FOI release

Freedom of Information request on reports of fatality after receiving the COVID-19 vaccine (FOI 21-262)

Published 28 May 2021

8th April 2021 FOI 21/262 Dear

Thank you for your recent submission via the Contact Us form on the Yellow Card website dated 22nd March 2021, regarding underlying illnesses or conditions said to be present in those people who have died shortly after receiving the COVID-19 vaccine.

The general safety profiles of the COVID-19 vaccines authorized in the UK are broadly similar to other types of routinely used vaccines; and our robust regulatory work continues to reinforce that the safety profile of the vaccines remains positive. During clinical trials for all medicines and vaccines, including COVID-19 vaccines, it is unfortunately not possible to include all underlying health conditions when assessing the safety of each vaccine. Therefore, pharmacovigilance is an essential practice which continues to ensure the vaccine is safe, and to monitor for certain side effects in those with underlying conditions. When carrying out pharmacovigilance surveillance as described above, the MHRA considers a patient’s medical history and concurrent conditions when assessing reported side effects, to determine if their conditions may be aggravated by the vaccine. During clinical trials, drugs and vaccines are also tested on a cohort of healthy patients initially, to determine the side-effect profile of this drug or vaccine, prior to its administration to more clinically vulnerable patients. To reiterate, a drug or vaccine is not approved by the MHRA until this regulatory body has performed rigorous assessment of the clinical trial data and is confident of the safety.

As you know, the Medicines and Healthcare products Regulatory Agency (MHRA) runs the Yellow Card Scheme which collates and reviews reports of suspected ADRs to medicines and vaccines, and we can provide data relating to the ADR reports we have received.

Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information. Unfortunately, in this instance your request falls under Section 12 of the FOIA as the information you have requested relating to underlying medical conditions in people who have died shortly after receiving a COVID-19 vaccine is detailed in the case narrative for a report and therefore each report would have to be manually reviewed to identify this information. We consider that retrieving the information that you have requested from Yellow Card reports will take longer than 24 working hours to complete.

Although we are not able to provide the data you have requested, I hope the information about our processes provides reassurance about the vigilance activities that are in place surrounding the COVID-19 vaccines. 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.