Freedom of Information request about adverse drug reactions (ADR) to Covid-19 vaccines (FOI-21-455)
Published 28 June 2021
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Thank you of your email dated 20 April 2021, where you requested a further breakdown of Table 3 (Number of suspected ADR reports received in the UK) provided within the ‘Coronavirus vaccine – weekly summary of Yellow Card reporting’ publication. Specifically, you requested the total number of events and deaths per country.
The MHRA has been proactively monitoring the safety of all approved COVID-19 vaccines for near real-time safety monitoring at the population level. A summary of Yellow Card reporting concerning the COVID-19 vaccines is published each week and can be found here. The summary includes data analysis on reported suspected adverse reactions from the COVID-19 vaccines, including those with a fatal outcome and the total number of events can also be found within the analysis prints.
With regards to your request for a breakdown per country, this information is due to published in the near future. As such, we have determined that this information is exempt under Section 22 of the of the Freedom of Information Act. Section 22 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from publishing the total number of events and deaths per country. However, we consider that the public interest will be better served by releasing the information when it is in its complete form, rather than the Agency releasing an incomplete version of the data prematurely.
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.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division