The UK Health Security Agency (UKHSA) procures vaccines that have been approved by the Medicines and Healthcare products Regulatory Agency and are advised for use in COVID-19 booster programmes by the Joint Committee on Vaccination and Immunisation (JCVI). The make-up of vaccine availability can vary from campaign to campaign based on the latest JCVI and clinical advice and procured stock available.

Published advice in the COVID-19 Green book, chapter 14a recommends that those with known contraindications to COVID-19 vaccination should seek advice from a relevant specialist. This may include an allergy specialist, who can make a clinical assessment of the individual's risks and benefits of vaccination. If suitable, these individuals may be advised to be vaccinated in hospital under medical supervision.

During the 2025 Spring COVID-19 vaccination campaign, UKHSA did not receive any reports of supply issues in North Northumberland.

Vaccine deployment is managed by NHS England which works with the regional teams and integrated care boards to ensure the vaccine is readily available for those eligible, as per the JCVI advice. UKHSA has worked and continues to work with all deployment partners to ensure the supply and provision of vaccines.

The spring 2025 campaign will continue to use mRNA vaccine supply secured under existing pandemic contracts with Pfizer and Moderna. Those eligible will be offered either Moderna or Pfizer/BioNTech vaccines during the spring 2025 campaign.

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.

All batches of the Pfizer and Moderna COVID-19 vaccines released in the United Kingdom to date have passed their release specifications for DNA levels. The specifications are set in line with their respective controlled manufacturing process and in accordance with, for example, World Health Organization guidance on the quality, safety, and efficacy of vaccines. No batches that have excessive levels of residual DNA have been released.

The Government is guided by the advice of the independent Joint Committee on Vaccination and Immunisation (JCVI) for its immunisation and vaccination programmes. This includes eligibility for vaccination and the vaccines that may be used in the national programme.

Both the Moderna mRNA (Spikevax) COVID-19 vaccine and the Pfizer-BioNTech mRNA (Comirnaty) COVID-19 vaccine are approved for use in the United Kingdom and, in line with JCVI advice, may be used in the autumn 2024 COVID-19 national vaccination programme. NHS England advises that all sites in Ashfield are currently providing the Moderna vaccine, and that from November 2024 the Pfizer vaccine is also expected to be supplied. The vaccine or vaccines being supplied at individual sites or nationally is, within JCVI guidance, an operational matter. Further information on the JCVI’s advice is available at the following link:

https://www.gov.uk/government/publications/covid-19-autumn-2024-vaccination-programme-jcvi-advice-8-april-2024/

Guidance from the UK Health Security Agency (UKHSA) states that there are very few individuals who cannot receive the COVID-19 vaccines approved in the UK. Anyone concerned about possible reactions to a vaccine should in the first instance speak to the clinician responsible for their care for advice.

Published UKHSA clinical guidance for health professionals and immunisation practitioners on COVID-19 vaccination includes guidance for the management of patients with a history of allergy, including circumstances where a person may be referred to an expert allergist and, after a review of the individual’s risks and benefits of vaccination, where it is indicated, they could then be vaccinated in hospital under clinical supervision. NHS England will continue to follow this clinical guidance.

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.

Following the initial roll out of the COVID-19 vaccination programme in December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) had a comprehensive surveillance strategy in place, enabling continual close monitoring of emerging safety evidence including studies, published literature, and data arising from the widespread use in the United Kingdom and globally. This included the article and Norwegian reports highlighted. The MHRA communicates safety advice based upon consideration of the totality of evidence from all relevant information sources, rather than the strengths and limitations of individual data sources.

The primary aim of the COVID-19 vaccination programme continues to be the prevention of severe disease, namely hospitalisation and death, arising from COVID-19. The Joint Committee on Vaccination and Immunisation (JCVI) has recommended a targeted approach to COVID-19 vaccination focussed on those most vulnerable from COVID-19, including older individuals and individuals with specified existing clinical conditions.

On 8 August 2023, the Government accepted advice from the JCVI on who should be offered a COVID-19 vaccine in the autumn 2023 booster programme. This includes residents in a care home for older adults, all adults aged 65 years old and over, persons aged six months to 64 years old in a clinical risk group, frontline health and social care workers, persons aged 12 to 64 years old who are household contacts and persons aged 16 to 64 years old who are carers. For the autumn 2023 campaign, the JCVI have advised the Pfizer-BioNTech mRNA monovalent XBB vaccine for use in individuals from six months old and the Pfizer-BioNTech mRNA (Comirnaty) bivalent Original/Omicron BA.4-5 vaccine for use in individuals aged 12 years old and over. All individuals who are currently eligible for COVID-19 vaccination are therefore eligible to receive a Pfizer COVID-19 vaccine. There are no plans to expand the eligibility criteria for the autumn campaign. The JCVI will continue to review evidence and will provide further advice regarding future vaccination programmes in due course.

The JCVI has advised that further vaccination doses provide additional protection from serious outcomes from COVID-19. Whilst natural immunity alone provides good levels of protection against severe COVID-19, the combination of natural and vaccine-induced immunity, also known as hybrid immunity, is associated with even higher levels of protection.

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.