FOI release

Freedom of Information request (FOI 22/972)

Published 17 January 2024

FOI 22/972

17th October 2022

Dear

Thank you for your Freedom of Information (FOI) request dated 17 September 2022 where you requested details on a report regarding COVID-19 vaccine Pfizer BioNTech.

The report referred to in your request is a UK, spontaneous, report submitted directly to the MHRA and was entered onto the database as reported. Following a request for further information, the age of the patient was confirmed as incorrect and was subsequently updated on our database. I can therefore confirm that this report involves an adult patient and not a child.

Questions 2-5 of your request relate to the patient, incorrectly reported as a 2 year old and therefore we have not answered this part of your request given that we have confirmed the patient was adult. However, please note, we are unable to provide further information on individual reports as this is exempt from disclosure under Section 40 (personal information) and Section 41 (information provided in confidence) of the Freedom of Information Act. Providing you with the specific details within the report could lead to patient identification. Members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA through the Yellow Card scheme. As outlined in our Privacy Policy, the MHRA will not share the identity of anyone submitting a Yellow Card report with any person outside the MHRA without their explicit consent, unless we are required or permitted to do so by law. The Policy also states that we may receive requests for Yellow Card report data under the Freedom of Information Act. While we are legally obliged to provide some of the requested information, we only provide high-level summary information with all person-identifiable data excluded. The MHRA has been working proactively to encourage members of the public or health professionals across the UK to immediately alert us to any concerns they have without a formal diagnosis using the Yellow Card scheme. The information and data provided to us by these third parties are shared in confidence and, as above, are personal data. Sharing the information and data received with yourself would not reflect the commitments in MHRA’s confidentiality agreements, potential safety signals which would be of detriment both to the application of the Agency’s regulatory function and public health more widely. As this is personal data in relation to an individuals’ health, this would be of detriment to them and may damage the engagement with the scheme.

In your request you ask whether the MHRA has a follow-up system in place and how reporters can be contacted (questions 6 and 8). Reports are routinely reviewed by our assessors for missing information to aid our assessment of potential safety concerns and follow-up requests are sent to the original reporter if necessary and where permission has been given. We follow-up all fatalities for further information, including post-mortem details if available. Reporters provide either a postal or email address or telephone number in order for the MRHA to contact them for further information in the future. They also have the ability to inform us of their healthcare professional details if they wish so that we can follow-up reports directly with them.

Further to part 7 of your request, the MHRA publish a monthly COVID-19 ADR summary alongside analysis prints for each vaccine, these can be found on the Coronavirus vaccines adverse reactions page. This includes details on the number of reports, the types of adverse reactions reported and the safety concerns that have been investigated.

Additionally, the MHRA has a responsibility to inform licence holders of medicines and vaccines of any reports received. The licence holders have a responsibility to inform regulatory authorities, such as the MHRA or US FDA, in the country where their product is being used, of any reports that occur within that territory and of any serious reports that occur worldwide. Therefore, whilst the MHRA do not send reports directly to the US FDA, the licencing authorities have the responsibility to send serious UK reports that it receives from the MHRA to the US FDA. Regarding this particular report, the MHRA are investigating why the incorrect version is still currently available on the FDA VAERs system and are in contact with the licencing holder for this vaccine for further information.

I hope this information is useful and would like to thank you for your support of the scheme. Please do not hesitate to contact me if I can be of any further assistance or you would like further data in subsequent quarters.

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 of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division