FOI release

Freedom of Information request on was any clinical trials data from outside the UK submitted and used for approving the Pfizer-BioNtech Covid-19 Vaccine for use in UK? (FOI 21/1258)

Published 31 May 2022

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FOI 21/1258

23rd December 2021

Dear,

Thank you for your email.

Please find our responses to your queries below.

  1. Was any clinical trials data from outside the UK submitted and used for approving the Pfizer-BioNtech Covid-19 Vaccine for use in UK? By outside UK, I mean  clinical trial sites in EU or USA. If so, please list these. If not, explain why not.

This information is available in the public domain already. The UKPAR for the Pfizer/BioNTech vaccine gives a breakdown by country of patients randomised in each country. A link to this is provided below:

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

The PAR published by the EMA also has a breakdown of the countries and number of study sites in each. A link to this is provided below:

https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

  1. The Pfizer website indicates that there were 69 clinical trial sites across the UK involving a total of 977 patient subjects  in clinical trials of the Pfizer-BioNtech Covid-19 vaccine. Is this correct and were these the only sources of clinical trials data submitted for approving the Pfizer-BioNtech Covid-19 Vaccine for UK (Emergency authorisation)? If not, please list the additional clinical trial data sources.

We refer you to the PARs (linked above) where for a list of clinical trial sources, the countries that were involved are stated and the number of centres in each.

  1. Did either MHRA or related body carry out full inspection and due diligence at all clinical trial sites in UK involved in clinical trials of the Pfizer-BioNtech Covid-19 vaccine, in order to ensure compliance with clinical trials procedures, identify any deviations from clinical protocols, or any data integrity issues, as described in the report by Paul Thacker in the British Medical Journal, 2 November 2021? Provide evidence to confirm compliance in relation to all data submitted for approving the Pfizer BioNtech Covid-19 vaccine for use in UK.

All centres participating in a clinical trial need to show that they are complying with Good Clinical Practice (GCP). The MHRA inspectorate conducted a remote inspection of the Biontech-Pfizer vaccine clinical trial in order to verify compliance with internationally recognised Good Clinical Practice requirements (ICH E6). This included information exchange with our international regulator partners to support inspection planning. The sites mentioned in the article were not part of the UK GCP inspection.  The same inspectorate review of safety and data integrity was applied as for any other product to ensure the highest standards of patient safety. On the basis of extensive data we know that the Pfizer/BioNTech COVID-19 vaccine is safe and effective. People should continue to get vaccinated to protect themselves and others. We take allegations of any regulatory misconduct seriously. Our inspections have now concluded and found that there was no impact on the data reliability.

  1. Is the Pfizer-Biotech Covid-19 Booster shot, exactly the same vaccine formulation as used in the earlier two  vaccine doses, or is it an entirely different new vaccine formulation. If so, have clinical trials been carried out on the new booster formulation? If not, please explain why not.

The Pfizer/BioNTech third-dose booster vaccine is the same formulation as the Pfizer/BioNTech vaccine that was administered for the first two doses. The use of the vaccine as a third-dose booster was evaluated through the COV-Boost trial, further information on this trial is provided below.

COV-Boost

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

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

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

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