UK confusing vaccination guidelines

Green book, JCVI advises that breastfeeding women should be offered any suitable COVID-19 vaccine.

(Updated, 17th August, 2022)

Summary of the Public Assessment Report. For covid-19 vaccine, Pfizer/BioNTec

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 & BioNTech Manufacturing, GmbH

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

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).

Developmental and reproductivity testing of the Pfizer BioNTech, Moderna and AstraZeneca vaccines in animals have not raised any concerns.

JCVI has therefore advised that women who are pregnant should be recommended to receive primary immunisation,

and that pregnancy is considered a clinical risk group for the autumn booster programme.

Routine questioning about last menstrual period and/or pregnancy testing is not required before offering the vaccine.

Surveillance of the inadvertent administration of COVID-19 vaccines in early pregnancy is being conducted for the UK by the UK Health Security Agency Immunisation and Vaccine Preventable Diseases Division, to whom such cases should be reported.1

This surveillance is being undertaken to document safety in women who unknowingly receive a vaccine in early pregnancy

Breastfeeding

There is no known risk associated with being given a non-live vaccine whilst breastfeeding.

JCVI advises that breastfeeding women should be offered any suitable COVID-19 vaccine.