CLAIM: A document shows that Pfizer currently recommends against receiving its COVID-19 vaccine during pregnancy and while breastfeeding.
THE FACTS: The document was published by U.K. health officials in late 2020 upon first authorization of the shot, and the same document has since been revised in line with current recommendations that say the vaccine is safe and recommended for both groups. Social media users misrepresented the outdated regulatory document.
“I’m sure it’ll be all over the mainstream news that Pfizer has now declared their COVID vaccines unsafe for pregnancy and breastfeeding after the government coerced and mandated thousands of pregnant women into having one,” one widely shared tweet stated. The post included a screenshot of a document that said, “pregnancy should be excluded before vaccination,” and “COVID-19 mRNA Vaccine BNT162b2 should not be used during breast-feeding.”
The photo did not include the document title, date, where it came from or other identifying details. A review shows the information came from a 2020 version of a document called “Regulation 174 Information For UK Healthcare Professionals” that was publicly available when COVID-19 vaccines were first rolled out.
Britain authorized Pfizer’s shot for emergency use on Dec. 2, 2020. Regulation 174 allows for the approval of a medicine or vaccine in a public health emergency with sufficient data on safety, quality and effectiveness, according to Chofamba Sithole, a spokesperson for the U.K. Medicines and Healthcare products Regulatory Agency.
The document was published by the agency as early as Dec. 8, 2020, an archived version shows. The guidance was updated on Dec. 31, 2020, to offer the vaccine to females of reproductive age without the need to provide a negative pregnancy test, and to high-risk pregnant women, said Dr. Victoria Male, a lecturer in reproductive immunology at Imperial College London. That can be seen in another archived version of the document from Jan. 3, 2021.
The recommendation was updated again in April 2021 to allow all pregnant women to get the COVID vaccine. The current version of the document says “animal studies do not indicate direct or indirect harmful effects with respect to pregnancy.”
About breastfeeding, it says, “it is unknown whether the COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk.” The updates were made as additional safety data and evidence became available demonstrating the vaccine’s safety for such groups.
“This was our assessment at the time of approval for the vaccine,” Sithole wrote in an email, referencing the 2020 version of the document. “Since then new data which has come to light (both non-clinical and post-authorisation ‘real world’ data) supports the updated advice on vaccinating those who are pregnant and breastfeeding.”
Keanna Ghazvini, a spokesperson for Pfizer, declined to comment on the specific documents being shared on social media but pointed to Centers for Disease Control and Prevention and World Health Organization guidance that says any of the currently authorized COVID-19 vaccines can be administered to pregnant or lactating women. The respective guidelines both state that experts believe COVID-19 vaccines are unlikely to pose a risk to pregnant women or fetuses.
Sithole said U.K. data also supports international findings. “There is also no current evidence that COVID-19 vaccination while breastfeeding causes any harm to breastfed children or affects the ability to breastfeed,” the spokesperson added.
— Associated Press writers Sophia Tulp in Atlanta and Angelo Fichera in Philadelphia contributed this report.