some people on Twitter have claimed that the UK government has stopped recommending the Covid-19 vaccine for pregnant and breastfeeding women. This is not true.
IN a tweet which has over 7,500 retweets, ex-footballer Matt Le Tissier said: “So after two years the government has changed its recommendations now claiming that those who are pregnant or breastfeeding should not get the Vax. Too little too late for some.”
This is not true. The NHS still recommends that you get vaccinated against Covid-19 if you are pregnant or breastfeeding.
The claims were also shared on Facebook.
Where do these claims come from?
A Twitter user said there had been a “twist” and pointed to a document he claimed was “quietly published in August”.
That document, which some tweets includes screenshots of, there is a section at the end titled “Toxicity Conclusions” which states that “it is considered that sufficient assurance for the safe use of the vaccine in pregnant women cannot be provided at the present time” and “women who breastfeeding should also not be vaccinated”.
Although it adds: “These judgments reflect the lack 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 (RAP) [for the Pfizer Covid-19 vaccine] which reflects our assessment at the time of approval of the vaccine”.
The MHRA approved the Pfizer vaccine for use in the UK in December 2020, which is also when the documents were first published. The section detailing the lack of evidence for safe use in pregnant and breastfeeding women has been up since at least December 2020.
In April 2021, the Joint Committee on Vaccination and Immunization advised that pregnant women should be offered the Covid-19 vaccine at the same time as their age group.
The MHRA added: “New data (non-clinical and post-authorisation ‘real-world’ data) has since come to light which supports updated advice on vaccinating those who are pregnant and breast-feeding.
“Our latest advice can be found in our summary of the yellow card vaccine COVID-19 report, which says the vaccines are safe to use during pregnancy and breast-feeding.”
Viki Male, an immunologist at Imperial College London who works on pregnancy, tweeted it The document “only describes 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 women and find no No problem”.
In other words, this is an old document, from before there was a lot of real data that the vaccine was safe for pregnant women.
Confusion updates
The document says it was “updated on August 16, 2022,” which seems to have caused some confusion with people thinking it was just published. This document itself does not appear to have been updated, but is part of a set of documents related to the regulatory approval of the Pfizer vaccine, which contains another document that has been updated.
The MHRA told Full Fact that the August 16 update “refers to changes made to the Summary of Product Characteristics and Patient Information Leaflet, which are on the same page as the Public Assessment report”.
On the MHRA website titled “Regulatory approval of Pfizer/BioNTech vaccine for COVID-19” (which links to the Public Assessment report document people have shared) there is a section that says “show all updates”. It says the updates on August 16 “included information about receiving ea [different brand of vaccine for the] booster doses in individuals aged 18 years and older”. It does not mention anything about safety in pregnancy.
A representative of Mr. Le Tissier told Full Fact: “It has been widely reported that the information is confusing” and that “the real question is why is it stating it on the government’s website and how confusing are these instructions”.
The vaccine against Covid-19 is recommended for both pregnant and lactating women
As we wrote before, the vaccine against Covid-19 is recommended in all stages of pregnancy. The Royal College of Obstetricians and Gynecologists says the vaccine is “the best way to protect against the known risks of COVID-19 in pregnancy for both women and babies, including the woman’s admission to intensive care and the premature birth of the baby.” “.
The Royal College of Midwives warns that pregnant women are “more at risk of becoming seriously ill if they catch [Covid-19] virus” and thus “getting the vaccine is the best way to protect yourself and your child from the effects of COVID-19”.
It is true that when the Pfizer vaccine was first approved for use in the UK, the advice was that pregnant and breastfeeding women should not take 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 sufficient to provide meaningful data on safety during pregnancy.
But since then many studies, as described 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.
In addition, the safety of vaccines during pregnancy continues to be monitored through the Yellow Card scheme, which allows anyone to report a suspected reaction or side effect after a vaccine, even if they do not 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 reaction to these vaccines, increases the risk of miscarriage or stillbirth”.
It adds: “The MHRA will continue to closely monitor the safety data on the use of COVID-19 vaccines in pregnancy, including the evaluation of electronic health care records.”
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