FOI release

Freedom of Information request about the authorisation of the Pfizer/BioNTech and the Oxford/AstraZeneca vaccines was done through an expedited rolling review (FOI-21-309)

Published 28 May 2021

The authorisation of the Pfizer/BioNTech and the Oxford/AstraZeneca vaccines was done through an expedited rolling review. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The temporary authorisation under Regulation 174 permits the supply of identified vaccine batches, based on the safety, quality and efficacy data submitted to MHRA. These authorisations do not constitute a marketing authorisation.

All vaccines are tested through three phases of clinical trials to ensure they meet the gold standard. Phase 1 trials are with a small group of people to make sure there are no safety concerns and determines the appropriate dosage for the best immune response. Phase 2 trials are conducted on a larger group of people to check the vaccine works consistently and that the immune response is sufficient. Phase 3 trials test the vaccines on thousands of people for scientists to assess if the vaccine is producing immunity that will prevent disease. Usually, these phases are run in sequence, but in an effort to find a safe and effective Covid-19 vaccine as quickly as possible, once safety has been ascertained through Phase 1, Phases 2 and 3 are being run in parallel. Extensive checks and balances are required at every stage of the development of a vaccine, and this is no different for a Covid-19 vaccine. No stages in the vaccine development processes were bypassed.

Information on the study conducted using the Pfizer/BioNTech vaccine and its results are available in a peer-reviewed journal, the New England Journal of Medicine. Details include patient demographics, including concomitant illnesses that recipients of the vaccine presented. A link to this is provided below:

https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home

The approval for use of the Pfizer/BioNTech and Oxford/AstraZeneca COVID-19 vaccines in the UK followed a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine, and also considered the conditions for its safe supply and distribution. The decision was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. Regarding the MHRA approval of the Pfizer/BioNTech and the Oxford/AstraZeneca COVID-19 vaccines, further information (including information for physicians and recipients of the vaccine, and Public Assessment Reports [PARs] for each vaccine) are available on the MHRA website. Links to these are provided below:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca

Further to the above, the Moderna vaccine has also been authorised for use. Further information on this is provided below:

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

The MHRA collect reports of suspected adverse reactions to all medicines and vaccines via the Yellow Card scheme. All reports are continually reviewed to detect possible new side effects that may require regulatory action, and to differentiate these from things that would have happened regardless of the vaccine or medicine being administered, for instance due to underlying or undiagnosed illness.

Since the launch of the COVID-19 immunisation campaign we have been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at population level. Our adverse reaction assessment report can be found here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

Throughout this global pandemic, we have always been guided by the latest scientific advice. Having studied evidence on both the Pfizer/BioNTech and Oxford/AstraZeneca vaccines, the Joint Committee on Vaccination and Immunisation (JCVI) has advised that we should prioritise giving as many people in at-risk groups their first dose, rather than providing two doses in as short a time as possible.

The four UK Chief Medical Officers agree with JCVI that at this stage of the pandemic prioritising the first doses of vaccine for as many people as possible on the priority list will protect the greatest number of at risk people overall in the shortest possible time and will have the greatest impact on reducing mortality, severe disease and hospitalisations and in protecting the NHS and equivalent health services.

This is because the evidence shows that one dose of either vaccine provides a high level of protection from Covid-19.

For both vaccines, data provided to MHRA demonstrate that whilst efficacy is optimised when a second dose is administered both offer considerable protection after a single dose, at least in the short term. For both vaccines the second dose completes the course and is likely to be important for longer term protection.

The NHS across the UK will prioritise giving the first dose of the vaccine to those in the most high-risk groups. Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer-term protection.

The JCVI’s independent advice is that this approach will maximise the benefits of both vaccines allowing the NHS to help the greatest number of people in the shortest possible time. It will ensure that more at-risk people are able to get meaningful protection from a vaccine in the coming weeks and months, reducing deaths and starting to ease pressure on our NHS.

For further information on prioritising the first COVID-19 vaccine dose see the statement from the Joint Committee on Vaccination and Immunisation (JCVI). This information includes the rationale and evidence for prioritising the first dose.

Regarding your request for the data submitted to MHRA and MHRA’s requests for further information for each vaccine during the timepoints stated, this information is exempt from release under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the Freedom of Information (FOI) Act.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in providing information that can be used by competitors for their commercial advantage. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: [email protected] 

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.

After that, if you remain dissatisfied, you may write to the Information Commissioner at; The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire

SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU.