SciCheck Digest
A vaccine security surveillance examine from the Meals and Drug Administration has been misrepresented on-line. The paper didn’t set up a hyperlink between the Pfizer/BioNTech COVID-19 vaccine and blood clots, as some have claimed — and to this point, different, extra strong analysis has not recognized such associations.
How do we all know vaccines are protected?
Full Story
The Meals and Drug Administration revealed an article within the journal Vaccine on Dec. 1 that described an early warning system for vaccine security and famous that the system recognized some potential security indicators for the COVID-19 vaccine from Pfizer/BioNTech that must be investigated additional.
Amongst them have been pulmonary embolisms, or blood clots within the lung, a situation that calls to thoughts one of the crucial generally superior claims made by anti-vaccination campaigners — the unfounded concept that COVID-19 vaccines are inflicting widespread demise attributable to blood clots.
A few weeks after the article was revealed, the Epoch Instances — a conservative outlet with a historical past of spreading doubtful claims in regards to the COVID-19 pandemic and vaccines — posted a deceptive headline referencing that now-entrenched narrative, saying: “Pfizer’s COVID-19 Vaccine Linked to Blood Clotting: FDA.”
Then different shops went even additional. Conspiracy theorist Stew Peters, for instance, posted a video that cited the Epoch Instances story and claimed that “the FDA has lastly admitted that Pfizer causes blood clots” and that that is “a part of a mass genocide operation.”
One Fb person shared the video with a message that mentioned, “It’s why it’s referred to as the ‘clot shot.’”
However all of those claims misrepresent the paper.
“The FDA has not discovered any new causal relationships between the Pfizer-BioNTech COVID-19 Vaccine and potential antagonistic occasions of particular curiosity recognized in 2021,” FDA spokeswoman Abby Capobianco mentioned in an e-mail to FactCheck.org.
“The FDA continues to seek out that the Pfizer-BioNTech COVID-19 Vaccine meets the FDA’s rigorous requirements for security and effectiveness and the company strongly believes the potential advantages of COVID-19 vaccination outweigh the potential dangers of COVID-19,” she mentioned.
Right here’s what the paper really mentioned: FDA researchers used a system drawing on information from the Facilities for Medicare & Medicaid Providers for greater than 30 million aged individuals — those that are 65 and older — to take a look at 14 illnesses and monitor their incidence amongst recipients of the three out there vaccines within the U.S. after which examine these numbers to a historic baseline for the incidence of these illnesses.
The mission didn’t examine the reason for the potential security indicators, it solely noticed the frequency of sure well being issues.
It discovered that 4 of the 14 illnesses initially “met the edge for a statistical sign” after COVID-19 vaccination with the Pfizer/BioNTech shot. None met the edge following vaccination with the photographs from both Moderna or Johnson & Johnson.
Then, after additional analysis, three of the initially flagged illnesses — immune thrombocytopenia, disseminated intravascular coagulation and acute myocardial infarction — not met the statistical threshold, leaving solely pulmonary embolism as a possible security sign.
“Our new findings of statistical indicators for 4 necessary outcomes for the [Pfizer] vaccine must be interpreted cautiously as a result of the early warning system doesn’t show that vaccines trigger the protection outcomes,” the researchers wrote. “FDA strongly believes the potential advantages of COVID-19 vaccination outweigh the potential dangers of COVID-19 an infection.”
Deeper epidemiological research that account for elements equivalent to age and nursing house residency are underway to additional consider the potential security indicators, in response to the paper.
As we’ve defined earlier than, the mRNA vaccines — which embody the photographs from Pfizer and Moderna — haven’t been related to any sort of clotting drawback.
In March, Dr. John Su, a medical officer for the CDC’s Vaccine Security Workforce, instructed us, “So far, CDC has detected no uncommon or sudden patterns of blood clots, equivalent to deep venous thrombosis (DVT) and pulmonary embolism (PE) following immunization.”
The J&J vaccine, nevertheless, could cause a selected sort of clotting that additionally entails low ranges of blood platelets. The situation could be very uncommon, and the CDC has really useful the 2 mRNA vaccines over J&J’s, which has accounted for less than a small minority of the vaccine doses administered within the U.S.
“There are very massive inhabitants research involving tens of millions of people who present that there isn’t any enhance in threat with the Pfizer and the Moderna vaccines when it comes to thrombosis,” Dr. Adam Cuker, a hematologist with experience in blood clots at Penn Drugs instructed us in March. “So very, very clear proof that these vaccines don’t trigger clots.”
And that continues to be true now. A assessment revealed in November that checked out all of the out there analysis on the query of mRNA vaccines and clots, which included “six strong research together with evaluation of over 27 million doses of mRNA vaccines,” discovered that “the constant result’s that mRNA vaccines should not statistically related to [venous thromboembolism],” or clots that type in veins.
And, really, vaccination towards COVID-19 may assist to stop blood clots, since it may well stop an infection with the virus that may trigger clotting, as we’ve defined earlier than.
An individual is more likely to get a blood clot after being contaminated with COVID-19 than they’re to get a clot after being vaccinated, Allison Burnett, president of the Anticoagulation Discussion board — a corporation that works with well being care suppliers to enhance affected person care — instructed us in September.
“So the message is — get vaccinated to keep away from blood clots,” since getting contaminated can enhance the chance of clots, she mentioned.
The FDA isn’t “taking any regulatory actions” based mostly on the findings of the current paper as a result of the indicators are nonetheless underneath investigation and “require extra strong examine,” the researchers wrote.
“The statistical indicators of 4 critical outcomes should not essentially causal and could also be attributable to elements doubtlessly unrelated to vaccination,” they wrote.
“For instance, the aged Medicare inhabitants that obtained the [Pfizer/BioNTech] vaccine differed from different aged COVID-19 vaccinated populations, together with a preponderance of nursing house residents and populations with the next comorbidity burden,” they wrote.
Once we requested Pfizer for touch upon the claims circulating in regards to the FDA’s paper, a spokesperson instructed us that the corporate takes critically any antagonistic occasions reported after vaccination with its photographs.
“You will need to perceive, nevertheless, that the [adverse events] reported could not have any causal relationship to the vaccine. Somewhat, the occasion could also be attributable to an underlying illness or another issue equivalent to previous medical historical past or concomitant medicine or the [adverse events] could also be coincidental,” the spokesperson mentioned in an emailed assertion.
So, anybody suggesting that this paper has “admitted” or established that the COVID-19 vaccine from Pfizer causes blood clots is unsuitable.
Editor’s notice: SciCheck’s COVID-19/Vaccination Venture is made attainable by a grant from the Robert Wooden Johnson Basis. The inspiration has no management over FactCheck.org’s editorial selections, and the views expressed in our articles don’t essentially mirror the views of the muse. The objective of the mission is to extend publicity to correct details about COVID-19 and vaccines, whereas reducing the influence of misinformation.
Sources
Wong, Hui-Lee, et al. “Surveillance of COVID-19 vaccine security amongst aged individuals aged 65 years and older.” Vaccine. 1 Dec 2022.
Hale Spencer, Saranac, Jessica McDonald and Catalina Jaramillo. “‘Died Instantly’ Pushes Bogus Depopulation Principle.” FactCheck.org. 1 Dec 2022.
Hale Spencer, Saranac. “COVID-19 Vaccine Opponents Misrepresent CDC Webcast on Causes of Blood Clots.” FactCheck.org. 29 Sep 2022.
McDonald, Jessica. “Put up Misconstrues Public Well being Consciousness Campaigns About Blood Clots.” FactCheck.org. 7 Mar 2022.
Jones, Brea. “Airways Are Encouraging, Not Banning, Vaccinated Passengers.” FactCheck.org. 22 Jun 2021.
Capobianco, Abby. Spokeswoman, U.S. Meals and Drug Administration. E-mail to FactCheck.org. 21 Dec 2022.
Robertson, Lori and Eugene Kiely. “Q&A on the Uncommon Clotting Occasions That Precipitated the J&J Pause.” FactCheck.org. Up to date 6 Might 2022.
Facilities for Illness Management and Prevention. Press launch. “CDC Endorses ACIP’s Up to date COVID-19 Vaccine Suggestions.” 16 Dec 2021.
McDonald, Jessica. “Put up Misconstrues Public Well being Consciousness Campaigns About Blood Clots.” FactCheck.org. 7 Mar 2022.
Nicholson, Matthew, et al. “No obvious affiliation between mRNA COVID-19 vaccination and venous thromboembolism.” Blood Critiques. Nov 2022.
Hale Spencer, Saranac. “COVID-19 Vaccine Opponents Misrepresent CDC Webcast on Causes of Blood Clots.” FactCheck.org. 29 Sep 2022.
Spokesperson, Pfizer. E-mail to FactCheck.org. 22 Dec 2022.
