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

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.

More than half a billion doses of COVID-19 vaccines have now been administered in the U.S. and only a few, very rare, safety concerns have emerged. The vast majority of people experience only minor, temporary side effects such as pain at the injection site, fatigue, headache, or muscle pain — or no side effects at all. As the Centers for Disease Control and Prevention has said, these vaccines “have undergone and will continue to undergo the most intensive safety monitoring in U.S. history.”

A small number of severe allergic reactions known as anaphylaxis, which are expected with any vaccine, have occurred with the authorized and approved COVID-19 vaccines. Fortunately, these reactions are rare, typically occur within minutes of inoculation and can be treated. Approximately 5 per million people vaccinated have experienced anaphylaxis after a COVID-19 vaccine, according to the CDC.

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.

There is evidence that the Pfizer/BioNTech and Moderna mRNA vaccines may rarely cause inflammation of the heart muscle (myocarditis) or of the surrounding lining (pericarditis), particularly in male adolescents and young adults.

Based on data collected through August 2021, the reporting rates of either condition in the U.S. are highest in males 16 to 17 years old after the second dose (105.9 cases per million doses of the Pfizer/BioNTech vaccine), followed by 12- to 15-year-old males (70.7 cases per million). The rate for 18- to 24-year-old males was 52.4 cases and 56.3 cases per million doses of Pfizer/BioNTech and Moderna vaccines, respectively.

Health officials have emphasized that vaccine-related myocarditis and pericarditis cases are rare and the benefits of vaccination still outweigh the risks. Early evidence suggests these myocarditis cases are less severe than typical ones. The CDC has also noted that most patients who were treated “responded well to medicine and rest and felt better quickly.”

The Johnson & Johnson vaccine has been linked to an increased risk of rare blood clots combined with low levels of blood platelets, especially in women ages 30 to 49. Early symptoms of the condition, which is known as thrombosis with thrombocytopenia syndrome, or TTS, can appear as late as three weeks after vaccination and include severe or persistent headaches or blurred vision, leg swelling, and easy bruising or tiny blood spots under the skin outside of the injection site.

According to the CDC, TTS has occurred in around 4 people per million doses administered. As of early April, the syndrome has been confirmed in 60 cases, including nine deaths, after more than 18.6 million doses of the J&J vaccine. Although TTS remains rare, because of the availability of mRNA vaccines, which are not associated with this serious side effect, the FDA on May 5 limited authorized use of the J&J vaccine to adults who either couldn’t get one of the other authorized or approved COVID-19 vaccines because of medical or access reasons, or only wanted a J&J vaccine for protection against the disease. Several months earlier, on Dec. 16, 2021, the CDC had recommended the Pfizer/BioNTech and Moderna shots over J&J’s.

The J&J vaccine has also been linked to an increased risk of Guillain-Barré Syndrome, a rare disorder in which the immune system attacks nerve cells. Most people who develop GBS fully recover, although some have permanent nerve damage and the condition can be fatal.

Safety surveillance data suggest that compared with the mRNA vaccines, which have not been linked to GBS, the J&J vaccine is associated with 15.5 additional GBS cases per million doses of vaccine in the three weeks following vaccination. Most reported cases following J&J vaccination have occurred in men 50 years old and older.

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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.