The Pfizer vaccine trial was underpowered to detect rare side effects or efficacy.
It’s true the study was underpowered to detect rare adverse effects although this limitation is typical of studies of its type. Rare adverse effects which were recorded were unrelated to the vaccine. The data in the trial also clearly shows far fewer children who had a vaccine subsequently contracted Covid-19.
An independent review of the vaccines advises that all vaccination should be halted.
The “independent review” claims all reports of side effects after vaccination were caused by vaccination which is unproven.
Children are more likely to produce more harmful spike proteins after they’ve been vaccinated.
The theory that spike proteins produced by Covid-19 vaccines are harmful is unevidenced.
There is a distinct likelihood children will develop myocarditis if they receive a Covid-19 vaccination.
There is some evidence linking Covid-19 vaccines to myocarditis, and the symptoms that have been reported are “very rare” and “typically mild”.
An online article by science pressure group the Health Advisory and Recovery Team (HART) has claimed a video by children’s TV show Newsround made a number of misleading claims about the Pfizer/BioNTech vaccine for children.
Since the video was released, Newsround made one correction in an accompanying article on its website stating “the claim that the vaccine is 100% safe has been removed from an online transcript of this article.”
It also included a statement from UK drug regulator the Medicines and Healthcare products Regulatory Agency (MHRA).
It said: "We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech COVID-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk."
However, a number of other claims HART made are themselves misleading.
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HART said this Pfizer trial was “grossly underpowered” to detect relatively rare serious events as only 1,131 children received the vaccine in the trial and claimed that seven of the children in the trial had severe adverse events associated with the vaccine, one of which was life-threatening.
It also raised questions over the ability of the trial to demonstrate efficacy, claiming that because the risk of symptomatic Covid-19 in children is so low, you would need to vaccinate more than two million people to detect one death.
It is true that the trial, which had over 6,000 participants, was too small to detect very rare adverse events. Dr Jason Oke, senior statistician at the Nuffield Department of Primary Care Health Sciences, University of Oxford, told Full Fact “Trials are rarely, if ever, of sufficient size (or powered) to detect differences in rare adverse events and this trial...is no exception.
“So, I would say that [HART’s] statement is not incorrect but I would suggest that this issue is not unique to this study.”
While seven serious adverse events were detected among the vaccine trial group, none of the events were recorded as being related to the vaccine.
HART’s assessment of Pfizer’s efficacy data (which found 18 cases of Covid-19 in the unvaccinated group, and none in the vaccinated group) appears to only consider vaccination worthwhile if it prevents death.
While the trial was too small to detect a difference in Covid-19 deaths, that was not its purpose. It set out to measure the impact of efficacy of vaccines in reducing the risk of Covid-19, and found the vaccine worked. As Full Fact and others have reported, the vaccine is not only to reduce the risk of dying from Covid-19 (which we have previously reported is close to one in 100,000 in children who catch the disease) but to reduce non-lethal but harmful symptomatic Covid-19, transmission of the disease, and long Covid.
HART also cited an open letter to CEO of the MHRA Dr June Raine as evidence of the vaccines’ harmfulness, claiming it was an “independent preliminary Yellow Card reporting review (which) advises that all COVID-19 vaccination should be halted, pending a full independent safety enquiry.” The “review” argues that 1,253 deaths and 888,196 adverse reactions (ADR) reported via the Yellow Card Scheme were “covid-19 vaccine attributed”.
We’ve said on a number of occasions that reporting of deaths and adverse events following a vaccine does not mean they are connected.
Some adverse events have been investigated and are possibly linked to vaccination. The MHRA has received reports of 389 cases of blood clotting following the AstraZeneca vaccine, of which 68 were fatal. Its advice remains “that the benefits of the vaccine outweigh the risks in the majority of people.” Under 40s however are being offered an alternative to the AstraZeneca vaccine.
According to the latest statistics, there have been 395 instances of anaphylaxis/anaphylactoid reactions in response to the Pfizer/BioNTech vaccine, 16 instances after the Moderna vaccine and 760 after the AstraZeneca vaccine. Anyone with a history of allergic reactions to the Pfizer vaccine or hypersensitivity to the Moderna vaccine have been told to not receive those vaccines.
Reports of Bell’s Palsy (a type of facial paralysis) have been analysed but “so far is similar to the expected natural rate and does not currently suggest an increased risk following the vaccines.”
There have been eight reports of Capillary Leak Syndrome (where fluid leaks from the small blood vessels into the body, which can lead to organ failure and death). While it is an extremely rare condition, whose triggers are not well understood, the MHRA has advised the AstraZeneca vaccine should not be used by anyone with a history of such episodes.
The MHRA also monitored reports of myocarditis and pericarditis (inflammatory heart conditions) following vaccination. It says the reports are “very rare”, “typically mild” and people should attend for vaccination when invited “unless advised otherwise.”
A range of menstrual disorders have been reported after the Pfizer/BioNTech, AstraZeneca and Moderna vaccines but the number of reports are said to be low in relation to the number of women who have had their vaccine and how common such disorders are generally.
Of other adverse events with a fatal outcome following vaccination “review of individual reports and patterns of reporting does not suggest the vaccine played a role in the death.”
HART also claimed that children produce more spike proteins generated by the Covid-19 vaccine.
It claimed recent evidence shows these proteins are harmful. We believe this refers to statements made by viral immunologist Byram Bridle who claimed, just as spike proteins from the Covid-19 virus can enter the bloodstream and cause cellular damage, so can spike proteins generated by the Covid-19 vaccine.
While we don’t know whether children produce more spike proteins following vaccination we recently fact checked Mr Bridle’s comments. Spike proteins generated by the vaccines work differently to those generated by the Covid-19 virus, and so the assumption that spike proteins generated by the vaccine could also harm cells in the bloodstream is unevidenced..
His theory has also been addressed by a number of other scientists and fact checkers.
HART also noted Newsround hadn’t mentioned some of the Pfizer vaccine's side effects, citing a recent FDA report and an upcoming U.S Centers for Disease Control and Prevention (CDC) emergency meeting on associated myocarditis (an inflammation of the heart, which can lead to heart failure).
The CDC reported earlier this month that more than half of the myocarditis cases reported to the U.S Vaccine Adverse Event Reporting System after the second dose of either the Pfizer or Moderna vaccines were in people aged between 12 and 24.
This has led to the FDA adding a warning to the Pfizer and Modera vaccines.
As noted earlier, the MHRA has received reports of myocarditis following vaccination but say instances are very rare, events were typically mild and individuals should still come forward for their vaccine unless advised not to.
This article is part of our work fact checking potentially false pictures, videos and stories on Facebook. You can read more about this—and find out how to report Facebook content—here. For the purposes of that scheme, we’ve rated this claim as partly false because some claims around myocarditis, and the ability of trials to detect rare adverse events are true, while claims around the link between reported adverse events and vaccinations, trial data on vaccine efficacy, and spike proteins are false or unevidenced.
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