The newly released Pfizer documents do not show that their COVID-19 vaccine is unsafe

Beginning in late April, the Food and Drug Administration turned over thousands of documents related to its review of Pfizer-BioNTech's COVID-19 vaccine, as more than 300 million doses of the vaccine have now been administered in the US.  In a January court order, U.S. District Judge Mark Pittman of the Northern District of Texas required the FDA to release around 12,000 documents immediately, and then 55,000 pages a month until all documents are released. Already, anti-vaccine advocates have capitalized on the release of these documents to further call COVID-19 vaccines into question, coalescing around the viral hashtag #pfizerdocuments.

Many social media users are sharing screenshots of the documentation, particularly one document which states that "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" (examples here, here and here). The screenshot many users are sharing, however, shows information from Great Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) in 2020, and not documentation from Pfizer (link to the original MHRA document can be read here). MHRA has since updated its advice on vaccinating those who are pregnant and breastfeeding. Health authorities in Britain and the United States recommend COVID-19 vaccination for pregnant and breastfeeding women. The latest version can be read here.

An article by Reuters Fact Check explains how the clause ended up in the original guidelines...

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.

Another popular claim alleges that the new documents prove that the vaccine is only 12% effective at protecting from COVID-19, not the 95% that Pfizer initially reported (examples here and here). None of those making the claim, however, link to any actual documentation. The original allegation can be traced to a Substack user known as Sonia Elijah. And despite tweets presenting the alleged finding as new, the Substack article itself was published on April 3rd, weeks before these documents were shared.

The vast majority of the documents released so far have generally not been relevant to the conversation around the safety and effectiveness of the Pfizer vaccine. The truth is that many of the claims under the #pfizerdocuments trend have already been debunked, despite the emphasis by conspiracy theorists that these issues have suddenly come to light by the release of these documents. You can read more about these debunked conspiracies when it comes to the COVID-19 vaccines here, here and here.