Does the Pfizer COVID-19 vaccination do more harm than good? No, that's not true: The video by the Canadian Covid Care Alliance (CCCA) in the Rumble post saying so recycles many previously debunked claims about the COVID vaccine. The Pfizer shot (BNT162b2) received full approval from the Food and Drug Administration (FDA) on August 23, 2021, for people 16 and older and has emergency use authorization for children 5 to 15. It is recommended for people ages 5 and older.
The benefits of COVID vaccination outweigh the known and potential risks, the Centers for Disease Control and Prevention website says. And the first line in the "RESULTS" section of a September 15, 2021, New England Journal of Medicine (NEJM) study on the first six months of the Pfizer vaccine says, "BNT162b2 continued to be safe and have an acceptable adverse-event profile."
The claim appeared in an article and video published on Rumble (archived here) on December 16, 2021, titled "The Pfizer Inoculations Do More Harm Than Good." It opens:
BREAKING: Pfizer's own 6 month report data on its COVID-19 inoculation shows that greater illness and death in the inoculation arm than the placebo arm. Plus, poor trial design, missing data, underpowered studies, passive surveillance and more. For the PDF of this presentation visit: https://www.canadiancovidcarealliance.org/media-resources/the-pfizer-inoculations-for-covid-19-more-harm-than-good/
This is what the article looked like on Rumble on January 4, 2022:
(Source: Rumble screenshot taken on Tue Dec 04 19:41:30 2021 UTC)
There's nothing in the Rumble article posted by the CCCA that supports the claims it makes. The 39-minute video included in the post features 51 slides (PDF can be found here), mainly recycling previously debunked claims about Pfizer's COVID vaccine. One of its main sources is a NEJM study, "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months," which it says proves its claim that the shot does more harm than good.
FDA response
In a January 5, 2022, email to Lead Stories, the FDA called the CCCA's explanation of the NEJM study "false and misleading":
[They] clearly misinterpret information from the New England Journal of Medicine publication. The study does not show an increased risk of illness or death following vaccination with the Pfizer-BioNTech COVID-19 Vaccine. To the contrary: the authors concluded that the vaccine through '...6 months of follow-up and despite a gradual decline in vaccine efficacy...had a favorable safety profile and was highly efficacious in preventing COVID-19.' Subsequent to this trial, and confirming its findings, real world evidence data from various studies have demonstrated the safety and effectiveness of the Pfizer-BioNTech vaccine in reducing morbidity and mortality from COVID-19.
Pfizer response
In another January 5, 2022, email to Lead Stories, Keanna Ghazvini with Pfizer media relations said the report from the CCCA is not a peer-reviewed source and also called attention to the NEJM study:
Of note, the first sentence of the results section confirms this claim and report is false. Based on ongoing safety reviews performed by Pfizer, BioNTech and health authorities, our vaccine retains a positive benefit-risk profile for the prevention of COVID-19 infections. To date, millions of people have been vaccinated with our vaccine.
The CCCA presentation shows no evidence of having been subjected to professional peer review. That's the customary process through which the methodology and conclusions in scholarly writings are challenged by professional peers, sometimes causing authors to restate their findings. While the "More Harm Than Good" video/slideshow lists its sources, the CCCA does not list its authors and deliberately hides their identities. The alliance also claims to be made up of over 500 independent Canadian doctors, scientists and health care practitioners. This is what the group's website says:
We appreciate that inquiring minds would like to see that there are people with real expertise behind the information on CCCA's website. However-
We regret that the state of affairs, censorship of free speech, and rampant tyranny and coercion is such now in Canada that CCCA must protect the identity of its scientific, MD, academic and other health care professional (HCP) members. This serves to shield them from career-impacting reactions by their universities, professional colleges and healthcare system employers. Sadly, some of our MDs have had their medical licenses to practice suspended or restricted because they are not on board with the mainstream narrative. Likewise, some of our university professors have had their contracts terminated. These are dark times, and while we appreciate that some people want to know identities, frankly it would be hazardous to the careers of many of our members for us to reveal them.
New England Journal of Medicine study
The conclusions from the NEJM study are based on data from more than 46,000 people in the United States, Argentina, Brazil, Germany, South Africa and Turkey. Here are some of its findings:
- The Pfizer vaccine continued to be safe and have an acceptable adverse-event profile.
- Vaccine efficacy against COVID-19 was 91.3% through six months of follow-up.
- There was a gradual decline in vaccine efficacy.
- Vaccine efficacy against severe disease was 96.7%.
In an email to Lead Stories from December 13, 2021, Pfizer said multiple vaccine safeguards are in place:
FDA has placed a strong focus on monitoring the safety of the COVID-19 vaccines. As part of this effort, the manufacturers of the COVID-19 vaccines submitted pharmacovigilance plans to FDA to monitor the safety of their vaccines. The pharmacovigilance plan for each vaccine includes a plan to complete long-term safety follow-up for participants enrolled in ongoing clinical trials. These plans also include other activities aimed at monitoring the safety of the vaccines to ensure that any safety concerns are identified and evaluated in a timely manner.
Additionally, the manufacturers and vaccine administrators are required to report to VAERS (Vaccine Adverse Events Reporting System) any adverse event that involved hospitalization, prolongation of existing hospitalization, life-threatening illness, permanent disability, congenital deformity, or death. These reports were required to be submitted irrespective of attribution to vaccination.
With the Vaccine Adverse Events Reporting System, anyone with internet access can add a report to the VAERS list of reports. The public access link to it expressly warns against unwarranted conclusions based on VAERS material because the list only provides a tally of unverified notes about any health event people experience after they are vaccinated, and multiple people can file reports on the same event.
Other claims
The CCCA video also recycles these claims about the Pfizer shot that have already been addressed in Lead Stories fact checks:
Lead Stories has also debunked dozens of other claims challenging the safety and effectiveness of the Pfizer COVID vaccine and those made by other manufacturers.
