FOI release

Freedom of Information request on Disclosure log request, Information Request - FW: Ref: NIC-423502-R0S5X (FOI 21-039)

Published 24 March 2021

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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. 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 recently 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 following Department of Health and Social Care (DHSC) webpage for the independent report ‘Optimising the COVID-19 vaccination programme for maximum short-term impact’ from the Joint Committee on Vaccination and Immunisation (JCVI) provides the rationale for the government’s implemented dosing strategy:

https://www.gov.uk/government/publications/prioritising-the-first-covid-19-vaccine-dose-jcvi-statement/optimising-the-covid-19-vaccination-programme-for-maximum-short-term-impact

Further, the scientific basis from the JCVI concerning the current evidence on efficacy after single doses of the Pfizer/BioNTech, Oxford/AstraZeneca and Moderna vaccines is provided below:

https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAttachment.aspx?Attachment_id=103741

The list of ingredients, including the active substance and the excipients, are available in Section 2 and Section 6.1 of the Information for Healthcare Professionals, which can be accessed for each vaccine via the links above. Neither the Pfizer nor the AstraZeneca vaccine contain any ingredients of animal origin. For the Pfizer vaccine, a component derived from cow’s milk is used within an early stage of the manufacturing process of the active ingredient, but that component is not actually present in the final vaccine. There are no components of human origin present. For the AstraZeneca vaccine, materials of animal and human origin are used in the manufacturing process of the active ingredient, but these materials are not actually present in the final vaccine.

Regarding your request for all the Phase III data submitted to MHRA for the grant of these vaccines, as no marketing authorisation has been granted for any of these vaccines, this information is exempt 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 would consider the release of this information to be an actionable breach of confidence. Section 43 is a qualified exemption and requires that we consider the public interest. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in releasing information that would give competitors commercial secrets that would aid the development of their own products and/or help them overcome regulatory hurdles. MHRA’s assessment of each vaccine’s efficacy and safety is available in the PAR, a link to this is provided above. Additionally, data from the clinical studies conducted for the Pfizer/BioNTech vaccine are available in the New England Journal of Medicine, also linked above.

MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes, including the Yellow Card scheme. The MHRA, together with independent expert advice from the Commission on Human Medicines (CHM), is responsible for ensuring that the overall balance of benefits in terms of effectiveness, and risks of medicines and vaccines is positive at the time of licensing and remains so thereafter. Any emerging evidence relating to possible risks associated with medicines and vaccines, would be carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

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

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

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

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000