FOI release

Freedom of Information request on long term muscular effects and stomach issues following vaccination against COVID-19 (FOI 22/791)

Published 4 January 2024

FOI 22/791

27th July 2022

Dear

Thank you for your further email and information request, dated 26 June 2022 where you asked

1. Is there a national centre which I could be referred to (or my GP could consult) for clinical advice?

2. Could you give me any help as you suggest regarding follow up of cases that require more detail to aid assessment as outlined in previous MHRA correspondence?

3. Have long term muscular effects and stomach issues been detected as a ‘signal’?

4. Please could you send me a report for the AZ vaccine explaining which signals you have examined and conclusions?

We are unable to provide a response to your first question which relates to your individual case. Further, in relation to your second question about MHRA follow up, we would like to clarify that MHRA follow up of individual Yellow Card reports of suspected adverse drug reactions is carried out to aid our signal assessments of potential safety issues and is not used to provide individual clinical case assessment and advice. As you will be aware from our previous response, MHRA does not provide specialist advice to patients and medical advice is not within our remit of work. We would again encourage you to discuss any concerns you may have with your doctor who will be in the best position to advise you.

With regard your third question on long term muscular effects and stomach issues following vaccination against COVID-19, one of MHRA’s main roles is to continually monitor safety during widespread use of a vaccine and we have in place a proactive strategy to do this (available at: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance). We also work closely with our public health partners in reviewing the effectiveness and impact that the vaccines are having to ensure benefits continue to outweigh any possible side effects. In addition, we work with our international counterparts to gather information on the safety of vaccines in other countries. To date, long term muscular effects and stomach issues have not been detected as a signal in association with AstraZeneca COVID-19 vaccine.

We are responding to your fourth question asking for ‘a report for the AZ vaccine explaining which signals you have examined and conclusions’ under the FOI act.

Although we hold information on all signal reviews for the AstraZeneca COVID-19 vaccine, we have been continually monitoring Yellow Card reports and performing signal detection and assessment all the COVID-19 vaccines, including the AstraZeneca COVID-19 vaccine since it was first authorised in December 2020, and therefore the request for information within your correspondence would fall under Section 12 of the FOI Act. Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with the request would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving, and extracting the information. We consider that extracting all the signal reviews for the AstraZeneca COVID-19 vaccine will take longer than 24 working hours to complete.

Please be advised, however, that MHRA publishes a regular summary of Yellow Card reporting for COVID-19 vaccines (available at: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting. This report has provided timely and relevant information to patients and healthcare professionals on the safety of the COVID-19 vaccines as they were deployed in the UK throughout the pandemic including reports received in association with the AstraZeneca COVID-19 vaccine. The report includes information on the overall safety of COVID-19 vaccines and their safety in specific populations, as well as comments on specific safety topics.

Please be assured that the MHRA keeps the safety and effectiveness of the COVID-19 vaccines under close and continual review.

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

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

FOI Team,

Safety and Surveillance

Medicines and Healthcare products Regulatory Agency