Dear Ministry of Health,

The January 2021 Clinical Evaluation stated: Administration of COMIRNATY in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.

Q(1) Please provide the dates and titles of all risk/benefit analyses undertaken which reviewed the data/science of risks and benefits to the pregnant mother and fetus for the primary course of injection of Comirnaty BNT162b2. This includes for those who have immunocompromised conditions and healthy women.

On 3 November 2021 the Memo 'Temporary Medical Exemptions for the COVID-19 Vaccine: COVID-19 Vaccine Technical Advisory Group (CV TAG) recommendations' stated 'Pregnancy is not a valid reason for exemption in the absence of
any of the criteria listed in the above table. Pregnancy is associated with higher
risk from COVID-19 compared to the general population and therefore this group
are a priority for vaccination.'

Q(2) As it is well known that doctors are extremely precautious and often refrain from prescribing drugs without a long safety profile, please can you provide:
(a) The latest reviews/reports/advice justifying and specifically applied as rationale for the above statement that pregnancy is higher risk, as at November 2021.
(b) The scientific literature provided to doctors between October 2021- February 2022 justifying this recommendation.

In February 2022 the CVTAG recommended that 'A booster dose of the COVID-19 vaccine should be given from 3 months after the primary course to all eligible people aged 18 years and over, including immunocompromised individuals and pregnant persons.'

Q(3) Please provide the CV-TAG reviews/reports/advice which considered the risk benefit of booster doses of Comirnaty BNT162b2 to pregnant women, including for those with immunocompromised conditions and healthy women.

Thank you

Yours faithfully,

J Bruning