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Why were breastfeeding women in the UK denied the covid-19 vaccine?

BMJ 2021; 372 doi: (Published 05 January 2021) Cite this as: BMJ 2021;372:n4

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  1. Helen Hare, acute medicine core medical trainee year 2,
  2. Kate Womersley, academic foundation year 2 trainee
  1. v1kwomer{at}

Absent data are not a valid justification for exclusion

On 30 December, a month after licensing the Pfizer BioNTech covid-19 vaccine, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) revised its guidance to enable pregnant and breastfeeding women to receive it. The change came after pressure from campaigners, clinicians, and affected women, including a piece we wrote for BMJ Opinion. The MHRA previously recommended that breastfeeding women be denied the vaccine, which was interpreted by NHS trusts as a blanket ban. This was at odds with the EU, US, and Canada, where women have been encouraged to make risk-benefit decisions based on their own circumstances. The MHRA’s U turn is welcome news, but why were breastfeeding women initially excluded?

If the MHRA held public advisory committee meetings like the US when assessing vaccines for emergency use applications, the rationale for their original and revised recommendations could be openly scrutinised.1 The MHRA’s initial position, which disregarded a breastfeeding woman’s level of exposure to the virus or her likelihood of developing a severe form of the disease, seemed to result from a lack of evidence. Pfizer, AstraZeneca, and Moderna vaccine trials did not enrol breastfeeding women and so no specific safety data are currently available. But absent data are rarely a valid justification for broad exclusions. Men who are trying to conceive have not been cautioned about the vaccine, even …

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