Freedom of Information request on the investigations of adverse reaction reports (FOI 22/021)
Published 31 May 2022
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-7-february-2022/freedom-of-information-request-on-the-investigations-of-adverse-reaction-reports-foi-22021
FOI 22/021
7th February 20222
Dear
COVID-19 Adverse Reaction procedures, policies and templates
Thank you for your Freedom of Information request dated 6th January, where you asked for information on the following:
Please provide the following in relation to COVID-19 vaccines:
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Procedures and policies relevant to the investigation of adverse reactions reported to the MHRA.
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Templates used for reporting adverse reaction data and investigations of adverse reactions to stakeholders.
As with any vaccine or medicine, COVID-19 vaccines require continuous safety monitoring to ensure that the benefits in protecting people against COVID-19 outweigh any side effects or potential risks. Further information, specifically relating to the safety monitoring process for COVID-19 vaccines is outlined the COVID-19 Vaccine Surveillance Strategy. Please follow this link to the document: https://www.gov.uk/government/publications/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance
Information on how the MHRA monitors the safety of all medicines and vaccines can be found via the following link. As described in the link, investigation of adverse drug reaction (ADR) reports, known as signal detection, is performed using specialised software. This software analyses all drug-reaction combinations on the MHRA’s database to identify combinations that occur more frequently than would be expected compared to background rates. ‘Signals’ that meet defined criteria are then assessed by a multidisciplinary team of experts to determine the likelihood of a causal relationship between the drug and the reaction, and to determine if regulatory action is appropriate.
With regards to your second question, on how the MHRA communicates with stakeholders, this is also addressed in the second link provided above “How the MHRA monitors the safety of medicines”. As the document describes, where a new harm is identified, or new information about an existing side effect comes to light, the product information will be amended accordingly. Changes may also be communicated via the Drug Safety Update to alert clinicians of the new information: https://www.gov.uk/drug-safety-update .
With regards to communication specifically related to COVID-19 vaccine matters, you may already be aware that we are publishing a weekly summary of Yellow Card reporting which is available here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
I hope the information provided is helpful.
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