Posts misrepresent outdated UK document on COVID-19 vaccines
CLAIM: A document shows that Pfizer currently recommends against receiving its COVID-19 vaccine during pregnancy and while breastfeeding.
AP’S ASSESSMENT: False. The document was published by U.K. health officials in late 2020 upon first authorization of the shot, when the vaccine rollout was still in its earliest stages. The same document has since been revised, in line with current recommendations that say the vaccine is safe and recommended for both groups.
THE FACTS: Social media users are misrepresenting an outdated U.K. regulatory document about Pfizer’s COVID-19 vaccine to falsely suggest it shows that the shot isn’t recommended for women who are pregnant or breastfeeding. “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 stated, “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 being cited came from a 2020 version of a U.K. regulatory 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 where there is 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document offered information about the vaccine to medical professionals and was published by the agency in late 2020, an archived version of the file from Dec. 8, 2020, shows.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.” With respect to breastfeeding, the document says, “it is unknown whether the COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk.”
The changes are in line with revised guidance for women who are pregnant or breastfeeding, which was updated as additional safety data and evidence became available demonstrating that the vaccination is safe for such groups.
“This was our assessment at the time of approval for the vaccine,” Sithole wrote in an email to The Associated Press, 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.”
Male said the vaccine was initially offered using the same criteria that had been applied in the clinical trial, which did not include pregnant women or those who might be pregnant. The guidance was changed when it was found to exclude all females of reproductive age, a large part of the U.K. healthcare workforce, and because pregnant women were found to be more vulnerable to COVID.
Keanna Ghazvini, a spokesperson for Pfizer, declined to comment on the specific documents being shared on social media, but pointed to current Centers for Disease Control and Prevention and World Health Organization guidance.
The respective guidelines both state that experts believe COVID-19 vaccines are unlikely to pose a risk to pregnant women or fetuses. The CDC says “any of the currently authorized COVID-19 vaccines can be administered to pregnant or lactating people.”
Sithole said U.K. data also supports international findings. He highlighted that more than 104,000 pregnant women in England and Scotland have received at least one dose of COVID-19 vaccine and “no concerns of the safety of the vaccines have been raised.”
“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.
This is part of AP’s effort to address widely shared misinformation, including work with outside companies and organizations to add factual context to misleading content that is circulating online. Learn more about fact-checking at AP.