m. to 8 p.m. to be connected with a health professional who can assess your symptoms.
Information for People with Chronic Underlying Health Conditions
Pneumonia, bronchitis, acute respiratory distress syndrome, sinus infections and ear infections are examples of flu-related complications. The flu can also make chronic health problems worse. H1N1 has caused more deaths among adults with chronic medical conditions than in any other group. All 18 H1N1-related deaths in Maine have been in adults with chronic underlying conditions.
If you have a high-risk condition, getting vaccinated is the single best action you can take to protect yourself from the flu. Still, most adults with high-risk conditions have not been vaccinated yet. Many people in these groups do not realize that their medical conditions increase their risk. The following conditions put people are risk for flu-related complications:
· asthma;
· heart disease
· chronic lung disease (such as chronic obstructive pulmonary disease [COPD] and cystic fibrosis);
· diabetes and other endocrine disorders;
· neurological or neurodevelopmental disorders, and especially those that affect lung capacity (muscular dystrophy, cerebral palsy, strokes, etc);
· blood disorders, such as sickle cell disease;
· kidney and liver disorders;
· weakened immune system due to disease or medication, such HIV/AIDS, cancer, or steroids;
· long-term aspirin therapy in people younger than 19.
If you have a chronic health condition and have not yet received your vaccine against H1N1, get one now. Contact your health care provider, specialist, call 2-1-1 from 8 a.m. to 8 p.m. for a list of public clinics, or check www.maineflu.gov (clinics listed in bold are free).
If you have an underlying health condition and experience flu-like symptoms, contact your health care provider immediately to receive a prescription for antiviral medications (such as Tamiflu®).
To read the full update: bit.ly/8CFsPI
Flu Inc.: How vaccines became big business/ Globe and Mail
Paul Waldie and Grant Robertson of the Globe and Mail, Canada have published a detailed investigative piece on how vaccines have been transformed into a huge industry in the space of a few years. Thirty-two percent growth per year has followed the expanding use of yearly flu vaccines (and the expanding population groups for whom it is advised). This article is a must-read explanation of the vaccine industry and the strategies it is employing. Snippets follow:
... H5N1 (avian or bird flu virus) would alter government approaches to pandemic planning. But it would also create a new and unprecedented opportunity for the global pharmaceutical industry. It was, as Dr. Ossi recalls, “an obvious commercial opportunity” for the drug companies – one that is reshaping their businesses.
In a matter of a few years, flu shots have gone from being a marginal, money-losing business to a massive profit generator for a small number of global companies, as
governments and the public hasten to protect themselves from getting sick.
Between 2004 and 2007, vaccine sales across the industry soared an average
of 32 per cent each year, with flu vaccine leading the way. That is roughly four
times faster than any other pharmaceutical product.This is the story of how that happened – how Flu Inc. grew out of nowhere, transforming a once struggling business characterized by lab closures and lawsuits into a high-profit industry in less than a decade, and of the steps the pharmaceutical industry has taken to ensure the dollars keep flowing.
The change is driven by a new way of thinking in government about how to approach future threats of a flu pandemic. Health officials have begun to see merit in pursuing a strategy of stockpiling vaccines, even at a much higher cost per dose than they paid in the past...
The problem with making vaccines
For years, scientists had tried to find a faster way to make vaccines. They chased a variety of theories, including isolating the DNA of a virus, which many researchers believed would unlock new ways to fight infections. But at its main vaccine facility in Rixensart, Belgium, Glaxo had found a way to make vaccines more potent using another kind of technology: adjuvants...
Adjuvants are like superchargers for vaccines. They are mild contaminants that cause the body to respond with a more intense immune response. When paired with antigens, the adjuvant liquid can make the vaccine's impact stronger. This allows for more doses to be produced from less antigen...
Adjuvants allowed companies to pump out more, but it is also a higher-margin business than antigens... “The barriers to enter the market are extremely high,” said Mr. Monteyne in Belgium. “You don't become a vaccine maker over night. That's why we have a few big players, and very few only.” That meant the giants could push hard to increase prices. And they did.
...the cost of a flu shot is flexible depending on whether the buyer can pay more. “We have a tiered pricing strategy,” Mr. Monteyne said. “It is mainly based on the level of income of the country.”
...Switzerland was the first country to jump in. In October, 2006, with fear over H5N1 at fever pitch, the Swiss signed a contract with Glaxo on a stockpiling deal that called for 8 million doses of avian flu vaccine, slightly more than one shot for every citizen. This emerging business – pre-pandemic treatment – was rounding into shape. Glaxo began trade-marking the names of vaccines along those lines, registering its vaccines as Prepandrix.
... There was just one problem: the H5N1 pandemic never happened. The virus stayed mostly with animals. The Swiss were left with one of the world's largest stockpiles of unused H5N1 flu vaccine. Glaxo's sales of avian flu vaccine fell 54 per cent in 2008, as countries realized their stockpiles weren't needed.
... Once a country bought a large supply of adjuvant, it was locked in as a buyer for Glaxo's antigen for years to come. Countries were not just vaccine buyers now; they were subscribers, coming back annually to the company for more and different types of shots... In the past 12 months, the number of countries using such stockpiling methods has grown to 60 from less than 10. (See discussion of how the UK is negotiating with GSK to cancel H1N1 shots and in exchange stockpile GSK's adjuvant, here.)
... Soaring vaccine sales are also pushing companies to chase profit in other types of shots. The race is now on to develop blockbuster vaccines, defined as those that bring in more than $1-billion annually. Two recently developed vaccines – Prevnar for pneumonia and Gardasil for cervical cancer – have become blockbusters, selling close to $2-billion a year.... It's a new marketplace.
20 Mayıs 2010 Perşembe
Canada: We Were Right. Prior (non-swine) flu shots increased risk of getting swine flu infection/ US News
The traditional seasonal flu vaccine may have increased the risk of infection with pandemic H1N1 swine flu, according to the results of four new studies by Canadian researchers, published in PLOS Medicine.
If accurate (and now there are at least 6 studies that agree with this conclusion), this is not an anomaly. Licensed vaccines have at times been shown to increase, paradoxically, the infections they are meant to prevent. (Then the license is withdrawn.) For details, see my prior post on this topic. According to a detailed article in CIDRAP:
Here then may be a rather serious unintended consequence of flu vaccination:
If accurate (and now there are at least 6 studies that agree with this conclusion), this is not an anomaly. Licensed vaccines have at times been shown to increase, paradoxically, the infections they are meant to prevent. (Then the license is withdrawn.) For details, see my prior post on this topic. According to a detailed article in CIDRAP:
Immunity is not a simple thing. Vaccine theory is in its infancy, and vaccine development is based on trial and error.If that finding is not the result of chance or bias that occurred despite careful study design, the researchers say, then several hypotheses might explain the increased risk. Immunization might block the cross-protective immunity created by an earlier infection. "Original antigenic sin," or immunologic memory dating back to someone's first flu infection, might create antibody responses that are cross-reactive to other flu strains, but not strong enough to be cross-protective, and thus do not neutralize the virus. Or a related phenomenon called "antibody-dependent enhancement" might lead antibodies to inadvertently enhance virus uptake and production.
Here then may be a rather serious unintended consequence of flu vaccination:
The researchers found that (getting an earlier year) seasonal flu vaccination was associated with a 68 percent increased risk of getting swine flu (infection).
Another Attempt to Delay Release of David Kelly's Autopsy Records/ Daily Mail
In January, the Daily Mail revealed that Lord Hutton ordered David Kelly's post-mortem records to be barred from public access for 70 years. Hutton then responded that he would make the records available to physicians conducting a public inquiry on the death.
Instead, the UK's Ministry of Justice said the request for information would be treated under the UK's Freedom of Information Act, which gave the government the right to refuse access.
After questioning of the MoJ by the Daily Mail, the UK government has now said it will deal with the request "under normal terms."
Instead, the UK's Ministry of Justice said the request for information would be treated under the UK's Freedom of Information Act, which gave the government the right to refuse access.
After questioning of the MoJ by the Daily Mail, the UK government has now said it will deal with the request "under normal terms."
Novartis Is Celebrating. Should We?/ Huffington Post
From Dr. Sherri Tenpenny in the Dec. 8, 2009 Huffington Post:
On November 24, 2009, Novartis officially opened its first, large-scale vaccine manufacturing facility in the U.S. Located in Holly Springs, North Carolina. The project is a collaborative effort between Novartis and the U.S. Department of Health and Human Services, which contributed $457M for the design, construction, and licensing of the facility.
For its part in the deal, Novartis is required to provide two commercial-scale lots of "pre-pandemic" vaccine annually for a minimum of three years. In addition, the government has the right to exercise options to purchase influenza vaccine over the next 17 years. (1) Currently, 191 employees work at the plant but that will increase to 350 persons when fully operational, anticipated to be sometime in 2011. The Holly Springs facility will be able to roll out 150 million flu shots per year.
Even though its use has not been approved by U.S. regulators, the plant will be producing MF59 as early as December 2009.(2) MF59 is Novartis' proprietary and controversial adjuvant composed of squalene and a surfactant called Tween80, also known as polysorbate 80. Back in July, 2009, the department of HHS purchased over $343.8M of "oil-in-water" adjuvant from Norvartis.(3) It looks like the government may want to take delivery on its purchase some time soon.
All flu shots used in the U.S. are made from eggs, a time- and labor-intensive process. But the new plant will provide something different. Vaccines will be brewed from animal cells mixed with viruses in six 1,320 gallon fermenters which are owned by the U.S. government and the Department of HHS, as identified by a bright yellow, plastic plaque on the sides of the giant vats. (4)...
[Go here for the rest of the story.]
Health Reform
President Obama signed the Patient Protection and Affordable Care Act into law on March 23. Last week, he spoke about health reform when he visited Portland. The entire speech is available here.
This National Association of State Medicaid Directors document gives a side-by-side comparison of the different health care reform bills, while the Kaiser Family Foundation developed this summary of the final law and implementation timeline.
This Trust for America’s Health web page describes the prevention components of the final legislation.
The Association of Maternal and Child Health Programs’ Health Reform web page has a number of helpful links focused on the impact on maternal and child health programs as well as more general information.
This National Association of State Medicaid Directors document gives a side-by-side comparison of the different health care reform bills, while the Kaiser Family Foundation developed this summary of the final law and implementation timeline.
This Trust for America’s Health web page describes the prevention components of the final legislation.
The Association of Maternal and Child Health Programs’ Health Reform web page has a number of helpful links focused on the impact on maternal and child health programs as well as more general information.
H1N1 vaccine study investigating hints of complications from vaccine/ Washington Post
Rob Stein at the Post discusses a "hint" that swine flu vaccine may have caused increased cases of Guillain Barre Syndrome, Bell's Pallsy and thrombocytopenia.
The US CDC, unlike its counterpart in Australia, manages the news on vaccine adverse events closely, especially for swine flu. Remember that CDC hosted a meeting for invited journalists and bloggers to teach them not to report small numbers of adverse events at the start of the swine flu vaccination program. Attendees were not permitted to report on the meeting. I blogged on this some months back.
We would therefore not be hearing about this hint unless the evidence was quite strong. Furthermore, all 3 diagnoses are known to be side effects of other vaccines. GBS has been caused by flu vaccines. CDC identified increased cases of Bell's Palsy reported following influenza vaccination in 2004. Thrombocytopenia cases are increased after measles vaccine, according to FDA, and increased after MMR vaccines.
This increases the odds these diseases may be side effects of swine flu vaccine. Because of enhanced swine flu vaccine adverse event surveillance in multiple countries, it will be difficult for one or two countries to cover up their findings.
The US CDC, unlike its counterpart in Australia, manages the news on vaccine adverse events closely, especially for swine flu. Remember that CDC hosted a meeting for invited journalists and bloggers to teach them not to report small numbers of adverse events at the start of the swine flu vaccination program. Attendees were not permitted to report on the meeting. I blogged on this some months back.
We would therefore not be hearing about this hint unless the evidence was quite strong. Furthermore, all 3 diagnoses are known to be side effects of other vaccines. GBS has been caused by flu vaccines. CDC identified increased cases of Bell's Palsy reported following influenza vaccination in 2004. Thrombocytopenia cases are increased after measles vaccine, according to FDA, and increased after MMR vaccines.
This increases the odds these diseases may be side effects of swine flu vaccine. Because of enhanced swine flu vaccine adverse event surveillance in multiple countries, it will be difficult for one or two countries to cover up their findings.
Another Attempt to Delay Release of David Kelly's Autopsy Records/ Daily Mail
In January, the Daily Mail revealed that Lord Hutton ordered David Kelly's post-mortem records to be barred from public access for 70 years. Hutton then responded that he would make the records available to physicians conducting a public inquiry on the death.
Instead, the UK's Ministry of Justice said the request for information would be treated under the UK's Freedom of Information Act, which gave the government the right to refuse access.
After questioning of the MoJ by the Daily Mail, the UK government has now said it will deal with the request "under normal terms."
Instead, the UK's Ministry of Justice said the request for information would be treated under the UK's Freedom of Information Act, which gave the government the right to refuse access.
After questioning of the MoJ by the Daily Mail, the UK government has now said it will deal with the request "under normal terms."
Anthrax Questions/ Pittsburgh Tribune-Review
The U.S. Senate must help America get to the bottom of the post-9/11 anthrax attacks.
The FBI hasn't produced convincing answers. It had to pay damages to former government scientist Dr. Stephen Hatfill for wrongly labeling him a "person of interest."
It can't convict the government scientist it now blames, Dr. Bruce Ivins, because he took his own life amid FBI hounding.
And a National Academy of Sciences review of FBI scientific evidence, which the FBI itself ordered, isn't finished.
Yet the Obama Justice Department says it's a closed case.
As Cliff Kincaid of America's Survival Inc. notes, the FBI seems hellbent on exonerating al-Qaida. And left-leaning mainstream media have focused on domestic, preferably right-wing suspects -- despite evidence that al-Qaida strove to add anthrax to its arsenal.
So the Senate must follow the House's lead and require the intelligence inspector general to determine whether credible evidence exists of a link between a foreign entity and the anthrax attacks.
Mr. Kincaid chillingly points out that the FBI's handling of the case raises doubts about both its own practices and U.S. readiness for biological terror attacks. Without solid answers about the anthrax attacks, those doubts will only grow.
The FBI hasn't produced convincing answers. It had to pay damages to former government scientist Dr. Stephen Hatfill for wrongly labeling him a "person of interest."
It can't convict the government scientist it now blames, Dr. Bruce Ivins, because he took his own life amid FBI hounding.
And a National Academy of Sciences review of FBI scientific evidence, which the FBI itself ordered, isn't finished.
Yet the Obama Justice Department says it's a closed case.
As Cliff Kincaid of America's Survival Inc. notes, the FBI seems hellbent on exonerating al-Qaida. And left-leaning mainstream media have focused on domestic, preferably right-wing suspects -- despite evidence that al-Qaida strove to add anthrax to its arsenal.
So the Senate must follow the House's lead and require the intelligence inspector general to determine whether credible evidence exists of a link between a foreign entity and the anthrax attacks.
Mr. Kincaid chillingly points out that the FBI's handling of the case raises doubts about both its own practices and U.S. readiness for biological terror attacks. Without solid answers about the anthrax attacks, those doubts will only grow.
H1N1 Clinician Update
Below this blog post are some important recent (this last 2 days) updated documents from US CDC. The Treatment Algorithm for Adults, the H1N1 Vaccine Information Statements (which must be given to patients receiving the vaccine), updated information for seniors, pregnant women, other patients, and clinicians all may be of interest.
Maine CDC was one of few states that ordered its entire allotment of H1N1 vaccine this week. Our Immunization Program staff along with redeployed Maine CDC staff worked many hours to accomplish this. Over 300 health care providers were registered as H1N1 distribution sites. 8,700 doses of LAIV (Live Attenuated Influenza Vaccine), also known as nasal spray vaccine (analogous to the seasonal flu vaccine FluMist), will be arriving and distributed to about 70 clinical sites this coming week – most likely arriving at clinical sites Tuesday or Wednesday. We ask that these first few doses of vaccine be focused on healthy children, especially young children ages 2 – 5 years of age, and household contacts and caregivers of young infants under 6 months old. This LAIV is licensed for healthy non-pregnant 2 – 49 year olds, and as more vaccine arrives, this formulation should be expanded to include other high priority populations that fit the licensure parameters.
We expect to be able to order other formulations plus additional LAIV this coming week. As we are able to order and distribute more vaccine, the high priority populations it will be focused on will be expanded. For the next few weeks we anticipate focusing vaccine on the 5 high priority populations of:
· pregnant women;
· people ages 6 months – 25 years of age;
· household contacts and caregivers of young infants under 6 months old;
· people 25 – 65 years of age with underlying conditions; and
· health care workers including EMS.
Within the latter category of health care workers, we anticipate that this next several weeks the vaccine will most likely be focused on hospital-based health care workers with direct patient contact who work in emergency departments, intensive care units, labor and delivery units, and inpatient pediatric wards. As vaccine becomes more available, the priority groups it can reach can expand.
Our vaccine distribution and administration plans focus on settings where these high priority populations are in highest numbers and proportion. For instance, we are currently focused on distributing H1N1 vaccine to pediatric and obstetrical health care providers, hospitals, schools, and city health departments. This means that health care providers who have not been accepted by the end of this coming week as a distribution site most likely do not fit into these priority settings. If we are allowed more distribution sites, we may be able to expand to include these other health care providers. If not, H1N1 vaccine can easily be redistributed to these other health care providers from a distribution site. However, we ask that it still remain focused on high priority populations for now. Highlights from information sent to all current H1N1 vaccine distribution sites are below this email and the CDC documents.
Thank you for all the work you and many others are doing! It is exciting to think the vaccine is almost here, though I know these next few weeks will be quite busy for anyone involved with health care and public health.
Dora
2009-2010 Influenza Season Triage Algorithm for Adults (>18 Years) With Influenza-Like Illness
This algorithm is designed to assist physicians and those under their supervision in identifying indicators of and responses to symptoms of flu-like illness (i.e., fever with cough or sore throat). (NOTE: this guidance is not intended for use by the general public and is not a substitute for sound clinical judgment.)
Download and print the algorithm (PDF) >>
H1N1 Flu Vaccine Information Statements (VISs)
Vaccine Information Statements (VISs) are information sheets produced by CDC that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine.
Inactivated 2009 H1N1 Influenza Vaccine
(the flu shot)
Live, Intranasal 2009 H1N1 Influenza Vaccine
(the nasal spray vaccine)
Pregnancy and H1N1
Update: 2009 H1N1 Influenza Shots and Pregnant Women: Questions and Answers for Patients
Why does CDC advise pregnant women to receive the 2009 H1N1 influenza (flu) vaccine (shot)? Will the seasonal flu shot also protect against the 2009 H1N1 flu? Are there flu vaccines that pregnant women should not get? More...
2009 H1N1 Influenza Vaccine and Pregnant Women: Information for Healthcare Providers
Where can healthcare providers obtain 2009 H1N1 flu vaccine? How should healthcare providers organize their clinics for vaccination? How many vaccine doses will a pregnant woman need to get? More...
H1N1 Clinician Information
Update: H1N1 Clinicians Questions and Answers
The age for two doses is different for seasonal (6 months through 8 years) and 2009 H1N1 monovalent vaccine (6 months through 9 years) in the package inserts. Does CDC recommend that clinicians follow the recommendation in the package inserts? Can a person who has received LAIV test positive on a rapid influenza diagnostic test? And more...
Questions and Answers on 2009 H1N1 Vaccine Financing
Considerations of financing distinguish between those related to the vaccine itself, the ancillary supplies needed to administer the vaccine, and the actual administration of the vaccine.
Questions & Answers: Interim Recommendations for Clinical Use of Influenza Diagnostic Testing During the 2009-2010 Influenza Season - For Health Care Providers
What does CDC recommend this season regarding testing for influenza? What is the reason for these recommendations? Does CDC recommend diagnostic testing for patients with uncomplicated illness from suspected influenza infection? More...
Interim Recommendations for Clinical Use of Influenza Diagnostic Tests During the 2009-10 Influenza Season
To provide updated interim recommendations on influenza diagnostic testing for clinicians treating patients with suspected 2009 H1N1 influenza virus infection and to assist clinicians with testing decisions for the 2009-10 influenza season.
H1N1 Information for Patients
Preparing for the Flu: A Communication Toolkit for the Federal Workforce
The purpose of Preparing for the Flu: A Communication Toolkit for the Federal Workforce is to provide information and communication resources to help federal agencies and employees implement recommendations from CDC in planning and responding to the 2009–2010 Influenza Season.
2009 H1N1 Influenza Vaccine and Seniors
Questions and Answers about 2009 H1N1 Influenza Vaccine and Seniors
Questions & Answers: Influenza Diagnostic Testing During the 2009-2010 Flu Season - For the Public
How will I know if I have the flu this season? How can I know for certain if I have the flu this season? What kinds of flu tests are there? More...
HIGLIGHTS OF INFORMATION SENT BY MAINE CDC TO H1N1 VACCINE DISTRIBUTION SITES FRIDAY:
Distribution:
· We expect approximately 800,00 doses of vaccine to be available in Maine by early January 2010.
· H1N1 vaccine will be offered in four different presentations: 7.5mg prefilled syringes, 15mg prefilled syringes, multi-dose vials and intranasal sprayers (LAIV).
· Approximately 40% of the vaccine will be in thimerosal free presentations (prefilled syringes and LAIV intranasal sprayers).
· Approximately 20% of the H1N1 vaccine that will be available over the course of this vaccine campaign will be in the form of the LAIV intranasal sprayer.
· The first vaccine available is in the form of LAIV intranasal sprayers.
· The first 7.5mg prefilled syringes (for children 6 months through 35 months old) are expected to be available in early November and should be available in sufficient quantity for this age group in late November.
Administration:
· Vaccine distributed at this time is intended to be used as soon as possible. Please start using this vaccine in your practice right away and consider holding clinics in your practice, especially for young children.
· Please offer H1N1 LAIV to any healthly non-pregnant patient from 2 years of age through 49 years of age.
o At this point in time, primary foci should be on 2-5 year olds that do not have any other avenue for vaccination, and caregivers and household contacts (including sibilings) of paitents younder than 6 months of age.
o It is anticipated that the focus of this H1N1 LAIV will expand soon (in ~2 weeks) to all healthy children 6 months – 18 years of age (since this is thimerasol-free vaccine).
· School vaccination clinics will be starting as soon as mid-October. Please consider requests to partner with schools to vaccinate school children.
· WEEKLY reporting of doses adimintered is due by close of business every Saturday.
o Either fax report to 207-287-8127 or submit online at http://www.maine.gov/dhhs/boh/maineflu/h1n1/hc-providers/h1n1-vaccine-weeklyreport.shtml
· Order vaccine frequently.
Maine CDC was one of few states that ordered its entire allotment of H1N1 vaccine this week. Our Immunization Program staff along with redeployed Maine CDC staff worked many hours to accomplish this. Over 300 health care providers were registered as H1N1 distribution sites. 8,700 doses of LAIV (Live Attenuated Influenza Vaccine), also known as nasal spray vaccine (analogous to the seasonal flu vaccine FluMist), will be arriving and distributed to about 70 clinical sites this coming week – most likely arriving at clinical sites Tuesday or Wednesday. We ask that these first few doses of vaccine be focused on healthy children, especially young children ages 2 – 5 years of age, and household contacts and caregivers of young infants under 6 months old. This LAIV is licensed for healthy non-pregnant 2 – 49 year olds, and as more vaccine arrives, this formulation should be expanded to include other high priority populations that fit the licensure parameters.
We expect to be able to order other formulations plus additional LAIV this coming week. As we are able to order and distribute more vaccine, the high priority populations it will be focused on will be expanded. For the next few weeks we anticipate focusing vaccine on the 5 high priority populations of:
· pregnant women;
· people ages 6 months – 25 years of age;
· household contacts and caregivers of young infants under 6 months old;
· people 25 – 65 years of age with underlying conditions; and
· health care workers including EMS.
Within the latter category of health care workers, we anticipate that this next several weeks the vaccine will most likely be focused on hospital-based health care workers with direct patient contact who work in emergency departments, intensive care units, labor and delivery units, and inpatient pediatric wards. As vaccine becomes more available, the priority groups it can reach can expand.
Our vaccine distribution and administration plans focus on settings where these high priority populations are in highest numbers and proportion. For instance, we are currently focused on distributing H1N1 vaccine to pediatric and obstetrical health care providers, hospitals, schools, and city health departments. This means that health care providers who have not been accepted by the end of this coming week as a distribution site most likely do not fit into these priority settings. If we are allowed more distribution sites, we may be able to expand to include these other health care providers. If not, H1N1 vaccine can easily be redistributed to these other health care providers from a distribution site. However, we ask that it still remain focused on high priority populations for now. Highlights from information sent to all current H1N1 vaccine distribution sites are below this email and the CDC documents.
Thank you for all the work you and many others are doing! It is exciting to think the vaccine is almost here, though I know these next few weeks will be quite busy for anyone involved with health care and public health.
Dora
2009-2010 Influenza Season Triage Algorithm for Adults (>18 Years) With Influenza-Like Illness
This algorithm is designed to assist physicians and those under their supervision in identifying indicators of and responses to symptoms of flu-like illness (i.e., fever with cough or sore throat). (NOTE: this guidance is not intended for use by the general public and is not a substitute for sound clinical judgment.)
Download and print the algorithm (PDF) >>
H1N1 Flu Vaccine Information Statements (VISs)
Vaccine Information Statements (VISs) are information sheets produced by CDC that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine.
Inactivated 2009 H1N1 Influenza Vaccine
(the flu shot)
Live, Intranasal 2009 H1N1 Influenza Vaccine
(the nasal spray vaccine)
Pregnancy and H1N1
Update: 2009 H1N1 Influenza Shots and Pregnant Women: Questions and Answers for Patients
Why does CDC advise pregnant women to receive the 2009 H1N1 influenza (flu) vaccine (shot)? Will the seasonal flu shot also protect against the 2009 H1N1 flu? Are there flu vaccines that pregnant women should not get? More...
2009 H1N1 Influenza Vaccine and Pregnant Women: Information for Healthcare Providers
Where can healthcare providers obtain 2009 H1N1 flu vaccine? How should healthcare providers organize their clinics for vaccination? How many vaccine doses will a pregnant woman need to get? More...
H1N1 Clinician Information
Update: H1N1 Clinicians Questions and Answers
The age for two doses is different for seasonal (6 months through 8 years) and 2009 H1N1 monovalent vaccine (6 months through 9 years) in the package inserts. Does CDC recommend that clinicians follow the recommendation in the package inserts? Can a person who has received LAIV test positive on a rapid influenza diagnostic test? And more...
Questions and Answers on 2009 H1N1 Vaccine Financing
Considerations of financing distinguish between those related to the vaccine itself, the ancillary supplies needed to administer the vaccine, and the actual administration of the vaccine.
Questions & Answers: Interim Recommendations for Clinical Use of Influenza Diagnostic Testing During the 2009-2010 Influenza Season - For Health Care Providers
What does CDC recommend this season regarding testing for influenza? What is the reason for these recommendations? Does CDC recommend diagnostic testing for patients with uncomplicated illness from suspected influenza infection? More...
Interim Recommendations for Clinical Use of Influenza Diagnostic Tests During the 2009-10 Influenza Season
To provide updated interim recommendations on influenza diagnostic testing for clinicians treating patients with suspected 2009 H1N1 influenza virus infection and to assist clinicians with testing decisions for the 2009-10 influenza season.
H1N1 Information for Patients
Preparing for the Flu: A Communication Toolkit for the Federal Workforce
The purpose of Preparing for the Flu: A Communication Toolkit for the Federal Workforce is to provide information and communication resources to help federal agencies and employees implement recommendations from CDC in planning and responding to the 2009–2010 Influenza Season.
2009 H1N1 Influenza Vaccine and Seniors
Questions and Answers about 2009 H1N1 Influenza Vaccine and Seniors
Questions & Answers: Influenza Diagnostic Testing During the 2009-2010 Flu Season - For the Public
How will I know if I have the flu this season? How can I know for certain if I have the flu this season? What kinds of flu tests are there? More...
HIGLIGHTS OF INFORMATION SENT BY MAINE CDC TO H1N1 VACCINE DISTRIBUTION SITES FRIDAY:
Distribution:
· We expect approximately 800,00 doses of vaccine to be available in Maine by early January 2010.
· H1N1 vaccine will be offered in four different presentations: 7.5mg prefilled syringes, 15mg prefilled syringes, multi-dose vials and intranasal sprayers (LAIV).
· Approximately 40% of the vaccine will be in thimerosal free presentations (prefilled syringes and LAIV intranasal sprayers).
· Approximately 20% of the H1N1 vaccine that will be available over the course of this vaccine campaign will be in the form of the LAIV intranasal sprayer.
· The first vaccine available is in the form of LAIV intranasal sprayers.
· The first 7.5mg prefilled syringes (for children 6 months through 35 months old) are expected to be available in early November and should be available in sufficient quantity for this age group in late November.
Administration:
· Vaccine distributed at this time is intended to be used as soon as possible. Please start using this vaccine in your practice right away and consider holding clinics in your practice, especially for young children.
· Please offer H1N1 LAIV to any healthly non-pregnant patient from 2 years of age through 49 years of age.
o At this point in time, primary foci should be on 2-5 year olds that do not have any other avenue for vaccination, and caregivers and household contacts (including sibilings) of paitents younder than 6 months of age.
o It is anticipated that the focus of this H1N1 LAIV will expand soon (in ~2 weeks) to all healthy children 6 months – 18 years of age (since this is thimerasol-free vaccine).
· School vaccination clinics will be starting as soon as mid-October. Please consider requests to partner with schools to vaccinate school children.
· WEEKLY reporting of doses adimintered is due by close of business every Saturday.
o Either fax report to 207-287-8127 or submit online at http://www.maine.gov/dhhs/boh/maineflu/h1n1/hc-providers/h1n1-vaccine-weeklyreport.shtml
· Order vaccine frequently.
UK used only 5% of the H1N1 vaccine originally ordered/ BBC
The UK government originally contracted for 120 million doses of swine flu vaccine; it was able to cancel some contracts (by agreeing to buy bird flu vaccine for an epidemic that does not exist, and buying extra flu drugs from GSK), but still purchased 44 million doses.
Only 6 million doses were actually used. The total cost of the swine flu vaccine procurement was not stated, but probably approaches a billion dollars. (Neither the UK government nor the manufacturers will divulge the actual price.) According to Business Week and the Independent:
Only 6 million doses were actually used. The total cost of the swine flu vaccine procurement was not stated, but probably approaches a billion dollars. (Neither the UK government nor the manufacturers will divulge the actual price.) According to Business Week and the Independent:
GSK is in talks with a number of other administrations over plans to par back vaccine orders. A host of northern hemisphere countries are known to want to slash orders after the initial spike in incidents of swine flu cases quickly tailed off. Among them, France, Belgium and Spain are thought to be in talks with GSK.
The company said that it would not be altering its earnings estimates for 2010, saying that it expects to see swine flu vaccine sales of about £880m this year, a similar amount to 2009.
Weekly Update on H1N1 in Maine October 1, 2009
Overview
US CDC reports that flu activity continued to increase in the US during the week of Sept. 13-19. Widespread influenza activity continues in much of the southern parts of the country, including higher than expected hospitalizations for this time of year. Outpatient visits for influenza like illness (ILI) increased in much of New England.
In Maine, visits to outpatient office settings and hospital emergency departments for influenza like illness increased this past week. There have been some occasional cases of H1N1 detected in students, but no new distinct outbreaks have been identified this past week.
However, the increases in outpatient visits and students indicate that this is the time to be extra vigilant in respiratory precautions, especially staying away from work and school when one has a fever, properly covering coughs and sneezes, and washing hands frequently. Recommendations for schools can be found in the “Quick Reference Guide” at: http://www.maine.gov/dhhs/boh/maineflu/h1n1/educators.shtml. Guidance for other settings (child care, businesses, etc) can be found at www.maineflu.gov.
There continue to be delays in Maine receiving seasonal influenza vaccine, especially pediatric influenza vaccine for large scale clinics. We expect this vaccine to arrive in late October. Schools and other settings that have planned large scale clinics with this vaccine should postpone these clinics until early November if they have not yet received vaccine. They should be able to offer H1N1 vaccine concurrently at these clinics.
Maine CDC placed the first orders for H1N1 vaccine on Wednesday September 30th. The first orders should arrive next week and are for a small amount of live attenuated intranasal vaccine (LAIV) shipped primarily to pediatric health care providers for healthy toddlers and household contacts and caregivers of young infants. We are placing additional orders for this vaccine this week, and anticipate being able to place orders for other formulations of the H1N1 vaccine next week. It is important that health care providers who want to have H1N1 vaccine shipped directly to them register as an H1N1 provider and place orders as soon as possible. For more information see the section for health care providers at: www.maineflu.gov.
Seasonal influenza vaccine
Maine CDC has distributed about than 121,000 doses of seasonal flu vaccine, with most of this (80,000) going to pediatric providers and schools. Approximately 15 schools or school districts have held vaccine clinics. Due to nationwide delays in distribution of seasonal flu vaccine, Maine CDC recommended last week that large public clinics and school-located clinics be rescheduled if vaccine for those clinics had not already arrived. Clinic planners are advised to reschedule to early November, and to consider offering both seasonal flu vaccine and H1N1 flu vaccine at the same time.
H1N1 influenza vaccine
Maine CDC has placed its first orders with U.S. CDC for the first shipments of H1N1 vaccine this week, starting Wednesday, September 30th. The first shipments are not expected to arrive until the week of October 5th and will consist of only a limited number (~7,700) of one type of H1N1 vaccine, the H1N1 LAIV (Live Attenuated Intranasal Vaccine). This nasal formulation’s license is limited to healthy non-pregnant 2 – 49 year olds. In terms of the high-risk populations for H1N1, this vaccine is most appropriate for healthy children (especially those under 5 since they are at higher risk for H1N1 complications than older children) and household contacts of young infants. Maine CDC urges pediatric and obstetrical health care providers to register and submit orders for H1N1 vaccine as soon as possible.
If you are a licensed health care provider for children or their families, and have not registered as an H1N1 Provider, then please do so now. You must register even if you already receive vaccine from Maine CDC. To register, fill out and submit the H1N1 Provider Agreement for H1N1 Vaccine, which can be found at www.maineflu.gov.
If you have registered and have received ordering information, please submit your order as soon as possible to Maine CDC. We cannot ship vaccine to you unless you have submitted an order.
· For questions regarding H1N1 influenza vaccine ordering see the FAQ from the September 17th health advisory (http://www.maine.gov/tools/whatsnew/attach.php?id=79438&an=2)
· For other questions:
Contact the Maine CDC’s Immunization Program at 287-3746 or the public information line at 1-888-257-0990.
Email us questions at: flu.questions@maine.gov
More information, including consent forms and billing information, will be found at www.maineflu.gov
Updated CDC guidance on H1N1 influenza vaccine including vaccine handling can be found at: http://www.cdc.gov/h1n1flu/vaccination
FAQ on H1N1 vaccine safety can be found at: http://www.cdc.gov/h1n1flu/vaccination/vaccine_safety_qa.htm
FAQs Related to H1N1 Vaccine (more detailed answers can be found at www.maineflu.gov):
Can seasonal influenza vaccine and H1N1 vaccine be given at the same visit?
Yes. However, both the nasal forms of the vaccine cannot be given at the same time. If both the nasal forms are to be given, then they should be separate by a minimum of 4 weeks. The injectable forms of the seasonal and H1N1 vaccine can be given at the same time (different anatomical locations), and a nasal vaccine of one and an injectable vaccine of the other can be given at the same time.
Can H1N1 vaccine be administered at the same visit as other vaccines?
Inactivated H1N1 vaccine can be administered at the same visit as any other vaccine, including pneumococcal polysaccharide vaccine. Live H1N1 vaccine can be administered at the same visit as any other live or inactivated vaccine EXCEPT seasonal live attenuated influenza vaccine.
Will the H1N1 vaccine be recommended for patients who had influenza-like illness since spring 2009?
Yes.
Does the H1N1 vaccine contain adjuvants such as squalene or aluminum?
No.
Is the H1N1 vaccine mandatory?
No.
Does the H1N1 vaccine contain thimerosal?
The multi-dose vials of H1N1 vaccine contain a very small amount of thimerosal in order to prevent bacterial contamination. The single-dose syringes and nasal spray do not contain thimerosal. These thimerosal-free formulations are expected to represent about one-third of the H1N1 vaccine supply distributed in the next 3 months. This thimerosal-free vaccine is primarily being distributed to settings where pregnant women and young children are offered vaccine.
Who are the priority populations for H1N1 vaccine these first few weeks?
Pregnant women, all children and young adults ages 6 months to 25 years old, caregivers and household contacts of infants under 6 months, 25 – 65 year olds with underlying conditions, and health care workers including EMS.
Why does the seasonal flu vaccine list “H1N1” on it but does not protect against the H1N1 pandemic?
The seasonal flu vaccine protects against three major strains of influenza virus, including a seasonal (“regular”) strain of H1N1 influenza. However, protection against this seasonal strain of H1N1 does not protect you against the 2009 pandemic strain of H1N1.
Other New or Recently Updated H1N1 Guidance or News
US CDC posted the following materials on its web site:
· CDC announced the approval this week of H1N1 Vaccines. An FDA press release may be viewed at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm
· Updated Questions & Answers: Antiviral Drugs, 2009-2010 Flu Season is available at http://www.cdc.gov/h1n1flu/antiviral.htm.
· Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season was issued earlier this week and can be found at http://www.cdc.gov/h1n1flu/recommendations.htm.
· 2009-2010 Influenza Season: Information for Pharmacists is available at http://www.cdc.gov/H1N1flu/pharmacist/pharmacist_info.htm. This document provides 1.) background information on influenza activity to date and how pharmacists may be affected this season, 2.) an update on antiviral drug supplies, 3.) information about compounding an oral suspension from Tamiflu® 75mg capsules and 4.) information about the oral dosing dispenser provided with certain formulations of Tamiflu® oral suspension.
· Updated Interim Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season is now posted at http://www.cdc.gov/H1N1flu/pregnancy/antiviral_messages.htm.
· Asthma Information for Patients and Parents of Patients is now posted at http://www.cdc.gov/H1N1flu/asthma.htm.
· Brochure 2009 H1N1 and You is posted at http://www.cdc.gov/h1n1flu/flyers.htm.
How to Stay Updated
Weekly Updates: Check the Thursday morning updates on H1N1 in Maine on Maine CDC’s H1N1 website. Now available as an RSS feed (midway down the center of the homepage): http://www.maineflu.gov/
Health Alert Network: Sign up to receive urgent updates from Maine CDC’s Health Alert Network (HAN). The easiest and quickest way is to sign up is through the HAN Alert RSS feed at www.mainepublichealth.gov (midway down the center of the homepage).
Follow Maine CDC’s Updates:
Facebook (search for “Maine CDC”)
Twitter (http://twitter.com/MEPublicHealth)
MySpace (www.myspace.com/mainepublichealth)
Maine CDC’s Blog (http://mainepublichealth.blogspot.com)
H1N1 Conference Calls: Maine CDC will be holding conference calls on a variety of topics related to H1N1 over the coming weeks. The next call will be held Monday, October 5, from noon to 1pm, to update interested stakeholders on H1N1 vaccine efforts. To participate, call 1-800-914-3396 and enter pass code 473623#.
Call or Email Us:
For clinical consultation, outbreak management guidance, and reporting of an outbreak of H1N1 call Maine CDC’s toll free 24-hour phone line at: 1-800-821-5821.
General Public Call-in Number for Questions: 1-888-257-0990NextTalk (deaf/hard of hearing) - (207) 629-5751Monday - Friday 9 a.m. – 5 p.m.
Email your questions to: flu.questions@maine.gov
U.S. CDC H1N1 Recommendations and Guidance: http://www.cdc.gov/h1n1flu/ and http://www.flu.gov/
US CDC reports that flu activity continued to increase in the US during the week of Sept. 13-19. Widespread influenza activity continues in much of the southern parts of the country, including higher than expected hospitalizations for this time of year. Outpatient visits for influenza like illness (ILI) increased in much of New England.
In Maine, visits to outpatient office settings and hospital emergency departments for influenza like illness increased this past week. There have been some occasional cases of H1N1 detected in students, but no new distinct outbreaks have been identified this past week.
However, the increases in outpatient visits and students indicate that this is the time to be extra vigilant in respiratory precautions, especially staying away from work and school when one has a fever, properly covering coughs and sneezes, and washing hands frequently. Recommendations for schools can be found in the “Quick Reference Guide” at: http://www.maine.gov/dhhs/boh/maineflu/h1n1/educators.shtml. Guidance for other settings (child care, businesses, etc) can be found at www.maineflu.gov.
There continue to be delays in Maine receiving seasonal influenza vaccine, especially pediatric influenza vaccine for large scale clinics. We expect this vaccine to arrive in late October. Schools and other settings that have planned large scale clinics with this vaccine should postpone these clinics until early November if they have not yet received vaccine. They should be able to offer H1N1 vaccine concurrently at these clinics.
Maine CDC placed the first orders for H1N1 vaccine on Wednesday September 30th. The first orders should arrive next week and are for a small amount of live attenuated intranasal vaccine (LAIV) shipped primarily to pediatric health care providers for healthy toddlers and household contacts and caregivers of young infants. We are placing additional orders for this vaccine this week, and anticipate being able to place orders for other formulations of the H1N1 vaccine next week. It is important that health care providers who want to have H1N1 vaccine shipped directly to them register as an H1N1 provider and place orders as soon as possible. For more information see the section for health care providers at: www.maineflu.gov.
Seasonal influenza vaccine
Maine CDC has distributed about than 121,000 doses of seasonal flu vaccine, with most of this (80,000) going to pediatric providers and schools. Approximately 15 schools or school districts have held vaccine clinics. Due to nationwide delays in distribution of seasonal flu vaccine, Maine CDC recommended last week that large public clinics and school-located clinics be rescheduled if vaccine for those clinics had not already arrived. Clinic planners are advised to reschedule to early November, and to consider offering both seasonal flu vaccine and H1N1 flu vaccine at the same time.
H1N1 influenza vaccine
Maine CDC has placed its first orders with U.S. CDC for the first shipments of H1N1 vaccine this week, starting Wednesday, September 30th. The first shipments are not expected to arrive until the week of October 5th and will consist of only a limited number (~7,700) of one type of H1N1 vaccine, the H1N1 LAIV (Live Attenuated Intranasal Vaccine). This nasal formulation’s license is limited to healthy non-pregnant 2 – 49 year olds. In terms of the high-risk populations for H1N1, this vaccine is most appropriate for healthy children (especially those under 5 since they are at higher risk for H1N1 complications than older children) and household contacts of young infants. Maine CDC urges pediatric and obstetrical health care providers to register and submit orders for H1N1 vaccine as soon as possible.
If you are a licensed health care provider for children or their families, and have not registered as an H1N1 Provider, then please do so now. You must register even if you already receive vaccine from Maine CDC. To register, fill out and submit the H1N1 Provider Agreement for H1N1 Vaccine, which can be found at www.maineflu.gov.
If you have registered and have received ordering information, please submit your order as soon as possible to Maine CDC. We cannot ship vaccine to you unless you have submitted an order.
· For questions regarding H1N1 influenza vaccine ordering see the FAQ from the September 17th health advisory (http://www.maine.gov/tools/whatsnew/attach.php?id=79438&an=2)
· For other questions:
Contact the Maine CDC’s Immunization Program at 287-3746 or the public information line at 1-888-257-0990.
Email us questions at: flu.questions@maine.gov
More information, including consent forms and billing information, will be found at www.maineflu.gov
Updated CDC guidance on H1N1 influenza vaccine including vaccine handling can be found at: http://www.cdc.gov/h1n1flu/vaccination
FAQ on H1N1 vaccine safety can be found at: http://www.cdc.gov/h1n1flu/vaccination/vaccine_safety_qa.htm
FAQs Related to H1N1 Vaccine (more detailed answers can be found at www.maineflu.gov):
Can seasonal influenza vaccine and H1N1 vaccine be given at the same visit?
Yes. However, both the nasal forms of the vaccine cannot be given at the same time. If both the nasal forms are to be given, then they should be separate by a minimum of 4 weeks. The injectable forms of the seasonal and H1N1 vaccine can be given at the same time (different anatomical locations), and a nasal vaccine of one and an injectable vaccine of the other can be given at the same time.
Can H1N1 vaccine be administered at the same visit as other vaccines?
Inactivated H1N1 vaccine can be administered at the same visit as any other vaccine, including pneumococcal polysaccharide vaccine. Live H1N1 vaccine can be administered at the same visit as any other live or inactivated vaccine EXCEPT seasonal live attenuated influenza vaccine.
Will the H1N1 vaccine be recommended for patients who had influenza-like illness since spring 2009?
Yes.
Does the H1N1 vaccine contain adjuvants such as squalene or aluminum?
No.
Is the H1N1 vaccine mandatory?
No.
Does the H1N1 vaccine contain thimerosal?
The multi-dose vials of H1N1 vaccine contain a very small amount of thimerosal in order to prevent bacterial contamination. The single-dose syringes and nasal spray do not contain thimerosal. These thimerosal-free formulations are expected to represent about one-third of the H1N1 vaccine supply distributed in the next 3 months. This thimerosal-free vaccine is primarily being distributed to settings where pregnant women and young children are offered vaccine.
Who are the priority populations for H1N1 vaccine these first few weeks?
Pregnant women, all children and young adults ages 6 months to 25 years old, caregivers and household contacts of infants under 6 months, 25 – 65 year olds with underlying conditions, and health care workers including EMS.
Why does the seasonal flu vaccine list “H1N1” on it but does not protect against the H1N1 pandemic?
The seasonal flu vaccine protects against three major strains of influenza virus, including a seasonal (“regular”) strain of H1N1 influenza. However, protection against this seasonal strain of H1N1 does not protect you against the 2009 pandemic strain of H1N1.
Other New or Recently Updated H1N1 Guidance or News
US CDC posted the following materials on its web site:
· CDC announced the approval this week of H1N1 Vaccines. An FDA press release may be viewed at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm
· Updated Questions & Answers: Antiviral Drugs, 2009-2010 Flu Season is available at http://www.cdc.gov/h1n1flu/antiviral.htm.
· Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season was issued earlier this week and can be found at http://www.cdc.gov/h1n1flu/recommendations.htm.
· 2009-2010 Influenza Season: Information for Pharmacists is available at http://www.cdc.gov/H1N1flu/pharmacist/pharmacist_info.htm. This document provides 1.) background information on influenza activity to date and how pharmacists may be affected this season, 2.) an update on antiviral drug supplies, 3.) information about compounding an oral suspension from Tamiflu® 75mg capsules and 4.) information about the oral dosing dispenser provided with certain formulations of Tamiflu® oral suspension.
· Updated Interim Recommendations for Obstetric Health Care Providers Related to Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season is now posted at http://www.cdc.gov/H1N1flu/pregnancy/antiviral_messages.htm.
· Asthma Information for Patients and Parents of Patients is now posted at http://www.cdc.gov/H1N1flu/asthma.htm.
· Brochure 2009 H1N1 and You is posted at http://www.cdc.gov/h1n1flu/flyers.htm.
How to Stay Updated
Weekly Updates: Check the Thursday morning updates on H1N1 in Maine on Maine CDC’s H1N1 website. Now available as an RSS feed (midway down the center of the homepage): http://www.maineflu.gov/
Health Alert Network: Sign up to receive urgent updates from Maine CDC’s Health Alert Network (HAN). The easiest and quickest way is to sign up is through the HAN Alert RSS feed at www.mainepublichealth.gov (midway down the center of the homepage).
Follow Maine CDC’s Updates:
Facebook (search for “Maine CDC”)
Twitter (http://twitter.com/MEPublicHealth)
MySpace (www.myspace.com/mainepublichealth)
Maine CDC’s Blog (http://mainepublichealth.blogspot.com)
H1N1 Conference Calls: Maine CDC will be holding conference calls on a variety of topics related to H1N1 over the coming weeks. The next call will be held Monday, October 5, from noon to 1pm, to update interested stakeholders on H1N1 vaccine efforts. To participate, call 1-800-914-3396 and enter pass code 473623#.
Call or Email Us:
For clinical consultation, outbreak management guidance, and reporting of an outbreak of H1N1 call Maine CDC’s toll free 24-hour phone line at: 1-800-821-5821.
General Public Call-in Number for Questions: 1-888-257-0990NextTalk (deaf/hard of hearing) - (207) 629-5751Monday - Friday 9 a.m. – 5 p.m.
Email your questions to: flu.questions@maine.gov
U.S. CDC H1N1 Recommendations and Guidance: http://www.cdc.gov/h1n1flu/ and http://www.flu.gov/
Large Mumps Outbreak Ongoing in Vaccinated Hasidic Jews
Snippets from Business Week. One solution being used in Orange County is to keep vaccinating with a third dose of the same vaccine, though the MMWR editor notes that no data exist to support this approach. Isn't the appropriate answer to develop a better vaccine?
According to the MMWR, "Among patients aged 7–18 years, the age group with the majority of cases and for whom 2 doses of MMR vaccine is recommended, 93% had received at least 1 dose, and 85% had received 2 doses."
According to the MMWR, "Among patients aged 7–18 years, the age group with the majority of cases and for whom 2 doses of MMR vaccine is recommended, 93% had received at least 1 dose, and 85% had received 2 doses."
A study released Thursday by the U.S. Centers for Disease Control and Prevention tracked an ongoing outbreak of mumps, largely confined to an orthodox Hasidic Jewish group. The outbreak started among boys attending a religious summer camp in New York State and continued when the youngsters returned to their homes in New York and New Jersey. Currently some 1,521 cases have been reported, with more individuals coming down with the disease."The outbreak has been ongoing since the end of June," said study co-author and CDC epidemiologist Kathleen Gallagher. "Ninety-seven percent of cases are among this Jewish community."
Most of the people who have become sick had received the mumps, measles and rubella vaccine (MMR), according to the report. In fact, 88 percent had received at least one dose of the vaccine and 75 percent had received two doses.
Outbreaks of mumps are not all that unusual, Gallagher said. "We have had outbreaks of mumps in communities that have had two doses before," she said.
Universal Childhood Immunization Program
LD 1408, An Act to Establish the Universal Childhood Immunization Program, has passed both chambers of the state Legislature and been signed into law by the Governor.
The program provides universal immunization coverage to children in the state by purchasing and making available to health care providers every vaccine for childhood immunization that is recommended by the US CDC’s Advisory Committee on Immunization Practices, approved by the FDA, and available under contract with US CDC.
For more information on this legislation, visit: http://mainelegislature.org/legis/bills/display_ps.asp?paper=HP0984&snum=124
Thank you to the many stakeholders who worked on this bill for 4 years, and to the bill’s sponsor, Representative Connor! Updates on the bill’s implementation, including timelines, will be forthcoming.
The program provides universal immunization coverage to children in the state by purchasing and making available to health care providers every vaccine for childhood immunization that is recommended by the US CDC’s Advisory Committee on Immunization Practices, approved by the FDA, and available under contract with US CDC.
For more information on this legislation, visit: http://mainelegislature.org/legis/bills/display_ps.asp?paper=HP0984&snum=124
Thank you to the many stakeholders who worked on this bill for 4 years, and to the bill’s sponsor, Representative Connor! Updates on the bill’s implementation, including timelines, will be forthcoming.
Don't give children flu jab: chief medical officer/ Sydney Morning Herald
Australia's chief medical officer halted seasonal flu vaccinations for children under five, due to a high number of children in Western Australia experiencing fever and convulsions after the shot. This will give the country time to ascertain whether the problem is due to "bad batches" or whether the makeup of the immunization itself is the problem. The swine flu vaccine will continue to be used; it is the seasonal vaccine that appears to cause the problem. New Zealand has followed suit and stopped vaccinations in the under-5 age group.
Kudos to Australia's public health system and chief medical officer for a perfect response:
An healthy two year old girl died in Queensland 12 hours after receiving her seasonal flu vaccine, on April 9.
Kudos to Australia's public health system and chief medical officer for a perfect response:
- acknowledging the problem,
- halting vaccinations pending results of its investigation,
- enhancing surveillance for adverse events (even asking parents to report adverse events),
- consulting with colleagues internationally, and
- conducting its own investigation.
An healthy two year old girl died in Queensland 12 hours after receiving her seasonal flu vaccine, on April 9.
Professor Collignon says health authorities need to better weigh up whether rolling out a vaccination to millions of people around the country will cause more harm than good.
"If you're in a risk group everybody agrees you need to be vaccinated," he said. "But the majority of the population don't have risk factors, including children, and before we roll out a vaccine to millions of people, in my view, we need to do studies of thousands of people over a period of time to make sure we are always going to do more good than harm with the vaccine."
Professor Collignon says about 20 per cent of Australian children who received the swine flu vaccine had moderate to severe side effects in the form of a fever of more than 38.5 degrees Celsius and severe muscle aches and pains.
But he says last winter, the risk of someone under the age of 40 getting swine flu and dying from it was less than one in a million.
"You have to start weighing this up because you may actually produce as much influenza-like illness with a vaccine as you prevent with people not getting influenza," he said... [When I had a private practice, it was my impression that about 20% of elderly flu vaccine recipients told me that they developed a flu-like illness shortly after receiving the vaccine--Nass]
Professor Collignon says an effective surveillance system should monitor thousands of people for one or two weeks after vaccination before rolling out the vaccine to the entire population... [This is absolutely what is needed for all vaccines. But surveillance should be carried out over longer periods as well, since a different set of adverse reactions may occur later.--Nass]UPDATE April 26: Vaccinating small children against influenza is a new idea, and in the US was based on the (unproven) theory that vaccinating children will prevent their grandparents from getting flu. The 2009-10 swine flu epidemic was the first to provide policymakers with a better rationale for vaccinating children: to protect children. However, even for swine flu, the number of deaths in otherwise healthy children was quite small. (To estimate total US child deaths, CDC quadrupled the number of known child deaths. This strategy assumed that public health officials missed counting 75% of children who died. However, virtually all child deaths occur in hospitals and were therefore counted, making the CDC strategy specious.)
Last October, Rino Rappuoli, MD (the head of Novartis Vaccines in Siena, Italy) wrote in Science magazine that, "At present, only the United States, Finland, and Mexico recommend vaccination of children, and implementation is low." [Public health. Rethinking influenza. Rappuoli R, Del Giudice G, Nabel GJ, Osterhaus AD, Robinson R, Salisbury D, Stöhr K, Treanor JJ. Science. 2009 Oct 2;326(5949):50.] Thus there was little experience with mass flu vaccination of young children before now.
IMHO, the world's public health policymakers have jumped on the flu vaccines for children bandwagon with very little data on the risks and benefits, taking their cue from swine flu. But influenza vaccines are made up differently each year, in a rush to be available before the winter flu season, and are therefore not tested in humans prior to use. Whether children actually get more benefit than harm from such vaccines remains to be seen. For flu seasons 2005-6 through 2008-9, less than 100 children died per season in the US from influenza. Most had chronic health problems, and would have been in a high-risk group for whom vaccination is appropriate. But is it appropriate for the rest of our children?
WHO Director Chan begins instilling fear of bird flu/ BBC
You read it here first on October 25: bird flu vaccinations may be next.
Dr Margaret Chan says avian flu is more of a problem than swine fluThe head of the World Health Organisation (WHO) has warned the global swine flu pandemic is not yet over and the virus could still mutate....
However she admitted she had not yet had a vaccine but said she would have it soon.
She said that although countries are now better prepared to cope with a global disease outbreak, people still had to be aware of the dangers of bird flu (H5N1).
She said this was more toxic and deadly than swine flu and that many countries remained ill-prepared for mass outbreaks of this virus.
"The world is not ready for a pandemic to be caused by H5N1," she said.
And old bird flu vaccine trial data were substituted to license European swine flu vaccines (a neat way to distribute swine flu vaccine before there is any data on it).
Might the 97 partnerships and collaborative arrangements with WHO, which supply about 80% of WHO's budget, or simply channeling money have influenced the way WHO weakened the criteria for a pandemic last spring, and/or influenced WHO's support for billions of doses of unnecessary vaccine for swine flu?
Swiss warn on flu vaccine with autoimmune disease/ Reuters
ZURICH (from Jan. 20, 2010: Reuters) -
Switzerland's medical regulator recommended patients with serious
autoimmune diseases should not use an H1N1 flu vaccine from
Novartis, saying there were no studies assessing the innoculation in that
population.
Swissmedic said on Wednesday it could not be ruled out that either or both
the adjuvant -- which can enhance the immune response -- and/or the antigen, or less active ingredient, could lead to an intensifying of autoimmune diseases.Autoimmune diseases, like rheumatoid arthritis, are caused by an overly
active immune system attacking its own body, targeting substances which are
normally present.
Novartis was not immediately available to comment.
Instead, Novartis was busy flogging its MF59 adjuvant in the US for BIRD FLU. The only problem is that enhanced immune responses are dangerous in people who have autoimmune diseases, or a genetic predisposition to them. And from another of today's Reuters articles:
A vaccine additive made by Novartis (NOVN.VX) and used in its European influenza shots can boost the body's immune response to a wide range of viruses, U.S. researchers reported on Wednesday.
Tests in the laboratory suggested the so-called adjuvant, called MF59, helped the immune system counteract not only the H5N1 virus in the current experimental bird flu vaccine, but mutant viruses as well. The U.S. Food and Drug Administration study, published in the journal Science Translational Medicine, suggests using vaccines with adjuvants may protect patients against even more types of flu viruses than they are being vaccinated against. Adjuvants are widely used in European flu vaccines as well as in Canada. But are not widely used in the United States -- even though the federal government has spent nearly $700 million buying them.
The reason? People might not trust them.
Other studies have shown adjuvants can stretch the supply of flu vaccine, because
shots using them require much less of the actual vaccine antigen."Adjuvanted vaccines produce higher immune response than unadjuvanted vaccines particularly in the elderly and young children," Dr. Vas Narasimhan, president of Novartis Vaccines USA, told a U.S. Congressional hearing last November.
Don't give children flu jab: chief medical officer/ Sydney Morning Herald
Australia's chief medical officer halted seasonal flu vaccinations for children under five, due to a high number of children in Western Australia experiencing fever and convulsions after the shot. This will give the country time to ascertain whether the problem is due to "bad batches" or whether the makeup of the immunization itself is the problem. The swine flu vaccine will continue to be used; it is the seasonal vaccine that appears to cause the problem. New Zealand has followed suit and stopped vaccinations in the under-5 age group.
Kudos to Australia's public health system and chief medical officer for a perfect response:
An healthy two year old girl died in Queensland 12 hours after receiving her seasonal flu vaccine, on April 9.
Kudos to Australia's public health system and chief medical officer for a perfect response:
- acknowledging the problem,
- halting vaccinations pending results of its investigation,
- enhancing surveillance for adverse events (even asking parents to report adverse events),
- consulting with colleagues internationally, and
- conducting its own investigation.
An healthy two year old girl died in Queensland 12 hours after receiving her seasonal flu vaccine, on April 9.
Professor Collignon says health authorities need to better weigh up whether rolling out a vaccination to millions of people around the country will cause more harm than good.
"If you're in a risk group everybody agrees you need to be vaccinated," he said. "But the majority of the population don't have risk factors, including children, and before we roll out a vaccine to millions of people, in my view, we need to do studies of thousands of people over a period of time to make sure we are always going to do more good than harm with the vaccine."
Professor Collignon says about 20 per cent of Australian children who received the swine flu vaccine had moderate to severe side effects in the form of a fever of more than 38.5 degrees Celsius and severe muscle aches and pains.
But he says last winter, the risk of someone under the age of 40 getting swine flu and dying from it was less than one in a million.
"You have to start weighing this up because you may actually produce as much influenza-like illness with a vaccine as you prevent with people not getting influenza," he said... [When I had a private practice, it was my impression that about 20% of elderly flu vaccine recipients told me that they developed a flu-like illness shortly after receiving the vaccine--Nass]
Professor Collignon says an effective surveillance system should monitor thousands of people for one or two weeks after vaccination before rolling out the vaccine to the entire population... [This is absolutely what is needed for all vaccines. But surveillance should be carried out over longer periods as well, since a different set of adverse reactions may occur later.--Nass]UPDATE April 26: Vaccinating small children against influenza is a new idea, and in the US was based on the (unproven) theory that vaccinating children will prevent their grandparents from getting flu. The 2009-10 swine flu epidemic was the first to provide policymakers with a better rationale for vaccinating children: to protect children. However, even for swine flu, the number of deaths in otherwise healthy children was quite small. (To estimate total US child deaths, CDC quadrupled the number of known child deaths. This strategy assumed that public health officials missed counting 75% of children who died. However, virtually all child deaths occur in hospitals and were therefore counted, making the CDC strategy specious.)
Last October, Rino Rappuoli, MD (the head of Novartis Vaccines in Siena, Italy) wrote in Science magazine that, "At present, only the United States, Finland, and Mexico recommend vaccination of children, and implementation is low." [Public health. Rethinking influenza. Rappuoli R, Del Giudice G, Nabel GJ, Osterhaus AD, Robinson R, Salisbury D, Stöhr K, Treanor JJ. Science. 2009 Oct 2;326(5949):50.] Thus there was little experience with mass flu vaccination of young children before now.
IMHO, the world's public health policymakers have jumped on the flu vaccines for children bandwagon with very little data on the risks and benefits, taking their cue from swine flu. But influenza vaccines are made up differently each year, in a rush to be available before the winter flu season, and are therefore not tested in humans prior to use. Whether children actually get more benefit than harm from such vaccines remains to be seen. For flu seasons 2005-6 through 2008-9, less than 100 children died per season in the US from influenza. Most had chronic health problems, and would have been in a high-risk group for whom vaccination is appropriate. But is it appropriate for the rest of our children?
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