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Will covid-19 vaccines save lives? Current trials aren’t designed to tell us

BMJ 2020; 371 doi: (Published 21 October 2020) Cite this as: BMJ 2020;371:m4037

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Covid-19 vaccine trial protocols released

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Covid-19: another vaccine treadmill of dubious benefit?

Dear Editor

Should we be scandalized to learn that Covid-19 vaccine trials may not prove the vaccines to be lifesavers, for the elderly or anyone else? Should we be further scandalized by the suggestion that influenza vaccines have not saved lives? (Doshi, BMJ 2020;371:m4037, Oct 21) A little history may put this in perspective:

1972: Macfarlane Burnet, Nobel Laureate and developer of one of the first influenza vaccines, states that “A vaccine is available but it reduces ones chance of catching flu by only about half. This hardly measures up to our expectations for a modern vaccine.” (Burnet & White, Natural History of Infectious Disease, 4th edition, page 212)…..
2000: Kenneth McIntosh warns against recommending influenza vaccine in healthy young children until randomized trials of the safety and effectiveness of vaccination are conducted and continued through several epidemics in populations large enough to identify any risks of adverse events. (Editorial, NEJM 2000;342:275) His advice is ignored…..
2005: Lone Simonsen and her colleagues report that from 1968 to 2001 US flu deaths in the elderly progressively increased, right along with their increasing use of influenza vaccines. (Arch Intern Med 2005;165:265)…..
2005: Peter Doshi reports that the CDC has been exaggerating influenza mortality figures to promote uptake of the influenza vaccine. They have developed a “Seven-Step Recipe” for providing information to the news media to boost demand. (BMJ 2005;331:1419)…..
2009-2011: Roger Bodewes refers to the “double-edged sword” of annual vaccination because it subverts broad and lasting immunity against influenza. (Lancet Inf Dis 2009;9:784. J Virol 2011;85:11995)…..
2010: Danuta Skowronski and her Canadian collleagues report that the 2008-2009 flu shot doubled the risk of illness from the 2009 H1N1 pandemic flu; the risk is further increased with the number of flu shots received in previous seasons. (PLoS Med 2010;7(4)e1000256). This study altered vaccine recommendations in Canada but was ignored in the US…..
2012: A randomized, placebo-controlled trial in Hong Kong children found that flu shots increased the risk of illness from non-influenza respiratory viruses/NIRVs nearly fivefold. (Cowling et al, Clin Infect Dis 2012;54:1778)…..
2013: The AS03-adjuvanted pandemic A/H1N1 2009 vaccine is reported to be causally-related to narcolepsy in children and adolescents, OR=14.4. (Miller at al, BMJ 2013;346:f794)…..
2014: Margaret McCartney calls for randomized trials of influenza vaccines. Referring to a Cochrane review and the lack of evidence supporting it as a public health measure she states, “Flu vaccination is offered millions of times every year at huge opportunity cost; given so much uncertainty this policy is impossible to justify.” (BMJ 2014;349:g6182)…..
2015: Citing the increased number of ARIs associated with influenza vaccines and their low efficacy, Peter Collignon and his colleagues argue against routine influenza vaccination of children. (Clin Infect Dis 2015;60:489)…..
2016: A large cohort study finds that flu shots given during the first trimester of pregnancy are associated with a 20% increase in the risk of autism spectrum disorder in the offspring (P=0.01), with an attributable risk of 4 extra ASD cases per 1000 women vaccinated. (Zerbo, JAMA Pediatr, online November 28, 2016. Hooker et al, JAMA Pediatr 2017;171:600)…..
2020: A 14-year study finds that influenza vaccines are associated with an 8.9% increase in the risk of all-cause mortality in elderly men (VE -8.9%, CI -19,6% to 1.8%) During six A/H3N2-predominant seasons their all-cause mortality increase was 16.6%! (VE -16.6%, CI -32.2% to -1.1%). (Anderson et al, Ann Intern Med, online March 3, 2020.

The unfortunate history of influenza vaccines should warn us against repeating the process with Covid-19 vaccines. Peter Doshi may be understating the case when he suggests that influenza vaccines have not saved lives. The foregoing history and other observations suggest that in whole populations over the long run seasonal flu campaigns have actually cost lives…..This idea is hard to grasp in the face of massive publicity and reports of “vaccine effectiveness.” The vaccines provide modest short-term protection against seasonal flu, but the VE studies completely ignore adverse effects (e.g. high fever, seizures, narcolepsy, oculo-respiratory syndrome, Guillai-Barre syndrome). They ignore also the increased risk of NIRVs associated with influenza vaccines. ( )

Perhaps the foregoing considerations were part of what prompted Els Torreele to warn us against the rush to create a Covid-19 vaccine. (BMJ 2020;370;m3209, August 18) Perhaps they are part of what prompts Peter Doshi to repeat the warning…..We don’t need another vaccine treadmill that could do more harm than good.

ALLAN S. CUNNINGHAM 23 October 2020

Competing interests: No competing interests

23 October 2020
Allan S. Cunningham
Retired pediatrician
Cooperstown NY 13326 USA <