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.

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

The United Kingdom has well established systems for controlling costs and ensuring we get value for money for spending on medicines. For unbranded generic medicines the Department relies on competition to keep prices down. This has led to some of the lowest prices in Europe and allows prices to react to the market. In an international market this ensures that when demand is high and supply is low, prices in the UK can increase to help secure the availability of medicines for UK patients.

Where competition does not appear to be working, the Department alerts the Competition and Markets Authority (CMA). Where the CMA finds that a company has breached competition law by charging excessive prices it can impose a fine as well as order companies to reduce their prices. In those instances, the Department will seek damages and invest that money back into the National Health Service. Investigations and infringements decisions by the CMA are publicly available on the CMA’s website.

A copy of the table and documents that gives the clinical data which was submitted in relation to condition 7 will be deposited in the Libraries of both Houses.

We remain in regular discussion with Moderna and Pfizer/BioNTech on future COVID-19 vaccine supply. We are unable to provide the information requested on costing, as it is commercially sensitive. Moderna and Pfizer/BioNTech continue to negotiate vaccine deals with countries across the world and their ability to negotiate and compete is contingent on pricing information being kept confidential.

It is standard practice for contractual disputes to be settled under the International Chamber of Commerce’s Rules of Arbitration.

We are unable to provide the information requested as it is commercially sensitive.

The granting of a full Marketing Authorisation for one product does not affect the Conditional Marketing Authorisations (CMA) of others. CMAs are used for products which prevent or treat serious and life-threatening diseases where no satisfactory treatment methods are available or where the product offers a significant therapeutic advantage. The Medicines and Healthcare products Regulatory Agency may grant a CMA where comprehensive clinical data is not yet complete although it is judged that such data will become available shortly.

Prior to the planned submission date, Pfizer-BioNTech advised the Medicines and Healthcare products Regulatory Agency (MHRA) that there had been delays in obtaining the data for the report and requested an extension. The MHRA assessed any potential risk to public health and considered the significant post-marketing safety data already available from the use of the Comirnaty vaccine in children, which did not indicate any new safety concerns in this age group. An extension was agreed and the MHRA continues to monitor the safety of Comirnaty in children and adults through its surveillance strategy and will act promptly to protect public health, should any new safety concerns arise.

We are unable to provide the information requested as it is commercially sensitive. However, the Government has ensured that the supply agreements for COVID-19 vaccines provide access to updated vaccines, such as the bivalent mRNA vaccines deployed during the current booster vaccination campaign.

Indemnities do not affect the routes available to an individual to pursue a legal claim against the manufacturer. It establishes that in certain circumstances, one party to the agreement will pay the other party’s losses arising from a claim.

Regulation 345 of the Human Medicines Regulations 2012 provides partial immunity from civil liability for suppliers when there is a temporary authorisation in place to supply a product under regulation 174. Supply of the vaccine was authorised under regulation 174 as a temporary measure before the Medicines and Healthcare products Regulatory Agency granted the conditional marketing authorisation. This partial immunity would only have applied in relation to the product supplied under the regulation 174 authorisation. It would not have applied in relation to the product that was authorised by the Conditional Marketing Authorisation. And the grant of a full Marketing Authorisation would not affect any partial immunity under the Regulations.

There are still conditions to be met for the bivalent Comirnaty products, where currently the target resolution dates are before the end of 2023. There are also post-approval measures relating to drug safety monitoring through the pharmacovigilance process, as for all licensed products on the market.

The Commission on Human Medicines considered that, based on the large body of clinical data now available on these vaccines from clinical trials and real-world experience, the safety profile and efficacy of the products are now considered comprehensively characterised and meet the requirements for conversion to a full Marketing Authorisation and that the remaining conditions could therefore be downgraded to Risk Management Plan or Post-Authorisation Measures. On 9 November, the Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection line extension application was also licensed and has a full Marketing Authorisation.

The following table shows the cumulative conditions during the Conditional Marketing Authorisations.

By the conversion of the Conditional Marketing Authorisations to full Marketing Authorisations, these conditions were all met with the exception of ‘6’ and ‘8’, which were converted to Risk Management Plan measures. Condition ‘9’ was converted to a Post-Authorisation Measure with an extension until 31 December 2022 to submit the data.

The post-authorisation conditions relating to any Conditional Marketing Authorisations (CMA) are only removed from the licence once these conditions have been met and a full Marketing Authorisation (MA) could then be considered. Where clinical studies are continuing, companies will update to the regulatory authorities through post-authorisation measures.

As there are no further specific obligations, the status changed from CMA to MA for the following Comirnaty products on 9 November 2022:

- Comirnaty 30 micrograms/dose Concentrate for Dispersion for Injection (PLGB 53632/0002);

- Comirnaty 30 micrograms/dose Dispersion for Injection (PLGB 53632/0004); and

- Comirnaty 10 micrograms/dose Concentrate for Dispersion for Injection (PLGB 53632/0006).

Following its initial findings in June 2021, the FDA issued a subsequent statement confirming that after detailed analysis, these events were not found to occur more frequently in the elderly people who received the Pfizer COVID-19 vaccine.

In general, the Conditional Marketing Authorisation (CMA) is valid for one year, where the Medicines and Healthcare products Regulatory Agency will evaluate whether the company has addressed the post-authorisation measures and CMA commitments. If this has been sufficiently addressed, the CMA can be converted to a full Marketing Authorisation (MA).

Where commitments need to be addressed, the CMA may be extended for further year before the conversion to a full MA can take place. It is not expected that there will be any major implications for patients from a change in the status of the Comirnaty vaccine’s authorisation.

The NHS.UK vaccination schedule sets out which vaccinations individuals are eligible to receive through the National Health Service, including COVID-19. However, the schedule does not specify which specific COVID-19 vaccine will be used. The Government continues to be guided by the expert independent Joint Committee on Vaccination and Immunisation on the deployment of COVID-19 vaccines.

While the Joint Committee on Vaccination and Immunisation’s one-off advice for a non-urgent offer of the Pfizer vaccine in this age group was publicised on NHS.UK to raise awareness, it does not reflect a change in policy.

COVID-19 vaccination is not included in the UK Health Security Agency’s routine childhood immunisation schedule, which provides immunisation information for health professionals and immunisation practitioners.

There are no Covid-19 vaccines for under 5s currently approved for use in the UK, and as such we have not specifically procured vaccines for this cohort. The Government will continue monitoring developments and seek the advice of the Joint Committee on Vaccination and Immunisation going forward.

There are no Covid-19 vaccines for under 5s currently approved for use in the UK, and as such we have not specifically procured vaccines for this cohort. The Government will continue monitoring developments and follow the advice of the Joint Committee on Vaccination and Immunisation going forward.

We are not able to disclose the details of some clauses of contracts between the Government and vaccine manufacturers as this information is commercially sensitive.

We are not able to disclose specific costs of individual vaccines procured to date, as details of contracts between the Government and vaccine manufacturers are commercially sensitive.

An updated interim clinical commissioning policy on the use of neutralising monoclonal antibody treatments and antivirals for non-hospitalised patients with COVID-19 was agreed by the United Kingdom Chief Medical Officers on 27 January 2022. This set out the intention to add PF-07321332+ritonavir (co-packaged as Paxlovid), manufactured by Pfizer, and remdesivir to the currently available treatment options for highest risk patients with COVID-19 from 10 February 2022.

NHS England has held webinars with stakeholders such as patient organisations, Royal Colleges, professional bodies and clinicians to support the introduction of the interim commissioning policy, with further engagement events and communications planned. Any decisions on deployment of community treatments, including Paxlovid, beyond the highest risk groups will be subject to the outcomes of the PANORAMIC study.

The role of the legal framework provided by the TRIPS Agreement has and will continue to provide innovators the confidence to invest in developing health products and technologies and to form collaborative partnerships. This is evidenced with over 300 successful voluntary licensing and technology transfer partnerships, which are contributing to the production of approximately 1.5 billion COVID-19 vaccine doses per month.

We encourage industry to continue forming voluntary licensing and technology transfer partnerships. Working with commercial partners within the existing international IP framework is the most effective way to make use of global capacity to produce life-saving medicines at pace.