Freedom of Information request on adverse reactions reported following the COVID-19 vaccination (FOI 22/098)
Published 31 May 2022
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FOI 22/098
23rd February 2022
Dear,
Thank you for your emails to the MHRA on 25 October and 29 November 2021. Please accept our apologies for not responding to this correspondence under the Freedom of Information (FOI) act. Your correspondence has now been logged under the reference number FOI 22/098 and a response provided below. On the 25 October you requested the following information under the FOI act:
As of 14 October 2021, of the 1.236 million adverse reactions and 1,715 deaths reported since the vaccines rollout in 2020. How many have the MHRA investigated?
On the 29 November 2021 you also requested the following:
How many of the 1.284 million adverse reactions and 1,789 reported deaths from the COVID-19 vaccines rolled out from December 2020 have the MHRA investigated?
As a result of the COVID-19 pandemic, the MHRA sought advice from the Commission on Human Medicines (CHM) who established an Expert Working Group (EWG), consisting of experts from various fields, to provide the MHRA advice on its COVID-19 vaccine vigilance activities. Based on advice from the EWG, the MHRA developed a four-stranded approach for proactive vigilance of COVID-19 vaccines. These four strands of MHRA’s strategy help rapidly detect, confirm, characterise and quantify any new risks that were not detected in clinical trials, to weigh these against the expected benefits and take any necessary action to minimise risks to individuals. More information on COVID-19 vaccine safety surveillance can be found here.
One of these four strands involves enhanced passive surveillance. The figures quoted in the request above concern numbers of Yellow Card reports submitted to the Yellow Card scheme. The Yellow Card scheme underpins medicines and vaccines safety monitoring in the UK. Through this scheme, members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA.
In response to your question above, a team of MHRA scientists continually review all reports submitted via the Yellow Card scheme and contact reporters to obtain more information, where required. Scientific and clinical assessment is used to determine if an individual or series of reports indicate a new safety concern.
It is important to note that Yellow Card reports are not proof of a side effect occurring due to a vaccine but a suspicion by the reporter that the vaccine may have caused the side effect. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division