Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to paragraph 3.7 of the minutes of the Covid-19 Vaccine Benefit Risk Expert Working Group held on 18 November 2020, if he will publish the risk-based evaluation for the Pfizer/BioNTech mRNA vaccine.

The reactogenicity of vaccines refers to their capacity to produce common or “expected” adverse reactions following vaccination such as fever, tiredness, and a sore arm at the vaccination site. These reactions, and the frequency with which they occur, are listed in section four of the vaccine package leaflet, which states what possible side effects people may experience. Regarding the reference to reactogenicity in paragraph 3.19 of the minutes of the COVID-19 Vaccine Benefit Risk Expert Working Group held on 18 November 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published information for the recipients of the Pfizer/BioNTech mRNA vaccine, as well as for healthcare professionals. These documents detail the reactogenic nature of the vaccines, and are available, respectively, at the following two links:

https://assets.publishing.service.gov.uk/media/61c518a0e90e071971e2561e/Temporary_Authorisation_Patient_Information_BNT162_18_0_UK_Clean.pdf

https://assets.publishing.service.gov.uk/media/61c51662d3bf7f1f7bc0ac8b/Temporary_Authorisation_HCP_Information_BNT162_19_0_UK_Clean.pdf

The MHRA also regularly published coronavirus vaccine summaries of Yellow Card reporting throughout the pandemic. Amongst many other matters regarding the safety of the COVID-19 vaccines, the reactogenic nature of the vaccines was regularly discussed in these communications, which are available at the following link:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

Regarding paragraph 3.7 of these same minutes, the MHRA published product information for the COVID-19 vaccines on the GOV.UK website when regulatory approval was given, starting from 2 December 2020 when the Pfizer/BioNTech (Comirnaty) vaccine was the first COVID-19 vaccine in the world to be approved. On this day, the risk-based evaluation for the Pfizer/BioNTech mRNA vaccine referenced in this paragraph of the minutes was published as part of a summary of the public assessment report for the COVID-19 vaccine Pfizer/BioNTech, which is available at the following link:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine