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Video misrepresents Pfizer’s COVID-19 vaccine clinical trial protocol

April 27, 2021 GMT

CLAIM: Pfizer warns people not to have unprotected sex after the second COVID-19 vaccine dose for up to 28 days because of the risk of “birth defects due to genetic manipulation.”

AP’S ASSESSMENT: False. Pfizer didn’t say that its COVID-19 vaccine may cause birth defects. A Pfizer document issued before the vaccine received emergency authorization from the U.S. Food and Drug Administration states that people who participated in clinical trials should take measures to avoid pregnancy. Pregnant women are excluded from clinical trials for safety purposes.

THE FACTS: A TikTok video that also circulated on other social media platforms falsely claimed that the Pfizer vaccine can cause birth defects. The false claim began circulating in December, but resurfaced after a large study published last week provided further evidence that the COVID-19 vaccines made by Pfizer and Moderna are safe for pregnant women.

“Page 132 of Pfizer vaccine..basically says no unprotected sex up to 28 days after 2nd dose due to reproductive safety risk..this is for males and females..births defects due to genetic manipulation,” text in the video falsely states.

The AP has debunked posts claiming the COVID-19 vaccine can alter DNA.

The U.S. Food and Drug Administration granted emergency authorization for Pfizer’s COVID-19 vaccine in December. Before that, the vaccine was tested in clinical trials that excluded pregnant women. Page 132 of a Pfizer protocol document instructs clinical trial participants to take measures to avoid becoming pregnant or getting someone pregnant “for a minimum of 28 days after the last dose of study intervention.” Pfizer began testing the COVID-19 vaccine on pregnant women in February.

Medications and vaccines are typically tested in young, healthy people who are not pregnant or at risk of getting pregnant, said Dr. Andrea L. Cox, a professor of medicine at the Johns Hopkins University School of Medicine. Once proven to be safe among healthy adults, then drugs and vaccines can be tested on pregnant people, children and more vulnerable populations.

Whenever clinical trials are run and usually, again, no matter what you’re testing, there is a higher safety bar set for pregnant people because it’s key that we know something before we put a developing, potentially a developing fetus at risk as well as the pregnant woman,Cox said.

Dr. Arnold Monto, a professor of epidemiology at the University of Michigan School of Public Health, said there was nothing unusual about Pfizer’s instructions to clinical trial participants.

“I think the wording on contraception is pretty typical of an early study when you are being cautious,” Monto said.

Data from researchers at the federal Centers for Disease Control and Prevention that was published last week in the New England Journal of Medicine bolstered evidence the COVID-19 vaccine is safe for pregnant women. Preliminary results are based on reports from over 35,000 U.S. women who received either the Moderna or Pfizer shots while pregnant, the AP reported.

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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.

Here’s more information on Facebook’s fact-checking program: https://www.facebook.com/help/1952307158131536