Pregnant and breastfeeding women can take either of the two approved coronavirus vaccines “when the potential benefits outweigh the risks”, the UK’s medicines regulator said.
The Pfizer/BioNTech vaccine can also now be administered to people with a wide range of food and medicines allergies, experts said at a Medicines and Healthcare products Regulatory Agency (MHRA) briefing.
However, people allergic to ingredients in the vaccine should not take it, MHRA chief executive Dr June Raine said.
And the interval between people receiving the first and second doses of the Pfizer/BioNTech vaccine has been increased to “at least” 21 days.
Dr June Raine, MHRA chief executive, set out a series of updates for usage of the Pfizer vaccine, which was approved on December 2, in a briefing on Wednesday.
She said previous advice had not recommended its use by pregnant and breastfeeding women due to “an initial lack of evidence on a precautionary basis”.
She said: “But now that we have reviewed further data that has become available, the Commission on Human Medicines has advised that the vaccine can be considered for use in pregnancy when the potential benefits outweigh the risks, following an individual discussion with every woman.
“Women should always be discussing benefits and risks of having the vaccine with their health professional, reaching a decision together based on individual circumstances, and women who are breastfeeding can now also be given the vaccine, subject to that individual discussion.”
MHRA written guidance published on Wednesday about the Oxford/AstraZeneca vaccine, approved hours earlier, said preliminary animal studies do not indicate direct or indirect harmful effects for pregnancy, embryo-foetal development, childbirth or postnatal development.
It recommends the vaccine should only be considered for use in pregnancy when the potential benefits outweigh the potential risks for the mother and foetus.
It said it is not known whether the Oxford vaccine is excreted in human milk.
Advice by the Joint Committee on Vaccination and Immunisation (JCVI) has also been amended, the UK’s four chief medical officers said in a statement.
The JCVI now recommends that either vaccine should be considered in pregnancy where the risk of exposure to Covid-19 is “high and cannot be avoided”, or where the woman has underlying conditions heightening her risk of serious complications.
They said: “Those who are trying to become pregnant do not need to avoid pregnancy after vaccination, and breastfeeding women may be offered vaccination with either vaccine following consideration of the woman’s clinical need for immunisation against Covid-19. The UK chief medical officers agree with this advice.”
Clare Murphy, chief executive of the British Pregnancy Advisory Service, BPAS, said: “We know some women have felt forced to choose between continuing to feed their baby in the way that works best for them and receiving the vaccine and this new guidance should mean women can now make their own choices, based on their own personal circumstances and health needs.
“We also hope this updated approach, which follows that taken in other countries, will provide additional reassurance to women who find out they are pregnant shortly after receiving the vaccine.
“Unplanned pregnancy is common in the UK, but unplanned is not synonymous with unwanted – and we have been concerned that the guidance advising against use in pregnancy may cause unnecessary anxiety and result in the termination of otherwise wanted pregnancies.”
Previous MHRA advice said people with a range of allergies to food and medicines should not be given the Pfizer/BioNTech vaccine.
Dr Raine said growing evidence from a pool of at least 800,000 people in the UK and probably 1.5 million people in the US who have had the vaccine has “raised no additional concerns”.
This, she continued, “gives us further assurance that the risk of anaphylaxis can be managed through standard clinical guidance and an observation period following vaccination of at least 15 minutes.
“And so the Commission on Human Medicines has now advised that anyone with allergy to food or other medicine or vaccine can have the Pfizer/BioNTech vaccine.
“Of course, anyone with a history of allergic reaction to this vaccine, or its ingredients, should not.”