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SciCheck’s COVID-19/Vaccination Project

COVID-19 Vaccine Data Was Peer-Reviewed, Contrary to Meme’s Claim


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SciCheck Digest

The COVID-19 vaccines have been the subject of peer-reviewed studies that found they were effective and safe, but a meme has been circulating on social media falsely claiming that no such studies have been conducted.


Full Story

Clinical trials for the three COVID-19 vaccines available in the U.S. included tens of thousands of participants and have each been the subject of peer-reviewed studies.

But a meme circulating on social media has been spreading a false claim saying the opposite.

The meme includes this heading: “Things NOT being offered to take the Covid jab.” Then it lists: “Peer reviewed clinical studies proving its safety and efficacy” and “Liability when something goes wrong.”

It’s easy enough to show the first claim is false. The New England Journal of Medicine — a peer-reviewed publication — has published studies finding that the vaccines from Moderna, Pfizer/BioNTech and Johnson & Johnson are effective and safe. The NEJM is the oldest continuously published general medical journal in the world and is among the most frequently cited journals.

It’s also worth noting that more than 290 million vaccines have been administered across the country so far with only rare documented cases of serious adverse reactions, including anaphylaxis occurring in approximately 2 to 5 patients per million.

There also have been 32 cases of a rare and dangerous blood clotting condition (primarily in women under 50) among the 10 million people who received the J&J vaccine. The CDC has said that its review of those cases “has not established a causal link,” but “recent reports indicate a plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and a rare and serious adverse event — blood clots with low platelets — which has caused deaths.” There have been three deaths linked to the condition as of May 7, the CDC said

(See SciCheck’s articles on each of the vaccines: “A Guide to Moderna’s COVID-19 Vaccine,”A Guide to Pfizer/BioNTech’s COVID-19 Vaccine” and “A Guide to Johnson & Johnson’s COVID-19 Vaccine.”)

The Liability Claim

As for the second part of the claim, it’s true that the companies making the vaccines are largely shielded from liability. But that doesn’t mean that there’s no recourse for those who, in rare instances, might be harmed.

The Public Readiness and Emergency Preparedness Act of 2005, or PREP Act, provides liability protection for companies involved in producing drugs or other products that help respond to a pandemic. That’s what covers the COVID-19 vaccines.

A recent Congressional Research Service report explained, “In the PREP Act, Congress made the judgment that, in the context of a public health emergency, immunizing certain persons and entities from liability was necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered.”

The liability protection is broad, as we’ve explained before, although it doesn’t extend to death or a serious physical injury that results from willful misconduct.

And, importantly, there’s a system called the Countermeasures Injury Compensation Program, or CICP, that provides compensation for those harmed by vaccines, including those for COVID-19, and other products.

CICP gives benefits to individuals, or to estates of individuals, “who sustain a covered serious physical injury as the direct result of the administration or use of covered countermeasures,” including COVID-19 vaccines, according to the program’s website.

Health Resources & Services Administration spokesman David Bowman told us before that people have a year to submit a claim, which is reviewed by medical staff to determine if the individual experienced a covered injury. The decision, he said, is based on “compelling, reliable, valid, medical and scientific evidence.”

Since its inception in 2010, Bowman said, CICP has paid out a total of $5.7 million for 39 claims.

Most other vaccines — those not related to the pandemic — are covered by the National Vaccine Injury Compensation Program, or VICP, which has a fund available to those who may have suffered rare vaccine-related injuries.

VICP was created after lawsuits against vaccine manufacturers and health care providers in the 1980s threatened to cause vaccine shortages and reduce vaccination rates, according to the HRSA, which administers the program. It began accepting petitions for compensation in 1988 and, since then, has received more than 24,084. Of those, “19,784 petitions have been adjudicated, with 8,028 of those determined to be compensable, while 11,756 were dismissed. Total compensation paid over the life of the program is approximately $4.5 billion,” according to a recent HRSA report.

From 2006 to 2019, more than 4 billion doses of covered vaccines were administered and 5,755 people were awarded compensation, meaning approximately one person was compensated for every 1 million vaccinations, the report said.

“Being awarded compensation for a petition does not necessarily mean that the vaccine caused the alleged injury,” the report added. “In fact, [a]pproximately 60 percent of all compensation awarded by the VICP comes as result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.”

Editor’s note: SciCheck’s COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over our editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.

Sources

Baden, Lindsey, et al. “Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.” The New England Journal of Medicine. 30 Dec 2020.

Polack, Fernando, et al. “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.” The New England Journal of Medicine. 10 Dec 2020.

Sadoff, Jerald, et al. “Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19.” The New England Journal of Medicine. 21 Apr 2021.

Congressional Research Service. “The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures.” Updated 19 Mar 2021.

Hale Spencer, Saranac, Jessica McDonald and Angelo Fichera. “New ‘Plandemic’ Video Peddles Misinformation, Conspiracies.” FactCheck.org. Updated 21 May 2021.

Health Resources & Services Administration. Countermeasures Injury Compensation Program (CICP). Accessed 27 May 2021.