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Pandemrix vaccine: why was the public not told of early warning signs?

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3948 (Published 20 September 2018) Cite this as: BMJ 2018;362:k3948
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Adverse events: GSK pandemic influenza vaccines

We don't really know if influenza vaccines are lifesavers

BUT WE DON’T REALLY KNOW IF INFLUENZA VACCINES ARE LIFESAVERS

Peter Aitken writes with passion and sincerity about the importance of influenza vaccines, but I believe he has been misled, along with the majority of the population in the UK and US, by massive and recurrent publicity campaigns. It may seem hard to believe, but repeated pronouncements of “…60% vaccine effectiveness…40% vaccine effectiveness…20% vaccine effectiveness…” are based on biased and quite limited research and do not constitute proof that influenza vaccines have done more good than harm in recent decades.

Macfarlane Burnet, 1960 Nobel Laureate and a primary developer of today’s influenza vaccine, didn’t think it was worth much. (Natural History of Infectious Disease 1972, page 212) Kenneth McIntosh warned that we should not routinely give influenza vaccine to healthy individuals until we did multicenter randomized trials over several seasons to be sure that it was safe and effective. (NEJM 2000;342:225) His advice was ignored and by 2010 the vaccine was being recommended annually to the entire US population. This was largely the result of a “Seven-Step Recipe” sponsored by the CDC to use the media to boost demand for the vaccine. (Doshi, BMJ 2005;331:1419) Peter Collignon and his colleagues said, “We need much larger, independent, and better-reported prospective studies that clearly demonstrate that the benefits of influenza vaccines in children far outweigh harms. If, overall, the increased number of cases of ARI plus vaccine side effects are much larger in vaccine recipients than those on placebo, given the low efficacy of the vaccine, then this is a strong argument against current policies advocating routine vaccination of children.” (Collignon, Clin Inf Dis 2015;60:489) Margaret McCartney questioned the value of mass flu vaccination and called for randomized controlled trials. (BMJ 2014:349:g6182)

Lone Simonsen found that from 1968 to 2001 US flu deaths in the elderly increased in concert with their increasing use of flu vaccine. (Arch Int Med 2005;165:265. Science 2005;307:1026) Recent trends in North America show no decrease in influenza frequency or mortality, and we hear increasingly about increased risk of illness from the vaccines, particularly from H3N2 viruses and among the elderly. A few experts are beginning to wonder if recent bad flu seasons are, in part, the direct result of mass vaccination; herd immunity may now be weaker, and some severe cases may be specifically caused by the vaccine via “antibody-dependent enhancement of infection.”

The CDC exaggerates the risks of influenza infections and downplays the risks of influenza vaccines. For example, when they recommended in August 2016 that the use of FluMist be discontinued for US children they cited “low effectiveness.” (Grohskopf, MMWR Recomm Rep 2016;65(RR-5):1-54) In fact, it actually increased the risk of illness from H1N1 viruses: VE -19% (CI -133% to 33%). (Jackson, NEJM 2017;377:534) This fact was never mentioned, but may be relevant in the February 2016 death of an 8 year-old Utah girl. (Lawrence, “Utah family hopes daughter’s death from influenza after FluMist vaccine leads to reform.” Fox13now.com/2016/09/Utah)

The scattergun US campaign for annual flu shots may be relevant to US cases of acute flaccid myelitis/AFM. There have been 362 cases reported in the US since August 2014, mainly in schoolchildren and occurring mainly in the autumn. (CDC, AFM Investigation 10/5/18) Intramuscular injections are known risk factors for paralytic polio when polioviruses, wild or vaccine-associated, are in circulation. (Mawdsley, Lancet 2014;384:300) The same is likely to be true for non-polio neurotropic enteroviruses such as EV-D68 and EV-A71. US public health authorities have been reluctant to investigate this possibility, but it should not be dismissed, particularly since evidence that flu shots are lifesavers is lacking.

Doctor Aitken’s heart is in the right place, but he gives influenza vaccines credit they don’t deserve.

Allan S. Cunningham

Competing interests: No competing interests

10 October 2018
Allan S. Cunningham
Retired pediatrician
Cooperstown NY 13326, USA