The Claim: No peer-reviewed study has demonstrated the safety and efficacy of COVID-19 vaccines
Perhaps the biggest prize of all: Ohio is give $ 1 million to five lottery winners who have received the COVID-19 vaccine.
A post shared on social media, however, highlights what he describes as irony in giveaways.
“The things that aren’t offered to take the hit: peer-reviewed clinical studies proving its safety and effectiveness,” says one May 15 version of the Facebook post after listing the various vaccination incentives that have made headlines in recent weeks.
The post has been shared over 300 times. But it’s wrong.
Peer-reviewed data has shown the COVID-19 vaccine to be safe and effective.
The New England Journal of Medicine published the results of phase 3 clinical trials for the two dose regimens Pfizer and Moderna in December and February, respectively. In April, the journal published Johnson & Johnson single-dose vaccine phase 3 data.
All three “have been evaluated by several experts,” said Julia Morin, spokesperson for NEJM, in an email to USA TODAY. “All COVID-19 research papers are published on an expedited schedule and have the same steps as other papers: peer review and statistics, scientific and manuscript editing.”
The account that shared the May 15 post on Facebook did not respond to a request for comment.
The United States Food and Drug Administration emergency use authorization granted for the Pfizer and Moderna vaccines in December and for the Johnson & Johnson vaccine in February.
So far, data has shown injections to be effective, especially in preventing the most severe cases.
In its clinical trial which studied more than 30,000 participants, the Moderna vaccine has been shown to be 94% effective in preventing COVID-19. Pfizer injection was 95% effective a trial that studied nearly 44,000 participants.
These studies have shown that the two-dose vaccines “are remarkably effective,” said Paul sax , professor of medicine at Harvard Medical School, in the NEJM Frequently Asked Questions regarding the vaccine.
“Sometimes the data is so strong that we don’t even need to do a statistical analysis – that’s what happened with these two clinical trials,” he wrote in response to frequently asked questions for the newspaper. “The results have been so good.”
Johnson & Johnson’s single-dose vaccine was over 66% effective in reducing moderate to severe COVID-19, and it reduced the risk of serious illness by 85%, a study published in April showed it. Over 39,000 participants were included in the study. The effectiveness of this vaccine was in part lower because the trial took place at a time when COVID-19 cases across the United States were much higher than during the Pfizer and Moderna trials. Participants were therefore much more likely to be exposed in their daily lives.
The Johnson & Johnson vaccine was the most effective in reducing hospitalizations. Two weeks after the injection, the vaccine was 93% effective in preventing cases of COVID-19 so severe they required hospitalization, the study showed. Four weeks after administration, it was 100% effective in the study group.
These three trials were the “baseline” studies performed on the three vaccines approved for emergency use in the United States, Rachel graham, told USA TODAY, assistant professor of epidemiology at the Chapel Hill School of Global Public Health at the University of North Carolina.
Clinical trials of the three vaccines approved for use in the United States drew similar conclusions about their safety: the side effects were mild to moderate and disappeared within days. Side effects included pain at the injection site, headache, fatigue and nausea, among others.
Johnson & Johnson vaccine injections briefly stopped in April to determine if it was causing blood clots. The clots occurred mainly in adult women under the age of 50, according to the CDC.
The CDC and the FDA have been investigating cases of blood clots in unusual places, such as the brain and abdomen, and low platelet counts, during an 11-day hiatus from vaccine use. Resuming use of the vaccine, the agency said the benefits of the vaccine outweighed the risks.
Since May 18, the CDC identified 30 people who received the vaccine and later developed clotting problems with more than 9.6 million doses of vaccine.
As of May 17, more than 273 million doses of all COVID-19 vaccines have been administered in the United States, according to the CDC.
A CDC system for the public to report adverse reactions to vaccines has received approximately 4,700 unconfirmed reports of deaths after receiving the COVID-19 vaccine at that time, or about 0.0017%. The CDC warns, however, that a report to the vaccine adverse reaction reporting system “Does not mean that the vaccine caused the adverse eventonly that the adverse event occurred some time after vaccination. “
Checking the facts:CDC data on vaccine side effects cannot determine cause
“A review of available clinical information, including death certificates, autopsy, and medical records has not established a causal relationship with COVID-19 vaccines,” according to the CDC.
Sax pointed out that the seven COVID-19-related deaths in the J&J trial were in the placebo group.
Long-term side effects “are extremely unlikely,” according to the CDC, because historically vaccine surveillance has shown side effects to appear within six weeks.
“Millions of people have received COVID-19 vaccines and no long-term side effects have been detected”, according to the CDC website.
Research on the National Library of Medicine online tool returns over 1,000 COVID-19 vaccine research results. Not all of them are peer reviewed, however, as some of them are pre-prints.
Because the vaccines were produced in real time during the pandemic, other research results were published as a “pre-print” ahead of peer review, Graham said. But experts analyzed the studies after they were published.
“There was still a peer review. There has been a very strict peer review of all of these vaccines, ”said UNC’s Graham. “No corner has been cut in the context of clinical trials.”
Although the vaccines were quickly marketed, Graham said they were the product of years of preclinical research.
“These things didn’t come out of nowhere,” she said.
Our decision: False
The claim that peer reviewed studies have not demonstrated the safety and efficacy of the COVID-19 vaccine is FALSE. Clinical trials that analyzed the safety and efficacy of the three vaccines approved for use in the United States have been peer reviewed.
Our sources of fact-checking:
- New Jersey COVID-19 Information Hub, accessed May 25 What is the New Jersey Shot and a Beer program? Which breweries participate?
- The Washington Post, April 27 West Virginia offers incentive to get vaccinated: money
- The Cincinnati Enquirer, May 24 Over 2.7 million people sign up for Ohio’s first Vax-a-Million drawing
- University of Minnesota Infectious Disease Research and Policy Center, Jan. 4 Peer-reviewed data shows high protection for major COVID vaccines
- New England Journal of Medicine, December 31, 2020, Safety and efficacy of the BNT162b2 Covid-19 mRNA vaccine
- New England Journal of Medicine, February 4, Efficacy and safety of mRNA-1273 vaccine against SARS-CoV-2
- New England Journal of Medicine, April 21 Safety and efficacy of the single dose vaccine Ad26.COV2.S against Covid-19
- New England Journal of Medicine, accessed May 25 Covid-19 Vaccine – Frequently Asked Questions
- New England Journal of Medicine, April 15 BNT162b2 Covid-19 mRNA vaccine in a national context of mass vaccination
- Centers for Disease Control and Prevention, March 19 Efficacy of the Pfizer-BioNTech COVID-19 vaccine in residents of two skilled nursing facilities experiencing COVID-19 outbreaks – Connecticut, December 2020-February 2021
- USA TODAY, April 23 Break on COVID vaccine Johnson & Johnson in US lifted by FDA, use to resume
- Centers for Disease Control and Prevention, accessed May 25 Some Adverse Events Reported After COVID-19 Vaccination
- Centers for Disease Control and Prevention, accessed May 25 Vaccine Adverse Event Reporting System (VAERS)
- Centers for Disease Control and Prevention, accessed May 25 Safety of COVID-19 vaccines
- Rachel Graham, Assistant Professor of Epidemiology at the University of North Carolina at Chapel Hill, May 25, telephone interview with USA TODAY
- NEJM Journal Watch, accessed May 28 Biography of Paul Sax
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