Freedom of Information request about potential safety signals with COVID-19 vaccines (FOI-21-413)
Published 28 June 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-10-may-2021/freedom-of-information-request-about-potential-safety-signals-with-covid-19-vaccines-foi-21-413
Thank you for contacting the MHRA regarding potential safety signals with COVID-19 vaccines.
Under the Freedom of Information (FOI) act, you have requested to be provided with the following:
a) Potential safety signals identified with any COVID-19 vaccine
b) Whether and how to publicly communicate about these potential safety signals
c) Whether and how to publicly communicate about any communication or collaboration on these potential safety signals that has taken place with the European Medicines Agency (EMA), including, but not limited to, with the EMA’s Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC), or members thereof, and with national medicines regulators and vaccination/immunization advisory bodies in EU/EEA countries.
The MHRA publishes a weekly summary of Yellow Card reporting which can be found on this link: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting. In this publication, you will find the specific information you have requested under Section 3, Analysis of Data.
The MHRA work closely with our public health and international partners, including the EMA, in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects. Information on our analysis of Yellow Cards is communicated publicly via our weekly summary of Yellow Card reporting, referenced above.
Communications may also be issued, as necessary, via a number of additional routes, including updates to product information, press releases and briefings, direct healthcare professional communications and our Drug Safety Update.
I hope the information provided is helpful, but 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.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU