Freedom of Information request on the authorisation and effectiveness regarding the COVID-19 vaccinations (FOI 22/823)
Published 4 January 2024
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FOI 22/823
26th July 2022
Dear
Thank you for your email.
The trial data submitted for each Covid vaccine has been published by the EMA, a link to this is provided below:
https://clinicaldata.ema.europa.eu/web/cdp/home
The SmPCs, PIL and PARs are published on the MHRA website, see link below:
The SmPCs and PILs contain the details underpinning the authorisation of each vaccine. The PARs contain MHRA’s assessment of each vaccine, including assessment of the benefit/risk.
Details of the MHRA committees are available on the website, including declarations of interest. A link to these are provided below:
https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership
The MHRA works closely with our public health partners in reviewing the effectiveness and impact of COVID-19 vaccines to ensure the benefits continue to outweigh any possible side effects, and the MHRA has a comprehensive safety monitoring strategy for COVID-19 vaccines. This is available online: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance
This monitoring strategy is continuous, proactive and based on a wide range of information sources. A dedicated team of scientists review information daily to look for safety issues or unexpected rare events. Part of the MHRA’s monitoring includes reviewing reports of suspected side effects reported via the Yellow Card Scheme. The MHRA publishes a report summarising information on suspected side effects: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
If you have a query about the information provided, please reply to this email.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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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:
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Yours sincerely
MHRA Customer Experience Centre