Posts are circulating online claiming a Pfizer document reveals that COVID-19 vaccines are not safe for pregnant women and those breastfeeding. The guidelines, however, are from Britain’s medicines regulator in 2020, not Pfizer; they do not indicate the shots are unsafe during pregnancy or while lactating but highlight a lack of data at the time of publication.
Social media users are sharing screenshots of a document with parts of its text underlined and circled in red, including “COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy” and: “It is unknown whether the COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk."
One user sharing the screenshots wrote: “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.”
The screenshot referenced, however, in fact, shows information from Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) in 2020, which has since been updated. Health authorities in Britain and the United States recommend COVID-19 vaccination for pregnant and breastfeeding women.
The MHRA guidance, known as “Regulation 174”, contains information for healthcare professionals on Pfizer-BioNTech's BNT162b2 COVID-19 vaccine here.
The version of the text now circulating on social media can be seen here, dated Dec. 8, 2020.
An MHRA spokesperson told Reuters via email that “this was our assessment at the time of approval for the vaccine”.
The spokesperson added: “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.
“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.”
The limited evidence available at the time on COVID-19 vaccine safety during pregnancy does not constitute evidence that COVID-19 vaccination has had a negative effect on pregnancy.
The latest version of the information for healthcare professionals, updated on Apr. 27, 2022, does not mention that "COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy” (here).
Evidence the MHRA has reviewed shows “no specific concerns for safety in pregnancy”, according to the UK Health Security Agency (UKHSA) (here).
Elsewhere, the UKHSA details how the Joint Committee on Vaccination and Immunisation (JCVI) has advised that pregnant women are more at risk of severe COVID-19 disease and not to delay vaccination until after they have given birth, but “have their COVID-19 vaccines as soon as possible” (here).
The UKHSA also highlights how more than 100,000 pregnant women in the United States have been vaccinated, predominantly with Pfizer and Moderna vaccines, with no safety concerns identified (here).
The U.S. Centers for Disease Control and Prevention (CDC) also recommends COVID vaccination for pregnant and breastfeeding women, those trying to get pregnant and women who might become pregnant in the future (here).
According to the CDC and Britain’s Royal College of Obstetricians and Gynaecologists (RCOG), COVID-19 vaccines cannot cause infection in anyone, including mothers and their babies (here and here).
A Pfizer spokesperson flagged to Reuters that, based on current knowledge, experts believe that COVID-19 vaccines are unlikely to pose a risk to the pregnant person or fetus.
The spokesperson also highlighted the limited data on the safety of COVID-19 vaccines in lactating people and the effects of COVID-19 vaccines on breastfed infants, milk production and excretion, which is also highlighted by the CDC here.
The CDC advises, however, that while more data are needed to confirm what level of protection is provided to babies, reports have shown that breastfeeding people who have received mRNA COVID-19 vaccines have antibodies in their breastmilk (here).
Reuters has previously addressed false claims around COVID-19 vaccination, pregnancy and breastfeeding here and here.
There is also no evidence to support claims that COVID-19 vaccines are causing miscarriages, as Reuters previously reported here.
VERDICT
Missing context. The screenshot is not of a Pfizer document but 2020 guidance from Britain’s Medicines and Healthcare Products Regulatory Agency, which has since been updated. It is not evidence that COVID-19 vaccines are unsafe during pregnancy or while breastfeeding.
Reuters.
