FOI release

Freedom of Information request on Pfizer/BioNTech COVID-19 vaccine (FOI-20-551)

Published 24 March 2021

Thank you for your email of 8 December 2020, where you have asked “I would like you to kindly provide the following information regarding the Pfizer BioNTech Covid-19 vaccine you have recently described as safe for use and approved for distribution:

A complete list of the ingredients contained in the vaccine

Details of where your studies are published so one may view the outcome data that was prior to the vaccine approval for use by the MHRA

What was the health status and demographics of the study population? Was this group representative of the population this vaccine is intended for? What were the results? Are they significant? What are the limitations of the study and how does this subtract from the relevance of the outcome? Please will you answer those questions individually if this information is not available in the directly above question requesting information release?

Has there been independent reviews of this work prior to vaccine approval for use?

Was the PCR test used to determine a Covid-19 infection?

Is there a list of any safety concerns or contra indications for those who take this vaccine?

What, if any, are its interactions with other medicinal products?

If side effects cannot yet be established prior to use, how will informed consent of the vaccine recipient be established by the administrator of the injection?

If no longitudinal studies are available and this is experimental as a treatment, why is it not classified as a clinical trial as opposed to being called a vaccine?

Who will hold accountability and who has compensatory responsibility for any morbidity and mortality as a result of receiving this vaccine?

What is its efficacy against disease? Will it prevent a Covid-19 infection? Will it reduce severity of infection? Will it prevent symptoms in an infected individual? Does it prevent transmission of the disease?

Does the vaccine contain the Syncytin-1 protein and if so, when an immunological response to this protein is triggered by the vaccine will this cause male and/or female infertility?”

The information that is being requested is in the following documents:

information on the studies conducted using the Pfizer/BioNTech COVID-19 vaccine and their 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 MHRA has also published a Public Assessment Report (PAR) for this vaccine. The PAR contains the non-confidential aspects of The MHRA’s assessment of this vaccine. A link to the PAR is provided below: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

Additionally the information for practitioners lists the undesirable effects experienced by recipients of the vaccine and the full composition of the vaccine: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940565/Information_for_Healthcare_Professionals_on_Pfizer_BioNTech_COVID-19_vaccine.pdf

The MHRA holds no information concerning “who will hold accountability and who has compensatory responsibility for any morbidity and mortality as a result of receiving this vaccine.” We recommend that you contact the Department of Health and Social Care directly for this information Web contact form - https://contactus.dh.gov.uk/?openform

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

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000