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.