FOI release

Freedom of Information request about COVID-19 Vaccine Information (FOI-21-010)

Published 24 March 2021

Thank you for your email.

There is a lot of information published about the vaccines that have been authorised to date. This includes Information for Healthcare Practitioners, Information for Recipients of the Vaccine and Public Assessment Reports (PARs), which can be accessed for each vaccine via the links 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

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

The PARs consist of the non-confidential parts of the MHRA’s assessment of the data submitted for each vaccine, including the efficacy/safety data upon which the Information for Healthcare Practitioners and Information for Recipients of the Vaccine is based, and demographic data concerning the recipients of the vaccines in the trials (including any illnesses and concomitant medication).

In addition, the study results from the Pfizer/BioNTech vaccine are available in a peer-reviewed journal, the New England Journal of Medicine. This includes the efficacy/safety data collected during the clinical trial and demographic data concerning the recipients of the vaccines in the trials (including any illnesses and concomitant medication). A link to this is provided below:

https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home

Regarding your specific questions:

For elderly patients:

The Pfizer/BioNTech vaccine, studies included recipients of the vaccine who are elderly (65 years of age and over), please see page 30 of the PAR (available via the link above.

The Oxford/AstraZeneca vaccine, recipients included 1398 patients who were between 56 and 69 years of age and 821 patients who were 70 years of age or older, please see page 36 of the PAR available via the link above.

The Moderna vaccine, recipients of the vaccine were in two cohorts, one 18 to 64 years of age and another 65 years and over, please see Section 5.1 (Pharmacodynamic properties) in the Information for Healthcare Practitioners available via the link above.

With regards to other patient groups, the NEJM article includes demographic data of the recipients of the Pfizer/BioNTech vaccine, including illnesses and any concomitant medication they were receiving. With regards to the Pfizer/BioNTech and Oxford/AstraZeneca vaccines, the respective PARs provide details of the recipients who received each vaccine, including illnesses and any concomitant medications they were receiving. Based on these data, suitable precautions were added to the Information for Healthcare Practitioners for patient groups, where applicable. There are no precautions with regards to concomitant medication.

With regards to steps taken for elderly patients and vulnerable groups receiving the vaccine, as stated above, any precautions identified for any particular group are stated in the Information for Healthcare Practitioners. In the UK, patients are offered or recommended to have the vaccine, but nobody is forced to receive it. Even in care homes, for example, patient consent is required.

Unfortunately, MHRA cannot comment on your own personal circumstances. We recommend that you discuss whether receiving the vaccine is the correct decision for you personally with your GP or prescribing physician at the time you are contacted by the NHS to inform you that you are eligible for the vaccine. Further advice from the NHS is provided in the link below. This advice states that “the NHS will let you know when it’s your turn to have the vaccine. It’s important not to contact the NHS for a vaccination before then.”

https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/

MHRA has published Information for Recipients of the Vaccine for all three authorised vaccines. These are available through the relevant links above. As stated above, MHRA holds no information on how individual prescribing physicians will discuss with recipients of the vaccine the benefit/risk of receiving the vaccine.

Regarding your question concerning liability, MHRA holds no information on this. We suggest that you contact the Department of Health and Social Care (DHSC) for further information. Their contact details are provided below:

MHRA continuously monitors all suspected side effects reported by patients and healthcare professionals. The MHRA has also put in place an additional proactive safety monitoring plan for all COVID-19 vaccines to enable rapid analysis of safety information. Any new safety signals identified will be reviewed and, if necessary, appropriate regulatory action will be taken.

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] .

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

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