Effectiveness of Flu Shots Wildly Overestimated

October 2005

“What you see is that marketing rules the response to influenza, and scientific evidence comes fourth or fifth.”(1) People should ask whether it’s worth investing these trillions of dollars and euros in these vaccines.” (2)

While the public endures an intensifying barrage of flu shot propaganda and dire predictions of an avian flu pandemic, health officials stay tight lipped about basic facts you need to know to make an informed decision before submitting to the flu vaccine.

Every year, laboratory tests conducted across Canada and compiled by Health Canada’s FluWatch, consistently show that the majority of cases of influenza like illnesses” (ILI) involve pathogens other than the influenza virus. In other words, the influenza virus is NOT the cause of most of the flu like illnesses commonly occurring during flu season.

FluWatch reports that Between 22 August, 2004 and 12 March, 2005, a total of 68,849 laboratory tests for influenza were reported of which10,319 tested positive for influenza. That is, only 14.9% of the specimens tested showed evidence of influenza viruses. (3) The remainder of these laboratory tested cases of “influenza-like-illnesses” (85.1%), (3) involved other pathogens against which influenza vaccines offer NO protection whatsoever. The majority of “influenza-like-illnesses” are NOT caused by influenza viruses and are impervious to flu vaccines.

What health officials also don’t tell you is that their claims of vaccine effectiveness are based on a misleading measure – the ability of the vaccine to produce antibodies against the virus. It is well known in immunology that circulating antibodies are not necessarily a measure of immunity from disease.

In a flu vaccine debate published in the Canadian Medical Association Journal about the effectiveness of the mass influenza vaccination program in Ontario, Italian epidemiologist, Dr. Demicheli refutes the 70%- 90% claims of vaccine efficacy, saying this is “both wrong and misleading……and refers only to the ability of the vaccine to produce antibodies effective against the virus. But this is not the important measure of vaccine efficacy. Instead, we should measure the ability of the vaccine to prevent clinical disease, in this case influenza. By this measure, vaccine efficacy is no greater than 25%.” (4)

Dr. Demicheli also affirmed that “The actual proportion of influenza A and B cases among ILI cases is not well known, but the few available studies indicate a modest proportion of probably less than 10%, regardless of age group.” (5)

In 2000 the Ontario Minister of Health and Long-Term Care launched a $38 million (annually) universal influenza immunization program for Ontario, Canada. Its objective was to decrease the seasonal impact of influenza on emergency department (ED) visits and to decrease the number and severity of influenza cases. A review of the efficacy of this program published in the Canadian Journal of Emergency Medicine found that the percentage of acute upper respiratory illnesses seeking emergency medical help is very low – “only 4.4% and of these influenza accounted for only 0.34%”. Conclusion: “Based on this study, a universal influenza immunization campaign is unlikely to affect ED volume.” (6)

On September 21, 2005 a New York Times article reported that “Just as governments around the world are stockpiling millions of doses of flu vaccine and antiviral drugs in anticipation of a potential influenza pandemic, two new research papers published today have found that such treatments are far less effective than previously thought.” (1)

The first meta-analysis was done by the Cochrane Vaccines Field, a group of scientist who looked at the results of 64 international flu vaccine studies. Their findings are published online at The Lancet, a leading British medical journal. (7)

“There is a wild overestimation of the impact of these vaccines in the community,” says Dr. Tom Jefferson, an epidemiologist in Rome who led the analysis for the Cochrane Collaboration, an independent international effort that evaluates the efficacy of medical care and performs systematic reviews of research data. (7)

Jefferson’s team analyzed patient studies on the flu vaccine performed worldwide in the past 37 years and discovered that vaccines showed at best a “modest” ability to prevent influenza or its complications in elderly people. “The runaway 100 percent effectiveness that’s touted by proponents was nowhere to be seen,” said Dr .Jefferson.”It is assumed to be 70, 80 or 90 per cent in the elderly,” Jefferson said, but the study shows “it’s not as effective… That needs to be clearly presented to our customers, not fudged.” (8)

The researchers found that flu shots were only 27 per cent effective in reducing the chance of an elderly person ending up in a hospital with influenza or pneumonia. The findings are similar to those of a previous study done by the U.S. National Institutes of Health which reviewed three decades of U.S. data. Published in the February 14, 2005 Archives of Internal Medicine, the study found that flu shots for the elderly in the United States had not saved any lives. (8)

“In the case of a pandemic, we are unsure from the data whether these vaccines would work on the elderly. Vaccines may be less effective in older people because their immune systems are less able to mount a vigorous response”, Jefferson and others said. (1, 2)

“People should ask whether it’s worth investing these trillions of dollars and euros in these vaccines,” Jefferson said. “What you see is that marketing rules the response to influenza, and scientific evidence comes fourth or fifth,” (2, 1) “The best strategy to prevent the illness is to wash your hands.” said Dr. Jefferson. (1)

For several years, health officials in Canada and the U.S. have been urging parents to vaccinate their babies age 6 to 23 months with flu vaccine. Infants and young children receive two shots 30 days apart.

Dr. Jefferson’s team also reviewed 25 studies that looked at the impact of vaccines on the number of cases of influenza and its symptoms in children up to 16. The Cochrane team concluded that there is no evidence that vaccinating children under 2 years old against influenza reduces deaths or complications from the illness. (9, 10)

“Immunization of very young children is not lent support by our findings,” said Dr Tom Jefferson. “We recorded no convincing evidence that vaccines can reduce mortality, [hospital] admissions, serious complications and community transmission of influenza. In young children below the age of 2, we could find no evidence that the vaccine was different from a placebo,” Jefferson told Reuters. (9, 10)

In his recent article, Influenza Vaccination of Infants: A Useless Risk Dr. F. Edward Yazbak, a U.S. pediatrician who now devotes his time to the research of autoimmune regressive autism and vaccine injury, offers additional insight into the Cochrane Vaccine Fields study led by Dr. Tom Jefferson. He also analyzed the two studies on which the CDC bases its recommendation of flu vaccination of babies, calling them “limited, weak and irrelevant.” (11) Dr. Yazbak suggests that the CDC and its Advisory Committee on Immunization Practices have a simple choice:

“They can continue recommending the useless influenza vaccination of infants aged 6 to 24 months.” or “They can do the right thing and rescind the 2004 recommendation.”

In a follow up article Dr. Yazbak points to the lack of evidence of safety of influenza vaccines in babies. (12)

Writes Dr. Yazbak, “In a letter to the editor of The Lancet on Sept. 3, 2005, T. Jefferson, S. Smith, V. Demichelli, A. Hamden and A. Rivetti expressed their concerns and frustration at the fact that, though they tried, they were unable to get reliable information regarding the safety of influenza vaccines on the market.

This team has written and published several comprehensive publications on vaccination practices. My most recent article on influenza vaccination of infants 6 to 23 months was mostly based on their impressive review of the efficacy and effectiveness of influenza vaccines in children, a review that included every study they could find in any language.

In the letter to The Lancet, Jefferson and associates expressed deep concern that safety studies were not done, the studies were too old and too small, or the vaccine manufacturer simply refused to allow the team to review the data from the vaccine trials.

The frustrated authors ended their letter stating, ‘We believe all unpublished trial safety data should be readily accessible to both the regulatory bodies and the scientific community on request. Our evidence gives rise to a concern that lack of access to unreported data prevents published data being put into context and hinders full and independent review. This cannot be good for public confidence in these vaccines. (12)

The Canadian Paediatric Society’s Position Paper is in concert with U.S. flu vaccine policies for children and recommends vaccination of all Canadian children older than 6 months including those with immune dysfunction and other chronic diseases. Infants and young children are injected with two doses of the vaccine 30 days apart. “While recognizing that research is needed to determine the efficacy of universal influenza immunization of healthy children between six months and two years of age in the prevention of illness and hospitalization due to influenza (7), the Canadian Paediatric Society agrees with the decision of the National Advisory Committee on Immunization that the risk of hospitalization due to influenza among children in this age group justifies routine influenza immunization……The dosage for children from six to 35 months of age is 0.25 mL. The dose for children, 36 months of age and older, is 0.5 mL.” (13)

In Canada, Vaxigrip and Fluviral are the two vaccines most widely used and are produced by pharmaceutical companies Sanofi Pasteur and ID Biomedical respectively. Product information for Vaxigrip is available on the Sanofi Pasteur website. (14) Fluviral product details are not available on the ID Biomedical website.

According to a July 13, 2005 press release, ID Biomedical has been granted a ten-year mandate from the Government of Canada in 2001 to assure a state of readiness in the case of an influenza pandemic and provide influenza vaccine for all Canadians in such an event. It also currently supplies approximately 75% of the Canadian government’s influenza vaccine purchases. (15)

Resistance to Anti-Viral Flu Agents Increasing Worldwide

A second paper published in the Lancet (Sept.21/05) (7) has found that since the mid-nineties, worldwide resistance to drugs used to treat influenza has increased by 12%. Researchers from the U.S. Centers for Disease Control found that influenza viruses, particularly those from the dreaded bird flu strain, have developed resistance to commonly used antiviral drugs such as amantadine. In China and other parts of Asia, resistance is said to be as high as 74%.

Dr Rick Bright of the CDC is quoted in the Lancet press release: “We were alarmed to find such a dramatic increase in drug resistance in circulating human influenza viruses in recent years. Our report has broad implications for agencies and governments planning to stockpile these drugs for epidemic and pandemic strains of influenza. With the increasing rates of resistance shown here, amantadine and rimantadine will probably no longer be effective for treatment or prophylaxis in the event of a pandemic outbreak of influenza.” All human cases of the bird flu (H5N1) strain – which is still extremely rare in humans – have been resistant, the researchers said.

For the developing world, these findings may be ominous because wealthier nations have been stockpiling newer and vastly more expensive antiviral drugs like Tamiflu which are still under patent protection and not available in the cheaper generic form.

Researchers speculate that one reason why resistance rates to the older, cheaper antiviral drugs in Asia jumped so much and skyrocketed after 2002, is that doctors there started prescribing the drugs far more widely after the advent of bird flu in 1997 and SARS, in 2002. (1)

Although actual human cases of these two diseases are rare, the death rate is high which is why patients are given antiviral drugs when they develop a respiratory illness, even though most cases will be nothing more than a common cold. Antiviral drugs work only if they are started within 48 hours of the onset of symptoms and, in that period, it is generally impossible to tell if patients have a deadly strain of flu or merely a mild virus.

The new research demonstrates how quickly and unexpectedly flu viruses can become impervious to medicines once they are put into common use. Antiviral medicines do not cure influenza. They function by cutting down on transmission of the disease and reduce somewhat the symptoms and complications in those already infected.

Dr Jefferson concludes: “We need a more comprehensive and perhaps more effective strategy in controlling acute respiratory infections, relying on several preventive interventions that take into account the multi-agent nature of infectious respiratory disease and its context (such as personal hygiene, provision of electricity and adequate food, water and sanitation).” (7)

References

  1. 2 Studies Question the Effectiveness of Flu Vaccines by Elisabeth Rosenthal, The New York Times, September 21, 2005
  2. Studies question flu vaccines’ effectiveness by Rob Stein, The Washington Post, reprinted in the Seattle Times, Sept. 22, 2005
  3. Statement on Influenza Vaccination for the 2005-2006 Season, Canada Communicable Disease Report Volume 31 • ACS-6, 15 June 2005.
    French version: Déclaration sur la vaccination antigrippale pour la saison 2005-2006
  4. Mass influenza vaccination in Ontario. Vittorio Demicheli: Rebuttal — responds to Dr. Schabas: Canadian Medical Association Journal • January 9, 2001; 164 (1) French Version available on site
    http://www.cmaj.ca/cgi/content/full/164/1/41
  5. Mass Influenza Vaccination in Ontario: Is It Worthwhile? Vittorio Demicheli: CMAJ • January 9, 2001; 164(1)
    http://www.cmaj.ca/cgi/content/full/164/1/38 French Version available on site
  6. Can a Universal Influenza Immunization Program Reduce Emergency Department Volume? Canadian Journal of Emergency Medicine, Dianne Groll, MSc;* Bonnie Henry, MD, MPH† Vol. 4 No. 4, July, 2002
  7. Resistance to Anti-Flu Agents Increasing Worldwide, and Flu Vaccines Have Modest Effectiveness in Elderly People. The Lancet, Press Release September 20, 2005:
  8. Two studies find flu treatments fall short CTV.ca News Staff, Sept. 22/05
  9. No Evidence Flu Shots Work for Under-2s – Study, By Patricia Reaney, Reuters, London
  10. Safety of influenza vaccines in children: The Lancet, 2005; 366:803-804 DOI:10.1016/S0140-6736(05)67204-2
  11. F. Edward Yazbak, MD, Influenza Vaccination of Infants: A Useless Risk
  12. Nothing New about Lack of Effectiveness of Influenza Vaccination in Babies by F. Edward Yazbak, MD
  13. Recommendations for the use of influenza vaccine for children. Infectious Diseases and Immunization Committee, Canadian Paediatric Society (CPS) Paediatrics & Child Health 2004;9(7):283-284 Reference No. ID04-01
  14. Sanofi Pasteur vaccine product monographs
  15. ID Biomedical Provides Update on Vaccine Development Programs