Pregnant and breastfeeding women are still advised to get the Covid-19 vaccine

31 August 2022
What was claimed

The UK government has quietly u-turned on its advice for pregnant and breastfeeding women and the Covid-19 vaccine, and now advises them not to get vaccinated.

Our verdict

The advice remains that those pregnant or breastfeeding should get the Covid-19 vaccine. The claim seems to be based on an old document, dating from when there wasn’t lots of data about the safety of the vaccine in pregnancy or during breastfeeding.

Several people on Twitter have claimed the UK government has stopped recommending the Covid-19 vaccine for pregnant and breastfeeding women. This is not true.

In a tweet that has over 7,500 retweets, former footballer Matt Le Tissier said: “So the government have after two years changed their recommendations now claiming those who are pregnant or breastfeeding should not be taking the Vax. Too little too late for some.”

This isn’t true. The NHS still recommends that you get vaccinated against Covid-19 if you’re pregnant or breastfeeding.

The claims have also been shared on Facebook.

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Where do these claims come from?

One Twitter user said there’d been a “u-turn” and pointed to a document he claimed was “published quietly in August”.

That document, which several tweets include screenshots of, has a section at the bottom titled “Toxicity conclusions” which says that “it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time” and “women who are breastfeeding should also not be vaccinated”. 

Though it does add: “These judgements reflect the absence of data at the present time and do not reflect a specific finding of concern.”

The Medicines and Healthcare products Regulatory Agency (MHRA) told Full Fact that the document “comes from the Public Assessment Report (PAR) [for the Pfizer Covid-19 vaccine] which reflects our assessment at the time of approval for the vaccine”.

The MHRA approved the Pfizer vaccine for UK use in December 2020, which is also when the documents were first published. The section which details the lack of evidence of safe use in pregnant and breastfeeding women has been live since at least December 2020.

In April 2021, the Joint Committee on Vaccination and Immunisation advised that pregnant women should be offered the Covid-19 vaccine at the same time their age group was.

The MHRA added: “Since then new data has come to light (both non-clinical and post-authorisation “real world” data) which supports the updated advice on vaccinating those who are pregnant and breastfeeding. 

“Our latest advice can be found in our summary of Yellow Card COVID-19 vaccine reporting which states that the vaccines are safe to use during pregnancy and breastfeeding.”

Viki Male, an immunologist at Imperial College London working on pregnancy, tweeted that the document “describes only the data that Pfizer submitted to the Medicines and Healthcare products Regulatory Agency, not the independently generated data we have from universities and government bodies, which track vaccine safety in more than 315,000 pregnant people and find no problem”.

In other words, this is an old document, from before there was lots of real-world data about the vaccine being safe for pregnant women.

Updates confusion

The document says it was “updated 16 August 2022”, which seems to have caused some confusion with people thinking it has only just been published. This document itself doesn’t appear to have been updated, but it is part of a group of documents concerning regulatory approval of the Pfizer vaccine, which features another document that has been updated.

The MHRA told Full Fact that the 16 August update “refers to changes made to the Summary of Product Characteristics and Patient Information Leaflet, which are found on the same page as the Public Assessment report”.

On the MHRA web page titled “Regulatory approval of Pfizer/BioNTech vaccine for COVID-19” (which links to the Public Assessment report document people have been sharing) there’s a section that says “show all updates”. This says the updates on 16 August were “to include information about receiving a [different brand of vaccine for the] booster dose in individuals aged 18 years and over”. It does not mention anything about safety in pregnancy.

A representative for Mr Le Tissier told Full Fact: “It has been widely reported that the information is confusing” and that “the real question is why does it state that on the government page and how confusing are these guidelines.”

The Covid-19 vaccine is recommended for both pregnant and breastfeeding women

As we have written before, the Covid-19 vaccine is recommended at all stages of pregnancy. The Royal College of Obstetricians and Gynaecologists says that the vaccine is “the best way to protect against the known risks of COVID-19 in pregnancy for both women and babies, including admission of the woman to intensive care and premature birth of the baby”.

The Royal College of Midwives warns that pregnant women are “more at risk of becoming seriously unwell if they catch the [Covid-19] virus” and so “getting the vaccine is the best way to protect yourself and your baby from the effects of COVID-19”.

It’s true that when the Pfizer vaccine was first approved for use in the UK, the advice was for pregnant and breastfeeding women not to get it. Pregnant women were excluded from the initial large trials for the Pfizer, AstraZeneca and Moderna vaccines and the 57 unintended pregnancies during the trials were not enough to give meaningful data on safety during pregnancy. 

But since then many studies, as outlined in this review, have confirmed that Covid-19 is safe and is associated with a reduction in stillbirths. And from April 2021, pregnant women in England were advised to get the Pfizer or Moderna vaccine.

On top of this, the safety of vaccines in pregnancy continues to be monitored via the Yellow Card scheme, which allows anyone to report a suspected reaction or side effect following a vaccine, even if they don’t know it was caused by the vaccine. 

According to the MHRA which runs the scheme, “There is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK, or any reactions to these vaccines, increase the risk of miscarriage or stillbirth.”

It adds: “The MHRA will continue to closely monitor safety data for use of the COVID-19 vaccines in pregnancy, including through evaluation of electronic healthcare record data.”

Image courtesy of freestocks

We took a stand for good information.

After we published this fact check, the MHRA added a banner to its Public Assessment Report to make it clear that it summarises the initial assessment at the time of approval in December 2020 and the text in the original report remains unchanged. It contains a link to the latest advice based on significant new data since then. 

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