FOI release

Freedom of Information request on COVID-19 Vaccine Liability (FOI 20-532)

Published 24 March 2021

Thank you for your email of 05 December 2020, where you asked several questions concerning the Pfizer/BioNTech COVID-19 vaccine. Please see below the response from the MHRA to each of your questions in red:

1) I would like to know what the indemnity/ liability clauses are with the vaccine that is to be rolled out this month. Furthermore I would also like to know who is liable for any adverse side effects that occur. The MHRA holds no information on this. We recommend that you contact NHS England for this information, their contact details are provided below:

2) I would also like to know why Pfizer and the NHS staff administering the doses required full indemnity? The MHRA holds no information on this. We recommend that you contact NHS England for this information, their contact details are provided below:

3) What trials/ stages of vaccine development have either not been completed in full (as they would with other vaccines), or have had a much less stringent testing process? The approval for use of the Pfizer/BioNTech COVID-19 vaccine 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.

The approval for use of the vaccine was done using a regulatory process known as a ‘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 COVID-19 mRNA Vaccine BNT162b2 batches, based on the safety, quality and efficacy data submitted by Pfizer/BioNTech to The MHRA.

A Public Assessment Report (PAR) has been published, which consists of the non-confidential aspects of The MHRA’s assessment of this vaccine, and this gives further information on the extensive testing performed in connection with the vaccine development. A link to the MHRA PAR is provided below: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19

As with any vaccine that is newly granted in the UK, studies are ongoing and all patients administered this vaccine during the clinical trials are being suitably followed up following vaccine administration.

4) Can I have a full list of vaccine ingredients, including their uses and side effects. (I would also like to know how each chemical interacts with eachother as they could be harmless on their own but react badly when they interact with eachother). A full list of ingredients in the Pfizer/BioNTech COVID-19 vaccine and the possible undesirable effects with administration of the vaccine are available in the Information for Healthcare Professionals and the Information for Recipients of the Pfizer/BioNTech COVID-19 vaccine. Links to these documents are provided below: Reg 174 information for UK healthcare professionals Package leaflet: Information for the recipient

To date, there is no evidence of the vaccine ingredients reacting with each other to cause any undesirable effects.

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: [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.

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 020 3080 6000