Freedom of Information request on the yellow card reports following the COVID-19 vaccine (FOI 21/1322)
Published 31 May 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-27-december-2021/freedom-of-information-request-on-the-yellow-card-reports-following-the-covid-19-vaccine-foi-211322
FOI 21/1322
31st December 2021
Dear
Thank you for your FOI request dated 13th December 2021.
The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card scheme. The MHRA, together with independent expert advice from the Commission on Human Medicines (CHM), is responsible for ensuring that the overall balance of benefits in terms of effectiveness, and risks of medicines and vaccines is positive at the time of licensing and remains so thereafter. Further information about the MHRA’s pharmacovigilance strategy can be found here: 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
Whilst an acceptable level of information has been received to provide assurance that appropriate standards of quality, safety and efficacy have been met for authorisation of the COVID-19 vaccines, patients included in the clinical trials for COVID-19 vaccines continue to be followed up for at least a year to gather further safety and efficacy data and MHRA will continue to receive data from the companies as it becomes available.
There is no evidence so far based on our analysis of reports and trends of ADR reporting to suggest any serious long term side effects to the COVID-19 vaccines.
Regarding your remaining questions, this information is not held by the MHRA.
Kind regards,
FOI Team