Fact check: No, document doesn't show Pfizer warning against vaccine for breastfeeding women

Bayliss Wagner, USA TODAY
·5 min read

The claim: Document shows Pfizer-BioNTech said vaccine should not be given to women who are pregnant or breastfeeding

As the Food & Drug Administration continues to release thousands of pages per month of documents related to its review of the Pfizer-BioNTech COVID-19 vaccine, dozens of posts on Twitter and Facebook claim that one shows Pfizer warning that breastfeeding and pregnant women should not be vaccinated.

"Pfizer has been releasing their court ordered clinical trial data," one Canadian Facebook user wrote in a May 4 post of the screenshot. "This months release states 'Covid mRNA vaccine is NOT recommended for women who are pregnant and it’s also unknown if covid mRNA is excreted in human milk.' I clearly recall our governments pushing the vaxx on expecting mothers. Wake up."

The posts show a screenshot of an unnamed, unsourced document with several sentences highlighted in red, which say that the vaccine is not recommended during pregnancy and that it "should not be used during breastfeeding" because "it is unknown whether COVID-19 mRNA Vaccine BNTI62b2 is excreted in human milk."

However, contrary to the social media claims, the document featured in the post does not come from the documents the FDA has released so far. It also wasn't written by Pfizer.

The quoted document was published by the United Kingdom's drug regulation agency in December 2020, before any significant data was available on the vaccine's efficacy and safety for pregnant and breastfeeding women, the agency told USA TODAY. The updated version of the regulation does not state that pregnant or breastfeeding women are in danger.

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USA TODAY reached out to users who shared the claim for comment.

A health worker administers a dose of the Pfizer-BioNtech COVID-19 vaccine to a pregnant woman at Clalit Health Services in Israel's Mediterranean coastal city of Tel Aviv.
A health worker administers a dose of the Pfizer-BioNtech COVID-19 vaccine to a pregnant woman at Clalit Health Services in Israel's Mediterranean coastal city of Tel Aviv.

Document is 2020 guideline from UK government; has since been updated

The social media posts use an out-of-context photo of an information sheet for health professionals in the United Kingdom, which the country's Medicines & Healthcare Products Regulatory Agency distributed when the vaccine was approved in late 2020.

An archived version of Regulation 174, shows it is the same document as the one in the screenshot. This version was published in December 2020, as UK fact-checking outlet Full Fact reported.

The guideline has since been updated to reflect data from safety reviews and studies conducted in the year and a half since then. The U.K. regulatory agency has found no indications the vaccine is unsafe for people who are pregnant or breastfeeding, a spokesperson for the agency told USA TODAY.

"Over 104,000 pregnant people have received at least one dose of COVID-19 vaccine in England and Scotland, and no concerns of the safety of the vaccines have been raised," spokesperson Laura Kennedy wrote in an email on May 18. "This conclusion is also supported by extensive international data from the rollout of the vaccines in other countries."

Fact check: No evidence Pfizer, Moderna COVID-19 vaccines cause miscarriage

While the UK guidelines still recommend that pregnant individuals consult their doctors with questions about the vaccine, vaccination has been found safe for mothers-to-be and nursing newborns, as USA TODAY has reported.

Both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine recommend COVID-19 vaccination for pregnant individuals.

“ACOG is recommending vaccination of pregnant individuals because we have evidence of the safe and effective use of the vaccine during pregnancy from many tens of thousands of reporting individuals (and) because we know that COVID-19 infection puts pregnant people at increased risk of severe complications,” Dr. J. Martin Tucker, then-president of the college, said in a July 2021 press release.

Fact check: Nursing newborns are not having reactions to COVID-19 vaccine

Pfizer's study on the vaccine's safety and effectiveness for pregnant women is still ongoing. Phase two of three is estimated to be completed in August 2022.

Our rating: False

Based on our research, we rate FALSE the claim that a document shows Pfizer-BioNTech said the vaccine should not be given to women who are pregnant or breastfeeding. The document featured in the post was not written by Pfizer. It is a guideline that was published by the United Kingdom's drug regulation agency in December 2020, before any significant data was available on the vaccine's efficacy and safety for pregnant and breastfeeding women. Experts say studies and worldwide usage have shown the vaccine is safe for pregnant and breastfeeding women.

Our fact-check sources:

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This article originally appeared on USA TODAY: Fact check: Old document used for false claim about Pfizer vaccines

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