By: Laura Vitelli
September 2 2022
The claims being shared across social media are based on a misinterpretation of a U.K. Government page hosting a now-outdated document by the MHRA.
Recent social media posts claim that the U.K. government has quietly 'u-turned' regarding safety guidelines for the Pfizer-BioNTech COVID-19 vaccine's use on pregnant and breastfeeding women. These posts usually link to a page from the blog of Professor Norman Fenton, who specializes in Risk Information Management at the Queen Mary University of London. In the blog post, Fenton discusses a document taken from the U.K. government website that appears to state that "sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided "at the present time" and takes this to mean that the U.K. government has been publicly recommending health advice contrary to official guidelines.
These claims originate from a misreading of an 'updated' notice at the top of a page on the U.K. government's Medicines and Healthcare products Regulatory Agency (MHRA) site. This page contains the 2020 Public Assessment Report for the Pfizer-BioNTech COVID-19 vaccine, which shares information about the vaccine's regulatory approval.
The 'updated' notice refers to changes made to the "Summary of Product Characteristics and Patient Information Leaflet" sections of the document, which are found on the same page as the Public Assessment Report. Descriptions of all updates made to the document can be found in the "see all updates" link at the bottom of the page. The only update that mentions pregnant women was made on December 30, 2020, stating: "Updated the Information for UK recipients and the Information for healthcare professionals documents, to reflect changes to the dosage interval, advice for women who are pregnant or breastfeeding and to those with allergies."
The document in question is a report containing data submitted by MHRA when it sought emergency approval for the vaccine during the initial stages of the pandemic. The introduction states that the data in the report is based on information provided by Pfizer in a "rolling data submission procedure." This means that the data was being gathered 'live' throughout the early stages of the pandemic, and as such, there was not yet any data on how the vaccine affected pregnant women. The document was thus correct at the time of its publication in 2020, as government agencies and medical organizations are often hesitant to recommend vaccines to pregnant women when there is not enough information to assure the public of their safety.
The U.K. government has since conducted its own surveys using more recent datasets gathered by universities and government bodies, and the Pfizer-BioNTech vaccine was recommended for pregnant women from April 2021. This is why the complete, up-to-date guidelines from the MHRA state that "The COVID-19 Pfizer/BioNTech and Covid-19 Vaccine Moderna are currently the preferred vaccines for use during pregnancy and can be given at any stage in pregnancy."
The document being claimed as 'proof' of the vaccine's unsuitability for pregnant women is from 2020 and was correct at the time of its publication. There has since been plenty of data collected showing that the Pfizer-BioNTech COVID-19 vaccine is safe and effective for pregnant women. COVID-19 remains significantly more dangerous to the health of pregnant women than the vaccine. As such, we have marked the claim as false.