CLAIM: Pfizer admits in its COVID-19 clinical trial protocol document that vaccinated people can "shed" the vaccine, emitting materials that can spread to unvaccinated people by inhalation or skin contact.
AP’S ASSESSMENT: False. COVID-19 vaccines that are in use, including the Pfizer vaccine, cannot spread between people. Posts making the false claim are misrepresenting standard language in the protocol document intended to protect pregnant women and monitor their potential exposure during clinical trials.
THE FACTS: Pfizer’s COVID-19 vaccine does not shed from person to person, nor has the company admitted any such thing.
"The Pfizer-BioNTech COVID-19 vaccine is a synthetic mRNA vaccine and does not contain any virus particles. Because there is no virus produced in the body, no shedding occurs within the human body," Pfizer spokesperson Jerica Pitts told The Associated Press in an email. "The vaccine cannot be inhaled via shedding and can only enter the human body through an administered dose."
The U.S. Food and Drug Administration approved Pfizer’s vaccine in December after extensive clinical trials. Women who were pregnant or breastfeeding were excluded from joining those early clinical studies, and participants were instructed to take measures to avoid pregnancy.
The false posts use a portion of a November clinical trial protocol document that addresses pregnant women to support the bogus theory that a vaccinated person can spread the vaccine or provoke supposed side effects in another person.
The document says any exposures during pregnancy should be reported, and defines such cases broadly to include instances where a pregnant woman is exposed to the vaccine "by inhalation or skin contact" or if a man who received the vaccine or was exposed to it "then exposes his female partner prior to or around the time of conception."
That language can be relevant to other kinds of vaccines, including certain ones that contain live viruses, said Dr. Justin Brandt, an assistant professor at the department of obstetrics, gynecology and reproductive sciences at Rutgers Robert Wood Johnson Medical School.
"That language probably doesn’t have any relevance to this specific type of vaccine platform," Brandt said of the Pfizer COVID-19 vaccine, which does not contain live virus.
Dr. Shobha Swaminathan, an associate professor of medicine at Rutgers New Jersey Medical School, referred to the document’s language as "generic" meant to cover cases of "any potential exposures, including possible accidental ones."
Swaminathan told The Associated Press that "exposure" through inhalation or skin contact could refer to incidents where a pregnant woman was near a syringe that contained the product and accidentally broke.
But in the case of COVID-19 vaccines, the degree of absorption from spilling the vaccine on your skin is "probably going to be negligible to non-existent," Swaminathan said.
Regarding the document’s guidelines requiring reporting if a vaccinated man potentially exposes a woman "around the time of conception," Swaminathan said the language is meant to gather information on any type of exposure before the risks are known.
"Initially, you might not potentially know whether any of the vaccine is actually getting into the semen, if any of the semen are affected," Swaminathan said. At this stage of research, however, she said: "We know that it really does not affect fertility at all."
False posts have misinterpreted this protocol document as evidence that unvaccinated people -- particularly pregnant women -- should keep away from people vaccinated against COVID-19. The AP has previously debunked that false theory.
"It is very easy for these people, who have no understanding of the rigorous regulations and processes involved in undertaking the conduct of a clinical trial and have never been involved in the conduct of a trial to, in isolation, comment on the standard handling processes of investigational products out of context," said Kathleen M. Mullane, director of infectious diseases clinical trials and professor of medicine at the University of Chicago.
This is part of The Associated Press’ ongoing effort to fact-check misinformation that is shared widely online, including work with Facebook to identify and reduce the circulation of false stories on the platform.
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