COVID-19 Vaccine Data Was Peer-Reviewed, Contrary to Meme's Claim - FactCheck.org

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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.

All of the authorized vaccines are effective at preventing symptomatic disease.

According to the results of the phase 3 trials, the Pfizer/BioNTech and Moderna vaccines had an efficacy of 94% or higher, which means your approximate risk of getting sick is cut by 94% or more if you are vaccinated. It’s important to keep in mind that the effectiveness of the vaccines outside the controlled setting of a clinical trial is typically somewhat lower. A study by the Centers for Disease Control and Prevention found these two vaccines were 90% effective in real-world conditions, two weeks after the second dose, and 80% effective two weeks after the first dose. The study monitored 3,950 health care personnel, first responders and other essential workers for 13 weeks.   

Johnson & Johnson’s phase 3 trial began in late September, nearly two months after the Pfizer and Moderna trials and shortly before a new variant of the coronavirus emerged in South Africa. Globally, J&J reported an efficacy of 66.1% in preventing moderate to severe COVID-19 and an efficacy of 85.4% in preventing severe or critical COVID-19. But efficacy was higher in the U.S. population (72% efficacy in preventing moderate to severe disease and 85.9% efficacy in preventing severe or critical disease) than in South Africa (64% and 81.7% efficacy in preventing moderate to severe or severe/critical disease, respectively).

Data from the Moderna trial also demonstrate that the vaccine protects against severe COVID-19. The Pfizer/BioNTech vaccine probably does as well. But because so few participants in that trial developed severe COVID-19, this hasn’t yet been conclusively shown. The J&J trial showed 100% efficacy in preventing COVID-19 that would require medical intervention — meaning hospitalization, ICU admission, mechanical ventilation or a life support machine.

Although the trials show the vaccines protect against symptomatic disease, what is still unknown is whether these vaccines protect against infection with the coronavirus, and if not, whether they can prevent someone from spreading the virus to others. (See our video on the distinction between virus and disease.) However, the CDC has said that “a growing body of evidence” suggests those who are fully vaccinated are “potentially less likely to transmit SARS-CoV-2 to others.”

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No serious safety concerns were found in the clinical trials of the vaccines that have been authorized for use in the United States. 

On April 13, the CDC and Food and Drug Administration recommended “a pause in the use” of the Johnson & Johnson vaccine. The agencies lifted the pause on April 23, shortly after the CDC’s Advisory Committee on Immunization Practices voted 10-4 to resume the vaccine’s use with a warning about a rare, severe type of blood clot and low blood platelets that mostly occurred in women aged 18 to 49 years old. As of May 24, the agencies had identified 32 total cases among more than 10.2 million J&J vaccines administered. There have been three deaths linked to the blood clotting condition, as of May 7, according to the CDC.

Since the rollout of the Pfizer/BioNTech and Moderna vaccines in December 2020, a small number of people in the U.S. have had serious allergic reactions following receipt of the shots. 

Some allergic reactions, including a potentially life-threatening reaction known as anaphylaxis, are to be expected with any vaccine. Fortunately, that kind of severe reaction is typically very rare, occurs within minutes of inoculation and can be treated. 

As of Jan. 18, there have been 2.5 cases of anaphylaxis per million doses of the Moderna vaccine and 4.7 cases per million of the Pfizer/BioNTech vaccine, according to a report by the Centers for Disease Control and Prevention. Those who develop anaphylaxis are usually given epinephrine, the drug found in EpiPens. None of these reactions has led to death. On Feb. 26, Johnson & Johnson said it had received a report of one anaphylactic reaction in South Africa.

To make sure serious allergic reactions can be identified and treated, all people receiving a vaccine should be observed for 15 minutes after getting a shot, and anyone who has experienced anaphylaxis or had any kind of immediate allergic reaction to any vaccine or injection in the past should be monitored for a half hour. People who have had a serious allergic reaction to a previous dose or one of the vaccine ingredients should not be immunized. Also, those who shouldn’t receive one type of COVID-19 vaccine should be monitored for 30 minutes after receiving a different type of vaccine.

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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.

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