Freedom of Information request about Covid vaccine safety (FOI-21-007)
Published 24 March 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-1-february-2021/freedom-of-information-request-about-covid-vaccine-safety-foi-21-007
2 February 2021
Thank you for your email dated 4th January 2021 where you requested information about adverse drug reactions (ADR) to Covid-19 vaccines, I can confirm that the MHRA does hold this data.
We will publish details of all suspected reactions reported in association with available COVID-19 vaccines in the near future, along with our assessment of the data on a regular basis. This is to provide transparent and clear information about the ongoing benefit and risk assessment of available vaccines.
As we plan to publish the data in the near future including narrative assessment of the data and any issues identified, your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is exempt from earlier disclosure.
We are pleased there is strong interest in seeing this important data; we consider that this is best met by publishing the finalised data with an analysis to aid its interpretation.
As above, we expect that this will be published in the near future and when it is, we will send you the link to both the data and our assessment.
In regards to the question you raise on “ Could you also confirm how many patients have had a positive PCR test after being vaccinated” you may wish to contact Public Health England (PHE) for advice.
Email: enquiries@phe.gov.uk
Telephone: 020 7654 800
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.
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
5 February 2021
Thank you for your email.
Further to our response of 2nd February we are pleased to confirm we have now published the data and this is available to view at the following link of our website page below.
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 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.
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