Social media posts claim documents recently released by Pfizer show that the company's Covid-19 vaccine is unsafe for those who are pregnant or breastfeeding. This is false; health regulators and independent medical experts say no serious safety signals have been identified following vaccination during pregnancy, and the image in the posts does not show guidance from the pharmaceutical giant but is in fact outdated advice published by the United Kingdom in 2020.
"Remember, 'The vaccine is safe for pregnant women'- let me introduce the paperwork dumped by Pfizer, 50k pages. Now we know why they wanted to keep this hidden for 50+years," says a May 4, 2022 tweet. It includes an image of vaccine guidance, with red underline to highlight: "COVID-19 mRNA Vaccine BNT126b2 is not recommended during pregnancy."
Screenshot of a tweet taken on May 9, 2022
The US Food and Drug Administration was ordered to comply with a Freedom of Information Act request to release thousands of pages from the documents it used to approve the Pfizer-BioNTech vaccine against Covid-19.
However, a reply to the tweet made clear that the text in the image was not from these FDA documents, but was instead old guidance from the UK government.
AFP searched for keywords from the screenshot and found the original document was published for UK health professionals in December 2020.
A spokesperson for the UK's Medicines and Healthcare products Regulatory Agency (MHRA) confirmed the origin of the document, and that it does not reflect the current vaccine guidance.
Like in most clinical trials, pregnant and lactating individuals were excluded from the initial trials for the Pfizer-BioNTech vaccine against Covid-19. The limited data meant initial UK guidance did not recommend the vaccine for those groups.
The MHRA spokesperson said of the document: "This was our assessment at the time."
However, the guidance has been continually updated and the UK government currently strongly recommends the Covid-19 vaccine for pregnant and breastfeeding women.
The MHRA spokesperson said no safety concerns have been raised about taking the Pfizer-BioNTech Covid-19 vaccine during pregnancy, an assessment based in part on the more than 104,000 pregnant people who have received at least one dose of Covid-19 vaccine in England and Scotland.
"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 said.
She told AFP on May 10, 2022: "Because pregnant individuals were not included in the clinical trials, for the first few weeks of the UK's vaccine rollout, it was not offered to them. However, from 1 January 2021, in recognition of the fact that Covid can cause severe disease in pregnancy, including preterm birth and stillbirth, we extended vaccination to pregnant people at high risk."
Male said that data collected since then offers strong evidence in favor of vaccination.
"Formal studies done on more than 208,000 people vaccinated in pregnancy show that there's no increased risk of any pregnancy problems following vaccination. Some of these studies have also followed up babies until they are six months old, and we see no problems in them either -- indeed, there's some evidence that they are protected against catching Covid themselves," she said.
A study of 97,590 persons in Ontario, Canada, found that Covid-19 vaccination during pregnancy was "not significantly associated with increased risk of adverse peripartum outcomes" including hemorrhage, cesarean delivery or admission to a neonatal intensive care unit.
Kathryn Gray, attending physician of maternal-fetal medicine at Brigham and Women's Hospital in Boston, told AFP she "definitely" continues to recommend the Covid-19 vaccine to her pregnant patients.
She pointed to a May 2022 meta-analysis of 23 studies that concluded: "Covid-19 mRNA vaccination in pregnancy appears to be safe and is associated with a reduction in stillbirth."
Additionally, medical associations continue to assert that there is no broad risk to fertility from taking the Covid-19 vaccine.
A statement from American College of Obstetricians and Gynecologists, the American Society for Reproductive Medicine and the Society for Maternal-Fetal Medicine, said: "No loss of fertility has been reported among trial participants or among the millions who have received the vaccines since their authorization, and no signs of infertility appeared in animal studies."
A study published in January 2022 that followed couples in the US and Canada "found that the chances of conception did not change with either partner's vaccination status."
AFP has debunked other inaccurate claims about the Covid-19 vaccine, here.