No, New Pfizer Docs Don’t Show That Vaccines Are Unsafe During Pregnancy

These so-called "Pfizer Docs" have been a source of several false claims.

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Claim

Pfizer Inc. admitted in documents released by the Food and Drug Administration, as part of a Freedom of Information Act request, that the COVID-19 vaccine was unsafe to get during pregnancy.

Rating

Context

This claim is based on a years-old screenshot from Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) website that was not included in any “Pfizer docs.” This warning about pregnant women taking the vaccine has been revised since it was first published in December 2020. Health authorities in Britain and the United States continue to recommend the COVID-19 vaccination for both pregnant and breastfeeding women.

Fact Check

In May 2022, as the death toll from the COVID-19 pandemic surpassed 1 million in the United States, many social media users continued to sow doubt about vaccines by making a series of unfounded and untrue claims related to new documents released by the Food and Drug Administration (FDA) as part of a federal Freedom of Information Act (FOIA) request.

One of the most popular claims was that the newly released documents showed how Pfizer had lied about the vaccine being safe during pregnancy and for breastfeeding mothers. This claim was based on a screenshot that social media users falsely claimed came from the new documents. In reality, this screenshot shows a portion of a page published by Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) in December 2020. While the screenshot accurately showed the MHRA’s assessment at the time, health officials in Britain have since determined that the vaccines are safe for both pregnant and breastfeeding mothers.

Text, Paper, Page

The pictured passage does not come from the newly released Pfizer docs but from a page on the MHRA website. More importantly, while the MHRA did once state that the “COVID-19 mRNA Vaccine … is not recommended during pregnancy,” this warning was issued in December 2020, just as the vaccines were being released. The agency has since revisited and removed this warning.

On April 30, 2021, the FDA released an analysis of adverse events related to the COVID-19 vaccine in response to a FOIA request by the group Public Health and Medical Professionals for Transparency (PHMPT). While we found a few mentions of breastfeeding and pregnancy in this document, the above-displayed screenshot does not come from this report.

The advice in this screenshot can be seen in an archive version of the MHRA website on Dec. 8, 2020. A month later, as health agencies learned more about the effects of the vaccine, the MHRA revised this section to remove the recommendation to pregnant women to not to get vaccinated. The MHRA revised this language to state that the administration of the COVID-19 vaccine in pregnancy “should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.”

A spokesperson for the agency told Reuters:

This was our assessment at the time of approval for the vaccine … 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.

This screenshot also is not evidence that Pfizer was “hiding” or “lying” about the vaccine’s effect on pregnant women because the screenshot does not come from Pfizer documents. If this screenshot is evidence of anything, it’s that health officials were cautious and concerned about safety when these vaccines were being rolled out. They didn’t immediately recommend the vaccines for pregnant women, but waited until they were confident that the benefits of taking the vaccines greatly outweighed any risks.

Vaccines Are Safe for Pregnant Women

In sum, this rumor is based on years-old health advice that has since been revised. As of this writing in May 2022, health officials recommend pregnant women get the COVID-19 vaccine.

The Center for Disease Control and Prevention (CDC) writes:

COVID-19 vaccination is recommended for people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future. In addition, everyone who is eligible, including those who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future, should get a booster shot and stay up to date with their COVID-19 vaccines. If you have questions about getting vaccinated, talking with your healthcare professional might help, but is not required.


Sources:

CDC. “Pregnant and Recently Pregnant People.” Centers for Disease Control and Prevention, 3 Mar. 2022, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/pregnant-people.html.

“Claim by Mercola That the Pfizer-BioNTech COVID-19 Vaccine Causes Immunosuppression Is Inaccurate, Misrepresents Study’s Findings.” Health Feedback, 21 Apr. 2022, https://healthfeedback.org/claimreview/mercola-pfizer-biontech-covid-vaccine-immunosuppression-inaccurate-misrepresents-study/.

Commissioner, Office of the. “FDA Approves First COVID-19 Vaccine.” FDA, 23 Aug. 2021, https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.

“Fact Check-Screenshots Do Not Show Pfizer Declaring Vaccines Unsafe.” Reuters, 5 May 2022. www.reuters.com, https://www.reuters.com/article/factcheck-covid19-vaccines-women-idUSL2N2WX1IL.

“Information for Healthcare Professionals on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174).” GOV.UK, https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-healthcare-professionals-on-pfizerbiontech-covid-19-vaccine. Accessed 6 May 2022.

McDonald, Jessica. “Posts Misinterpret Pfizer COVID-19 Vaccine Safety Monitoring Document.” FactCheck.Org, 18 Mar. 2022, https://www.factcheck.org/2022/03/scicheck-posts-misinterpret-pfizer-covid-19-vaccine-safety-monitoring-document/.

“PolitiFact – Pfizer Did Not ‘Hide’ Hiring of 2,400 People to Handle Expected Increase of Vaccine-Related Health.” Politifact, https://www.politifact.com/factchecks/2022/may/05/one-america-news/pfizer-did-not-hide-hiring-2400-people-handle-expe/. Accessed 6 May 2022.

“What ‘Pfizer Documents’ Release Reveals.” Newsweek, 5 May 2022, https://www.newsweek.com/pfizer-documents-vaccine-deaths-1703869.