FOI release

Freedom of Information request on the safety of COVID-19 vaccines (FOI 21-222)

Published 28 May 2021

6th April 2021 FOI 21/222

Thank you for your email. Please find below answers to the questions you have raised in blue below. For questions 1 and 2 we suggest you contact Public Health England Email: enquiries@phe.gov.uk Telephone number: 020 7654 8000

For questions 3, 4, 5, and 6 please refer to our published data. https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/975888/Coronavirus_vaccine_-summary_of_Yellow_Card_reporting_21.03.21.pdf For question 4, you can identify the most common adverse reactions by looking at ADR terms with the most reports.

1. Under section 4.8 Summary of safety profile of Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine there is the following information: ‘In Study 2, a total of 21,720 participants 16 years of age or older received at least one dose of COVID19 mRNA Vaccine BNT162b and 21,728 participants 16 years of age or older received placebo. Out of these, at the time of the analysis, 19,067 (9531 COVID-19 mRNA Vaccine BNT162b2 and 9536 placebo) were evaluated for safety 2 months after the second dose of COVID-19 mRNA Vaccine BNT162b2.’

Please explain why if the study initially included 43 448 participants (21720 vaccinated +21728 placebo) only 19067 (9531 vaccinated and 9536 placebo) were evaluated for safety 2 months after the second dose. What happened to more than 56% of cohort and why they have not been followed up for safety? Has the manufacturer been questioned about that? The numbers reflect the rolling review nature of the assessment. As stated in the PAR (page 40), “AE data are also provided for the safety population of 37,586 participants with a median of 2 months follow-up after Dose 2, and 19,067 participants with at least 2 months follow-up after Dose 2.” The participants continue to be followed up in line with the study protocol.

1. Is there any indication/research to confirm that the vaccine provides protection for longer than 2 months after the second jab – i.e. has the manufacturer provided further data or perhaps there is an independent research regarding that? If so, for how long (please provide references)? Duration of protection from the vaccine remains unknown. This continues to be investigated.

2. If the vaccines are safe why have the manufacturers been given indemnity by the government and protected from lawsuits?

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.

Regarding indemnity, MHRA holds no data on this. For information on indemnity/liability we advise you contact the Department of Health and Social Care (DHSC) with this request: Web contact form - https://contactus.dh.gov.uk/?openform Please also provide copies of your responses to the following FOIs:
FOI 20/225, FOI 20/226, FOI 20/231, FOI 20/234, FOI 20/239 This is being treated separately under the disclosure request and you will receive a response shortly.

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 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