Even covid-19 can’t kill the anti-vaccination movement
BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m2184 (Published 04 June 2020) Cite this as: BMJ 2020;369:m2184Read our latest coverage of the coronavirus pandemic
All rapid responses
Dear Editor:
Dr. Cunningham argues that the results in Anderson et al. (2020) "do not preclude the possibility that influenza vaccines have significantly increased mortality in the elderly," pointing to a single cherry-picked, statistically-insignificant result. This line of argument echoes US Secretary of Defense Donald Rumsfeld's principal argument leading up to the 2003 Iraq War: "Absence of evidence [of WMDs] is not evidence of absence." Spoiler alert: There were no meaningful stockpiles of WMDs in Iraq.
The influenza vaccine has proved to be safe and efficacious at reducing the incidence of influenza in dozens of randomized controlled trials, the gold standard of empirical evidence. Nothing in our study, or Dr. Cunningham's anecdotes, changes that core conclusion.
Apropos of the original BMJ article, there are now three approved COVID-19 vaccines in the US, and an equal number in the UK. These vaccines have proved safe and efficacious in large-scale clinical trials. The J&J vaccine, which received Emergency Use Authorization last week, achieved an estimated 80% effectiveness against all-cause mortality in its trial (95% CI, 30% to 100%) [1]. Its true effectiveness against all-cause mortality, after accounting for plausible statistical noise, almost surely exceeded 30%.
This is likely the first time in history in which a treatment has plausibly achieved >30% effectiveness against all-cause mortality when tested in a large-scale clinical trial drawn from the general population. It is the result of deploying a highly effective vaccine against a disease that features a historic combination of communicability and lethality. Everyone who has the opportunity to receive an approved COVID-19 vaccine should absolutely do so. I received my first dose of one last week.
Sincerely,
Michael L. Anderson, PhD
References:
[1] "COVID-19 Vaccine Ad26.COV2.S VAC31518 (JNJ-78436735) Sponsor Briefing Document" https://www.fda.gov/media/146219/download
Competing interests: No competing interests
Dear Editor
I thank Michael Anderson for his October 28 rapid response, but am sorry he has such a negative view of my June 8 reference to his article. ( https://bmj.com/content/369/bmj.m2184/rr-4 ) Indeed, the article is a unique addition to our knowledge of influenza vaccines by taking the long view of vaccine impact on mortality and severe illness in the elderly. (Anderson, Dobkin and Gorry. Ann Intern Med 2020;172:445) It is a complex study by three economists, so in September 20 emails I solicited their opinions about a similar reference in another letter. ( https://www.bmj.com/content/370/bmj.m3563/rr-0 ) I have received no replies to my queries…..This is the first time I have heard that my June 8 letter has been shared on social media. I regret this, especially since I scrupulously avoid contact with any social media, perhaps to the point of paranoia!.....Now let me respond to Dr. Anderson’s comments:
1. I agree that the results of his article “do not preclude modest effectiveness of the influenza vaccine against severe outcomes in elderly persons.” They also do not preclude the possibility that influenza vaccines have significantly increased mortality in the elderly. For example, Supplement Table 14 indicates that during six A/H3N2-predominant seasons the vaccines increased the risk of all-cause mortality in elderly men by 16.6% (VE -16.6%, CI -32.2% to -1.1%)
Is this merely an example of the cherry picking Dr. Anderson refers to? I don’t think so, and I urge readers to study the entire article, including the Supplementary Material. As in so many other articles, the abstract cannot be taken at face value. Look carefully at all the data.
2. Some of the study’s results are of potentially large significance for public health and should not be dismissed merely because they are “statistically insignificant.” The results referred to in my June 8 letter were “insignificant” at P=0.09 and P=0.052. The 16.6% mortality increase mentioned above was actually “significant” at P=0.0245. (Since P values were not given in the article or Supplementary Material, I took the trouble to convert vaccine effectiveness and confidence intervals to odds ratios and confidence intervals, and then calculated P values, guided by Altman and Bland, BMJ 2011;343:d2090)…..Incidentally, more than 800 epidemiologists and statisticians have called for the abandonment of “statistical significance” (Amrhein et al, Nature 2019;567:305), a position I recently ratified.
( https://www.bmj.com/content/370/bmj.m3720/rr )
3. I wonder why Dr. Anderson, an economist, so staunchly defends influenza vaccines. During a medical career that began in 1962 seasonal flu shots for healthy individuals have never made sense to me. This has been reinforced by the research and the opinions of distinguished scientists and clinicians, such as Macfarlane Burnet, Kenneth McIntosh, Lone Simonsen, Tom Jefferson, Peter Doshi, Roger Bodewes, Danuta Skowronski, Margaret McCartney, Peter Collignon, and their colleagues. ( https://www.bmj.com/content/371/bmj.m4037/rr-3 ) It has also been reinforced by the knowledge that the CDC habitually exaggerates mortality figures to promote uptake of the vaccines….Over the years I have seen vaccine failures and serious vaccine adverse effects, and I perceive no decline in the frequency of influenza cases or influenza deaths—massive publicity campaigns and frequent reports of “vaccine effectiveness” notwithstanding.
4. I take a dim view of vaccinating healthy children to protect the elderly. There is no evidence that seasonal vaccines save young lives. Furthermore, they subvert the broad and lasting protection afforded by an infection, unpleasant though it may be. The vaccines have caused high fevers, seizures, Guillain-Barre syndrome, oculorespiratory syndrome, and narcolepsy in children and adolescents.
We need to take a hard look at influenza vaccine policies, and Dr. Anderson’s article is one place to start.
ALLAN S. CUNNINGHAM 29 October 2020
Competing interests: No competing interests
Dear Editor
Dr. Cunningham, in a response that is being shared on social media, cites our study as evidence that the seasonal influence vaccine increases mortality amongst the elderly. This is a gross mischaracterization of our results. The positive association he cites between vaccination and mortality is not statistically significant; that is, it is no larger than one would expect due to random chance.
Furthermore, Dr. Cunningham has “cherry picked” amongst our many statistically insignificant results. For women, for example, the vaccine is associated with a (statistically insignificant) decrease in all-cause and respiratory mortality. In lay terms, Dr. Cunningham is looking at a series of 12 coin flips and claiming the coin is biased towards heads because at one point heads came up twice in a row, while ignoring that at another point tails came up twice in a row. In reality, neither of those results is evidence of bias.
We re-emphasize the original conclusions of our article: Our results do not preclude modest effectiveness of the influenza vaccine against severe outcomes in elderly persons. Therefore, continued vaccination of the elderly, particularly with high-dose or adjuvanted vaccines, seems appropriate. Our findings do raise questions about the overall effectiveness of a vaccination strategy that is limited to standard vaccines and focuses too much on elderly persons. Supplementary strategies, such as vaccinating children and others who are most likely to spread influenza, may be necessary to address the high burden of influenza-related complications among older adults.
In short, our findings call for more influenza vaccination, not less.
Sincerely,
Michael L. Anderson, PhD
Competing interests: No competing interests
Dear Editor
After a succession of powerful responses to Katrina Megget's article [1] I would just like to point out when considering the safety of products how unscientific and prejudicial labels such as "the anti-vaccination movemement" and "misinformation" are [2]. In a correspondence involving Dr Paul Offit last year [3] some of us remained unsatisfied about the evidence for the existence of double blind placebo safety trials for the routine schedule, but even Dr Offit has criticised the dangerous race for a COVID-19 vaccine warning among other things [4]:
"Even if a vaccine generates antibodies, it does not prove that the vaccine is effective at preventing infection; it only makes it more likely that the vaccine would be effective...Even with the initial trials, we are likely to have scant data on whether older people will mount an immune reaction and be protected..."
Politicians and journalists totemise vaccines but perpetually fail to acknowledge the scientific limits of the technology and the fallibility of institutions (just as they denigrate critics), and there is a real public danger. A prerequisite for having safe, effective products is allowing people to talk about them, and there is no reason why vaccines should not be like anything else.
[1] Responses to Megget, 'Even covid-19 can’t kill the anti-vaccination movement', https://www.bmj.com/content/369/bmj.m2184/rapid-responses
[2] Katrina Megget, 'Even covid-19 can’t kill the anti-vaccination movement',
BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m2184 (Published 04 June 2020)
[3] John Stone, 'Re: Response to John Stone (2019 Jul 24)', 29 July 2019, https://www.bmj.com/content/365/bmj.l4291/rr-37
[4] Ezekiel J Emanuel & Paul Offit, 'Could Trump Turn a Vaccine int a Campaign Stunt', https://www.nytimes.com/2020/06/08/opinion/trump-coronavirus-vaccine.html
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor
Dear Editor
In 1543, 'De revolutionibus orbium coelestium', described the heliocentric model of the universe as established by Copernicus (1). The Church objected to the, "false Pythagorean doctrine, altogether contrary to the Holy Scripture," and issued a decree suspending the work so that the knowledge would not, "creep any further to the prejudice of Catholic truth."
In 1633 Galileo Galilei was convicted of grave suspicion of heresy for, "following the position of Copernicus, which is contrary to the true sense and authority of Holy Scripture", and was placed under house arrest for the rest of his life (2).
Had the Church been able to prove its point by engaging in objective, scientific discussion rather than relying on a rigid belief system, it might not have had to employ censorship and authoritarianism to establish its superiority in the eyes of the people.
In parallel today, were the vaccine industry and its proponents willing to engage in an unbiassed, evidence-based, scientific discussion with those who question the safety and efficacy of vaccines, they would surely establish the superiority of their position more successfully? One must therefore ask why such an open discussion has not taken place?
Has belief in the safety and efficacy of vaccines now become such an ingrained doctrine that the only course of action open to industry and its supporters is to attempt to denigrate and silence dissenting voices? If so, what does that say about the perception in the eyes of the public of industry’s confidence in its own science?
Book-burning does not seem to be achieving the desired result.
(1) https://en.wikipedia.org/wiki/De_revolutionibus_orbium_coelestium
(2) https://en.wikipedia.org/wiki/Nicolaus_Copernicus#Theology
Competing interests: No competing interests
Dear Editor
Will Covid-19 finally vanquish the anti-vaccination movement? To answer the question Katrina Megget elicits comments from five experts in public health and vaccine politics. (BMJ 2020;369:m2184, June 4) They reach no firm conclusion, but Barry Bloom calls for a vast advocacy campaign and mass screening of social media with harmful misinformation removed. He does not specify what qualifies as “harmful misinformation.”
It has recently come to light that the countries with the highest Covid-19 death rates also have the highest rates of influenza vaccine uptake among the elderly. (www.bmj.com/content/369/bmj.m1932/rr-15) For 20 European countries there was a strong geographic correlation: r=0.730, P<<0.001. I recently updated this and the correlation persists: r=0.744, P<<0.001. (www.worldometers.info/coronavirus, 6/6/20)
“Correlations can be treacherous.” So said The Lancet more than 40 years ago. (Editorial, “The Anomaly That Wouldn’t Go Away” November 4, 1978, page 978) Would Dr. Bloom consider the foregoing correlation to be treacherous? Would he say it is “harmful misinformation”?
This correlation is consistent with case-control studies and one randomized trial associating flu shots with non-influenza virus infections/NIRVs, including coronaviruses. (Cowling et al, Clin Infect Dis 2012;54:1778. Kelly et al, Pediatr Inf Dis J 2011;30:107. Wolff, Vaccine 2020;38:350) There are plausible immune mechanisms, including virus interference, indicating that this could be a causal association.
Danuta Skowronski and her Canadian colleagues recently found that influenza vaccine had “no effect on coronavirus or other NIRV risk.” Furthermore, they re-analyzed Wolff’s study and identified a methodological problem to account for the unexpected 36% increase in risk of coronavirus infection that he found associated with influenza vaccine. (Skowronski et al, Clin Infect Dis, 5/22/20. https://doi.org(10.1093/cid/ciaa626) However, their Table 1 indicates statistically non-significant trends associating influenza vaccination with NIRVs in general and with coronavirus in particular. Crucially, they provide no specific data for the 65+ age group.
Would Dr. Bloom or anyone else in authority consider pursuing the foregoing influenza vaccine/coronavirus/Covid-19 associations?
It remains to be seen whether we ever have a safe and effective vaccine for Covid-19. A number of eminent authorities have expressed serious doubts, and they are not part of “the anti-vaccination movement.” Meanwhile, randomized trials of BCG vaccination are now underway to see if it could reduce the impact of Covid-19. (Curtis et al, Lancet 2020;395:1545, May 16) They were motivated in part by moderate geographic correlations between BCG use and Covid-19 death rates: countries with a long history of BCG use now have substantially lower Covid-19 death rates than countries with shorter histories or non-use of BCG. (Miller et al, medRxiv. https://doi.org/10.1101/2020.03.24.20042937)
A number of factors are believed to affect the large geographic variation in the frequency of Covid-19 disease. One of these is population density, but it is interesting that the geographic correlation of country population density (Wikipedia, 6/6/20) with Covid-19 death rates (www.worldometers.info.coronavirus, 6/6/20) is weak: r=0.380, P=0.1.
One more sour note about influenza vaccination. An observational study with a regression discontinuity design looked at mortality in the elderly over a 14-year period. (Anderson et al, Ann Intern Med 2020;172:445. doi:10.7326/M19-3075. Epub 2020 Mar 3) Table 2 indicates that influenza vaccine was associated with an 8.9% increase in All Cause Mortality in elderly men (VE –8.9%, CI –19.6% to 1.8%), and a 26.5% increase in Pneumonia and Influenza Mortality (VE –26.5%, CI –56.1% to 3%).
Scott Ratzan is quoted at the end of Katrina Meggett’s article: “The pandemic is showing our vulnerabilities when it comes to vaccines and vaccine hesitancy—and it raises the matter of how we protect for future pandemics. This isn’t just a rights matter. This is a community protection matter. Vaccines are our only hope.” Really? In light of the foregoing, some students of the subject might consider this statement an example of “harmful misinformation.”
ALLAN S. CUNNINGHAM 8 June 2020
Competing interests: No competing interests
Dear Editor
As one who has been vaccinated, who has vaccinated goodness knows how many, I will certainly avoid vaccines produced in a hurry.
You know, or should know, it takes years before you can say a particular vaccine is safe. Even then, it depends on your conscientious collection of adverse reactions.
This Covid-19:
Is it mutating?
Will the mutants be blocked by the vaccine?
Will the vaccine actually make the strain more vicious?
How many days, or weeks, or months, or years must elapse before the manufacturer can say, “Yes, my vaccine is safe.”
I ask these questions because the answers will determine whether I accept the vaccine, if offered..
Competing interests: Might get caught by the virus
Dear Editor 5-18-2020
I read with interest Even Covid -19 can't kill the anti-vaccination movement. President Trump’s “Operation Warp Speed,” the crash program to develop a covid-19 vaccine should give any sentient, thinking medical consumer reason for pause. Voices on the left and right, inside and outside of the medical community, are sounding cautionary notes about ignoring established safety protocols to speed development of a covid shot.
Yet Trump is demanding, and getting, short cuts. MSN reported May 5: “Medical staff at the University of Maryland School of Medicine spent early Monday injecting the first few people with a potential vaccine for the coronavirus as part of an accelerated international effort.” “We’re not skipping any steps, but we are speeding them up quite a bit,” said Dr. Kirsten Lyke, and “she’s never done one quite…this quickly.”
What could possibly go wrong? A brief history of “rushed vaccines” from the recent past offers some troubling insights.
The polio vaccine was rushed to market by firms competing not only to save lives, but to cash in on the opportunity as well. Dr. Paul Offit cited in the Washington Post commented; ”Roughly 40,000 got “abortive” polio, with fever, sore throat, headache, vomiting and muscle pain. Fifty-one were paralyzed, and five died, Offit wrote in his 2005 book, “The Cutter Incident: How America’s First Polio Vaccine Led to the Growing Vaccine Crisis.” It was “one of the worst biological disasters in American history: a man-made polio epidemic.” Further, an estimated 10 million Americans were infected with Simian Virus 40 from the early polio vaccines.
The measles vaccine was rolled out in 1963. It was withdrawn within one year. It caused a more virulent and infectious vaccine strain of “atypical measles” that was deadlier than natural measles.
The Urrabe strain measles mumps rubella (“MMR”) vaccine was introduced in Canada in the early 1980’s and withdrawn immediately because it caused aseptic meningitis. Despite the warning, Britain introduced the same shot and withdrew it in 1993 for the same reason.
The 1976 H1N1 flu shot was hurried to the market under the spectre of an impending epidemic. After killing about 20 people and paralyzing numerous more, it was just as quickly pulled.
The original whole cell pertussis shot caused so many injuries and deaths that it was replaced with a safer, attenuated version.
The 2009 H1N1 shot was touted by Dr. Anthony Fauci as “safe and effective.” Australia stopped giving it to children under 5 because 1/110 developed febrile seizures. Over 1500 cases of narcolepsy in Europe, according to the CDC, were caused by this expedited shot.
Ruth Karron at Hopkins has been trying for over a decade to develop a vaccine against respiratory syncytial virus. Early human trials killed two young participants, which highlights the need for careful and staged research protocols.
The dengue vaccine introduced in the Philippines in 2017 by Sanofi was withdrawn. According to NPR, “The Philippines government has indicted 14 government officials over the deaths of 10 children. The government said the officials acted with "undue haste in launching the campaign."
The human papillomavirus vaccine introduced in Maryland in 2007 was “fast tracked” through the regulatory process. The Royal Society of Medicine published in 2020 “A new analysis of the clinical trials of HPV vaccines to prevent cervical cancer raises doubts about the vaccines’ effectiveness.” The HPV shot caused the death of Baltimore County resident Christina Tarsell. There are an additional 720 adverse events described in Maryland, and over 500 deaths worldwide associated with that shot.
Science has been working on vaccines for severe acute respiratory syndrome, Mid-Eastern respiratory syndrome, and even the common cold for decades. The corona virus class experimental class vaccines when tested in animal models do induce the production of disease relevant anti bodies. In each case, the animals have more severe symptoms to the natural pathogens when re-exposed.
William Haseltine wrote in Forbes: “All of the vaccinated monkeys treated with the Oxford vaccine became infected when challenged…. There was no difference in the amount of viral RNA detected… in the vaccinated monkeys as compared to the unvaccinated animals. Which is to say, all vaccinated animals were infected…. It is crystal clear that the vaccine did not provide sterilizing immunity to the virus challenge, the gold standard for any vaccine.” Oxford Group is moving ahead with this covid candidate vaccine.
Trump’s Operation Warp Speed may be based more on political expediency than actual science. That this process can be so politicized, and has been over a period of decades, is concerning.
Josh Mazer, CFP®
Competing interests: No competing interests
Don't exaggerate the effectiveness of influenza and Covid-19 vaccines
Dear Editor,
I thank economist Michael Anderson for his response to my October 29 letter. (Anderson, BMJ rr, 3 March 2021) As before, I urge that students of influenza vaccine effectiveness look at all the data in his original article, including Supplement Table 14, which indicates that during six A/H3N2-predominant seasons the vaccines significantly increased the risk of all-cause mortality in elderly men by 16.6% (VE -16.6%, CI -32.2% to -1.1%, P=0.0245). (https://www.bmj.com/content/369/bmj.m2184/rr-9) Real scholarship requires studying all the data, not just looking at the abstracts of articles—an all too common practice…..Some other points:
1. Dr. Anderson overstates the case for influenza vaccines. They have never been shown to be lifesavers (Doshi, BMJ 2020;371:m4037, Oct 24) and nothing has essentially changed since Michael Osterholm and his colleagues found evidence lacking for their protecting the elderly and called for better vaccines. (Osterholm et al, Lancet Inf Dis 2012;12:36) Truly, influenza vaccines have a troubled history. (https://www.bmj.com/content/371/bmj.m4037/rr-3)
2. It will take many months before we know the true safety and effectiveness of Covid-19 vaccines, even if the authorities fulfill all of their surveillance obligations. Meanwhile, absolute risk reduction (ARR) will put things in perspective for individuals weighing risks and benefits. Pfizer’s vaccine has been “94% effective” overall, but for severe illness the ARR is only 0.02% and the Number Needed To Vaccinate is 5000. For deaths associated with Covid-19 the ARR is only 0.0039% and the NNTV is 25,641. (https://www.bmj.com/content/372/bmj.n567/rr) Such figures will change with time and the acquisition of more complete data…..A case can now be made for vaccinating high-risk individuals, but we should be thinking long and hard about universal vaccination and the prospect of “annual Covid-19 shots.”
3. What do Donald Rumsfeld and WMDs in Iraq have to do with an honest look at vaccine safety and effectiveness?
ALLAN S. CUNNINGHAM 7 March 2021
Competing interests: No competing interests