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UK confusing vaccination guidelines
Description
Green book, JCVI advises that breastfeeding women should be offered any suitable COVID-19 vaccine.
Uploaded 02-09-22
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1098808/Greenbook-chapter-14A-17August2022.pdf
(Updated, 17th August, 2022)
Summary of the Public Assessment Report. For covid-19 vaccine, Pfizer/BioNTec
https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine
Women who are breastfeeding should also not be vaccinated.
(Updated, 16th August, 2022)
Summary of the Public Assessment Report
Authorisation for Temporary Supply, COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection
Department of Health and Social Care (DHSC), Pfizer Limited and BioNTech Manufacturing, GmbH
https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine
Updated, 16th August, 2022
Reproductive and developmental toxicity
Fertility and early embryonic development and embryofoetal development
A combined fertility and developmental study (including teratogenicity and postnatal investigations) in rats is ongoing.
Prenatal and postnatal development, including maternal function
No such studies have been done.
Studies in which the offspring (juvenile animals) are dosed and/or further evaluated
No such studies have been done.
Local tolerance
No such studies have been done.
The assessments made as part of the general toxicity study should suffice and a separate study is not needed.
Other toxicity studies
No such studies have been done.
Toxicity conclusions
The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to meet the ongoing urgent health need.
In principle, a decision on licensing a vaccine could be taken in these circumstances without data from reproductive toxicity studies animals,
but there are studies ongoing and these will be provided when available.
In the context of supply under Regulation 174,
it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time:
however, use in women of childbearing potential could be supported,
provided healthcare professionals are advised to rule out known or suspected pregnancy prior to vaccination.
Women who are breastfeeding should also not be vaccinated.
Green book, updated 17th August 2022
Specific population groups
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1098808/Greenbook-chapter-14A-17August2022.pdf
Pregnancy
There is no known risk associated with giving inactivated, recombinant viral or bacterial vaccines or toxoids during pregnancy or whilst breastfeeding (Kroger et al, 2013).
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