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

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

The Medicines and Healthcare products Regulatory Agency (MHRA) does not intend to publish these questions, or any subsequent responses received from the manufacturers. It is routine practice for regulatory authorities to ask developers of new medicines and vaccines a series of technical questions based on their data submissions. These technical discussions can cover a range of issues, including commercially confidential issues such as manufacturing methods, and as such they are not published. However, the final outcome of the assessment, including a comprehensive summary of evidence for quality, safety, and efficacy, is published in the form of a Public Assessment Report, which has been published on the GOV.UK website, and 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

We recognise that there is a public interest in the disclosure of commercial information

relating to the authorisations of the COVID-19 vaccines following the COVID-19 pandemic.

Due to the technical context of the 36 questions posed to Pfizer and BioNTech and any response that they may have issued, disclosure of such correspondence would risk compromising an existing competitive market environment, which would harm the reputation of the MHRA amongst pharmaceutical manufacturers and potentially disincentivise them from seeking an authorisation for the United Kingdom for highly beneficial new medicines or medical devices.

To ensure the accuracy of redactions within the minutes in question the Medicines and Healthcare products Regulatory Agency (MHRA) has temporarily withdrawn the meeting minutes of the Vaccine Benefit Risk Expert Working Group to ensure accurate and transparent records.

The MHRA anticipates republishing all minutes as soon as possible.

For further transparency, when the minutes are republished, an alert will be sent to all subscribers who have registered for updates to the GOV.UK website for content of this type. I have also asked the rt hon member is alerted.

It is routine practice for regulatory authorities to ask developers of new medicines and vaccines technical questions based on their data submissions. These technical questions can cover a range of issues, including commercially confidential issues such as manufacturing methods, and they are not published.

The final outcome of the assessment, including the comprehensive summary of the evidence for quality, safety and efficacy, is published in the form of a Public Assessment Report, 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

The Medicines and Healthcare products Regulatory Agency does not intend to publish these questions, or any subsequent responses received from the manufacturers.

The study abstract has been reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA), as part of its continuous post approval safety monitoring procedures for the Pfizer-BioNTech COVID-19 Vaccine (Comirnaty). The abstract is available at the following link:

https://catalogues.ema.europa.eu/system/files/2024-06/C4591021%20Interim%205%20Study%20Report%20Abstract%20_0.pdf

The MHRA does not consider that any regulatory action is warranted at this time and will review the final study report, when it’s made available by Pfizer, as part of safety monitoring procedures.

The MHRA does not publish study reports for company studies, and further publications of results are the responsibility of Pfizer-BioNTech. The MHRA continues to closely monitor the safety of all COVID-19 vaccines and will take any regulatory action necessary should any new safety concerns be identified.

All COVID-19 vaccines deployed in the United Kingdom have been authorised for use following a rigorous review by the independent regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA continuously monitors safety during the widespread use of a vaccine. It keeps all available evidence under review, including studies, published literature and data arising from usage in the UK and internationally, including the article referenced. The MHRA communicates safety advice based upon the totality of evidence rather than the strengths and limitations of individual data sources.

No vaccine would be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) unless it meets our stringent standards of safety, quality and effectiveness.

The MHRA keep all available evidence under review including studies, published literature and data arising from the widespread use in the United Kingdom and globally including the article highlighted. The MHRA communicates safety advice based upon the totality of evidence rather than the strengths and limitations of individual data sources.

The MHRA position is that the benefits of these vaccines in preventing serious complications associated with COVID-19 continue to outweigh the known risks for the majority of individuals. A summary of the MHRA’s safety review is available at the following link:

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

The MHRA publishes a breakdown of reports received by seriousness on the Yellow Card website, however it is not possible to calculate seriousness rates from this data.

A vaccine will not be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) unless it meets stringent standards of safety, quality and effectiveness.

The MHRA continuously monitors safety during widespread use of a vaccine. As part of this monitoring role MHRA keeps all available evidence under review, including studies such as the one referenced, published literature and data on vaccine use in the United Kingdom and globally. The MHRA’s position is that the benefits of these vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects in the majority of patients. A summary of side-effects reported to MHRA under their Yellow Card reporting system after vaccination with COVID vaccines is available at the following link:

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

We are not able to disclose details of commercially sensitive contracts between the Government and vaccine manufacturers while negotiations are ongoing.