Fact Check: No, Pfizer-BioNtech Did Not Report "100% Long-Term Protection" of their Vaccine in12-15 year olds, and No Scientific Evidence is Available that Shows It Was "Well Tolerated"
Pfizer and BioNTech released statements with claims not backed by any peer-review data, the gold standard for scientific evidence. Pfizer and BioNTech do not back their own statement.
Claim: “Pfizer’s Covid-19 Shot Offers 100% Long-Term Protection For Young Teens, Trial Shows”
Claim: “Pfizer said two doses of the vaccine were 100% effective against Covid-19, measured from seven days to four months after the second shot.”
Source: Forbes.com
Forbes’ article makes claims using information they must have other than that presented by Pfizer-BioNtech. No support for the claim “Pfizer’s Covid-19 Shot Offers 100% Long-Term Protection For Young Teens, Trial Shows” can be found in the peer-reviewed scientific literature, and no such results were presented in Pfizer’s Forward-Looking Statement.
Pfizer and BioNtech released a non-peer-reviewed “Forward Looking Statement” in which claims they make are not backed by data. They do not themselves back the claims they made.
Claim: “In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial(sic) of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated.”
Source: https://www.businesswire.com/news/home/20210331005503/en/
Source: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal
Let’s unpack the two claims in the key statement:
“In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated.”
The Forward-Looking-Statement is not a peer-reviewed study. The level of evidence required of knowledge claims is peer-review.
“100% Efficacy”: The Forward-Looking Statement contain no data that indicate any measurement made on the reduction of the rate of of SARS-CoV-2 virus infection, PCR test positivity, COVID-19 diagnosis, hospitalization involving COVID-19, or death from COVID-19. The only data mentioned are “antibody responses”. The vaccine is already known to produce antibody responses; the relevant question is whether the antibody responses are effective against currently circulating variants and bring about improved clinical outcomes. No peer-reviewed study on neutralizing antibodies against current SARS-CoV-2 viral types has been published for this age group, and no health outcome data have been published in any peer-reviewed journal for this age group.
“Well tolerated”. The Forward-Looking Statement claims that the vaccine was “well tolerated”, but presents no data on the rates of mild or serious adverse events. It merely states that the adverse events were similar to those seen in older age groups in prior trials, but the FWS fails to cite or mention peer-reviewed scientific literature that reports increased risks of serious adverse events. (See Rose, 2021, Sci Publ Health Pol & Law (2):59-80).
The older age group spectrum of adverse events mentioned in the Forward Looking Statements was worded as follows: “In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)”. No citation was provided for the studies mentioned and no evidence of long-term health outcomes in those receiving the BNT162b2/Comirnaty vaccine has been published.
Pfizer also reported: “Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.” Therefore, “well-tolerated” is a subjective and speculative claim not backed by data, and not supported by analysis of data from VAERS.
Pfizer-BioNTech do not even stand behind the claims made in their press release. They wrote:
“Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.”
JLW Rating: No peer-reviewed studies exist on the long-term efficacy and safety of the Pfizer-BioNtech vaccine on young teens. The forward-looking statements are speculative and not backed by Pfizer-BioNtech, so I rate this one FALSE.
We need to demand scientific evidence for vaccine-based public health policies. The practice of issuing non-peer-reviewed, speculative opinions by press release, which are then treated by the legacy press as “science” must end.
Dear James, your analysis is spot-on every time. I thank you for debunking this outrageous claim by Pfizer which is misinterpreted by this clown reporter, Robert Hart, from Forbes. I directly emailed Robert Hart (the author of this malicious, misinformation- filled Forbes piece) today and asked him to retract his statements if he values his respectability as a journalist. We will see…. I wish you would do the same analysis for the “false evidence” presented by the FDA and ACOG (American College of Obstetrics and Gynecology) which they use to “support” their recommendations to give all pregnant women the mRNA COVID vaccine. Their so called “evidence” is atrocious. It simply doesn’t exist. They present “antibody studies” only in a handful of pregnant women. They claim that since antibodies are detected in a handful of pregnant women the vaccine must be safe for women and the fetus and therefore we should mass vaccinate pregnant women. How utterly and horribly wrong they are! They can make no such claim to safety in that group! They pretend that there is “no evidence of harm” when the truth is there is actually “no evidence at all”! Please do this analysis on ACOGs recommendations and I will send it around to every self respecting OBGYN I know . I will keep you posted if Robert Hart responds to my email. Keep up your excellent work. I love reading everything you write. Your work is outstanding.
The cognitive dissonance experienced when evidence (or lack thereof) such as this is presented to friends and family members with children is just mind blowing.