FOI release

Freedom of Information request on COVID-19 vaccination and the Yellow Card reporting scheme (FOI 21/892)

Published 20 January 2022

27th August 2021

FOI 21/892

Dear

Thank you for your email dated 4th August, where you asked for information on the following:

1. When did the MHRA first become aware of these potential serious risks compared to the risks of the disease (covid-19), given that these are now being realised and registered in the yellow card system?

2. What is the estimated percentage of the vaccine adverse reactions actually reported in the yellow card system?

With regards to your first question 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 Vaccine Analysis Prints.

We work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects. In addition to this, the nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness. A full list of known risks and side effects can be found in the vaccine Patient Information Leaflet, and can be accessed from the Coronavirus Yellow Card reporting site https://coronavirus-yellowcard.mhra.gov.uk/

Regarding your second question, the reporting rate for spontaneous Adverse Drug Reactions (ADR) is variable and can depend on a multitude of factors. The actual rate is unknown and variable because it is influenced by public awareness and seriousness of the event. In terms of the COVID-19 vaccines, for which there is high public awareness of the Yellow Card scheme this will impact the number of reports received. Additionally, we take into account of the variable levels of reporting as part of our monitoring procedures.

The Medicines and Healthcare products Regulatory Agency (MHRA) has in place a Yellow Card Strategy to promote the scheme and raise awareness amongst healthcare professionals and patients alike. All spontaneous ADR reporting systems worldwide, like the Yellow Card scheme, are known to be subject to under-reporting. Under-reporting of ADRs is thought to occur less frequently with serious reactions and those which are not yet included in the product information. We use statistical analyses which are purposefully designed to minimise the impact of under-reporting by comparing between drugs or vaccines on the Yellow Card database and can take into account of a range of possible levels of reporting.

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