Fact Checking The Fact Checkers
In late December we were pleased to launch our video “More Harm than Good” which was inspired by our Critique of the Thomas et al. 2021 NEJM Publication which has recently been submitted for publication. Since then, we’ve received some great feedback, some requests for clarification and some critical reviews including a Fact Check by AFP. In the spirit of open scientific discourse and debate we present our responses to the AFP check in this below.
About AFP: AFP is stated to be a for profit organization that seeks to give French and foreign users precise, impartial and trustworthy information in a regular, uninterrupted manner. It must, in no circumstances, fall under the control of an ideological, political or economic group. The AFP fact checked our video on January 4, 2021 and their full analysis can be found HERE.
Despite their stated objectives, AFP’s board of directors has five members with direct political ties, two members from government owned radio and television, and three government representatives: the minister of finance, the minister of foreign affairs and the Director General of Media and Cultural Industries who is appointed by the minister of culture (AFP, Board of Directors). It is difficult to imagine how the AFP can remain politically neutral while much of its funding comes from the French government (Allsop, Columbia Journalism Review) and a number of its ministers sit on the board of directors. Their one-sided, pro-narrative response lacks scientific rigour, and certainly does not reflect AFP’s stated commitment to the dissemination of trustworthy and impartial information.
AFP 1: Animal testing was skipped. “The video claims that animal testing was “skipped” during the vaccine’s development, leading to compromised safety. That is false. Pfizer-BioNTech tested the mRNA shot on rhesus macaques and that data was reviewed by Health Canada prior to authorization of the vaccine. Although the COVID-19 shots are the first to use mRNA technology, research on it started in the early 1990s, and included promising tests on animals.’
Preclinical testing is conducted to prove the short and long-term safety and efficacy of the vaccine in animal models before assessment in humans. Although some animal studies of BNT162b2 were conducted, to expedite development, these studies were done in tandem with the clinical trials and in some instances toxicology data from the lipid nanoparticle carrier components of the vaccine were accepted in lieu of BNT162b2 data (Pfizer/BioNTech FDA EUA Presentation.) The short and long-term safety results of the inoculation in humans was unknown at the time of clinical trial recruitment. In fact, at the time of FDA EUA approval in December 2020, only unpublished short term outcomes from two toxicology studies and one immunogenicity trial were available. Studies assessing reprotoxicity and teratogenicity were ongoing and no genotoxicity or oncotoxicity studies were underway. What this means is that the animal testing which is usually completed prior to assessment in humans to ensure both the short and long-term safety of the inoculation was skipped and some safety questions such as whether the inoculations could alter the human genome or cause cancer remained unanswered at the time of approval.
The fact that mRNA technology was previously studied in animals prior to COVID-19 does not support the safety of this technology, which is used to produce the pathogenic Spike (Wang et al., Suzuki et al., Lei et al., Biancatelli et al., Solopov et al.) protein in humans. In fact, the small scale phase I study of the Moderna COVID-19 vaccine published in NEJM by Jackson et al. also highlighted previous animal studies with coronavirus vaccines that raised concerns regarding the “potential for development of vaccine-associated enhanced respiratory disease with vaccine antigens that induced antibodies with poor neutralizing activity and Th2-biased responses.”
Moreover, the previous studies using the lipid nanoparticle delivery system were mainly for targeted chemotherapy to deliver toxins and drugs into cancer cells or liposomes coated with proteins from viruses, bacteria or fungi as vaccine formulations for update by immune cells. The delivery of genetic information with a lipid nanoparticle to generate the foreign proteins as antigens to elicit an immunoresponse against a vaccinated person’s own body cells has never been regulatory agency-approved for human use before. Since the mechanism of action to generate adaptive immunity requires requires inflammatory attack of the cells expressing the foreign protein on their surface, there are strong hypothetical reasons why repeated booster injections of the RNA vaccines may result in breakage of tolerance leading to autoimmune disease from production of antibodies and activation of T lymphocytes against the proteins of
the body’s own cells. It is also feasible that repeated injections that result in high doses of the foreign protein on the surface of the body’s cells may induce tolerance against the virus by favouring the destruction of T- and B-cells that target the viral proteins. This might account for the high rates of breakthrough COVID-19 cases in double vaccinated populations.
AFP 2: Safety of COVID-19 vaccine in pregnant and breastfeeding women. “The video claims that because pregnant and breastfeeding women were excluded from Pfizer-BioNTech’s clinical trial, there “has never been any data to make safety claims about those people and inoculations.” This is false. Studies have followed pregnancy outcomes, particularly in health care workers who were among the first to receive the COVID-19 shots.” … pregnant individuals are considered a high-risk population for COVID-19 complications and appeals to the Society of Obstetricians and Gynaecologists of Canada recommend vaccination against the disease “during pregnancy in any trimester and while breastfeeding.”
The precautionary principle is the standard that governs care of pregnant women and their unborn or breastfeeding children (45 CFR 46, Subpart B; FDA DPMH Guidance for Industry.) This means that all agents that have not been proven safe through rigorous testing of both short and long-term clinical and sub-clinical effects on both mother and child should be avoided. The only way to prove safety is through prolonged rigorous testing in a phase III clinical trial that lasts through to the second year of development of the vaccine-exposed neonate. Although drugs have been approved for use in pregnant women based on observational studies following full approval in the general population (FDA DPMT Guidance to Industry), there is no precedent for approval of a vaccine approved under emergency use authorization in the general population and lacking long-term safety data. As pregnant women were not included in the phase III trials, no claims regarding the safety of the inoculation in this population can be made. An absence of “safety signals” from observational studies or small inadequately powered studies looking at transfer of vaccine mRNA in breastmilk are wholly inadequate to support claims of safety. They may provide some insight into whether the vaccines are present in breast milk of vaccinated pregnant women, but do not establish whether the pathogenic spike protein product is in the milk. All of this is a moot point, since it is now being proposed to directly inoculate babies with the COVID-19 vaccines.
Although the AFP refers to pregnant women as a high-risk group, the real world retrospective cohort studies used to support this designation were conducted in either pregnant women who had symptomatic COVID-19 or pregnant women who were hospitalized due to COVID-19 (Zambrano et al., Martinez-Portilla et al., Knight et al., Pineles et al.). As association does not infer causation, severe outcomes cannot be definitely attributed to a women’s pregnant status and statements regarding risk should be appropriately qualified. Additionally, while increased risk of adverse outcomes for pregnant women was observed in large registry studies with substantial proportions of missing data after adjusting for selected confounding factors (Zambrano et al., Martinez-Portilla et al.), results from analyses of hospital network databases (Knight et al., Pineles et al.) did not confirm the increased risk observed in the registry studies. Moreover, outcomes from these trials should be limited to the actual populations studied and should not be extrapolated to the 72% to 98% who have asymptomatic COVID-19 (Woods et al., Sutton et al. and Maru et al.). What AFP should have said was that pregnant women
with symptomatic COVID-19 may be at an increased risk of severe disease. And even if this were true, this would not warrant use of these agents for which the short and long-term safety has not been proven.
The evidence that the AFP provided for the safety of the COVID-19 vaccines to pregnant women was limited to a single study. In the safety assessment “COVID-19 Vaccination During Pregnancy in Ontario – Report #1: December 14,2020 to May 31, 2021 – of 30,670 women that were vaccinated 99.3% had only one dose and 0.7% had two doses, and 84.1% had not given birth yet. Moreover, about 38% of all of the vaccinations occurred in the last month (May) in the study. The first trimester vaccinations would be at greatest risk of developmental issues, but almost no data would be available about the kind of parameters that were assessed in this study, which focused on post-birth metrics, and very few at that. Since pregnancy takes 9 months, the data in Table 2 of this report cannot be compared at all the range of background rates in Ontario, which is based on full 9 month terms. Therefore, there was no way to make a valid comparison at the time the Ontario Vaccine and Pregnancy study was reported. Moreover, this kind of limited data cannot be used to address the safety of the vaccines to embryos and babies prior to birth.
AFP3: Death of Danish footballer Eriksen: The video includes several clips of news broadcasts, including one from the Euro 2020 football tournament in which Danish footballer Eriksen collapsed on the pitch during a match against Finland on June 12, 2021. At the time, AFP investigated claims that Eriksen’s collapse was related to a Covid-19 vaccine, but the Danish Football Association and the director of his club Inter Milan said he had not been vaccinated.
We included the video montage of athletes collapsing on the field to highlight the fact that there have been an unusual number of athletes collapsing on the pitch. Our point was that such episodes were rare and no longer based on the number of such stories in the news. Although Eriksen was not vaccinated, many healthy young athletes at little to no risk of severe COVID-19 have been required to be vaccinated to continue to play or compete. Many had to undergo the procedure despite clear warnings on the COVID-19 Vaccine Product Monograph indicating an increased risk of myocarditis and pericarditis, a risk that is particularly acute among young men (PHO Myocarditis and Pericarditis Dec 4 to Sept 4 2021).
AFP 4: Pfizer Pharmacovigilance Safety Report. “The video points to a document released by the US Food and Drug Administration to claim that it revealed more than 1,200 deaths related to Pfizer-BioNTech’s Covid-19 vaccine in a 90-day period. This document has been misleadingly shared across social media, but does not contain evidence to indicate the vaccine was linked to deaths. The figure of 1,223 fatalities among 158,893 adverse effects reflect “spontaneous” reports from sources that include health officials in several countries, without any verification of the cause, Pfizer spokeswoman Dervila Keane told AFP for a previous fact- check…. A multinational, placebo-controlled, observer-blinded trial reported in the New England Journal of Medicine on December 31, 2020 showed no fatalities among vaccine or placebo recipients and stated: “The safety profile of (the shot) was characterized by short-term, mild-to- moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.”
The video does not claim that reported deaths were due to vaccination. It simply states that Pfizer’s own worldwide pharmacovigilance safety report recorded 1,223 vaccine-suspected deaths in the first 90 days of worldwide vaccine roll-out. It is well recognized that the passive surveillance systems under-report safety signals (Lazarus AHRQ 2010). In this same report Pfizer indicated that they were behind on processing the overwhelming number of COVID-19 vaccine-suspected adverse events that they had received to date and that the report does not reflect the full number of reported events (Pfizer PAAE Report to FDA 2021). So, although we cannot ascribe causation to the vaccine, it is common medical practice to consider such serious adverse events as signals of vaccine safety and that similar reports have been used to shut down vaccine campaigns in the past (Sencer and Miller et al. 2006).
It is also curious that the AFP cites preliminary results from the phase III trial (Polack et al. 2021) that we are critiquing to refute more mature results of the same trial (Thomas et al. 2021).. The most up to date findings of the cited trial show one additional death overall (15 vs 14) of which there were four additional cardiovascular deaths (9 vs 4) where seen in the vaccine compared placebo in the blinded phase, and six additional deaths in vaccine recipients overall compared to the unvaccinated (20 vs 14) with crossover (Thomas et al. 2021).
www.canadiancovidcarealliance.org
