FOI release

Freedom of Information request on Yellow Card reporting for COVID-19 (FOI 21/872)

Published 20 January 2022

20th August 2021

FOI 21/872

Dear

Thank you of your email dated 1st August 2021, where you requested the following under the Freedom of Information Act:

1. What percentage of serious reactions to the Covid-19 vaccines from Pfizer, AstraZeneca and Moderna have been reported between December 9th 2019 and the most recent date for which data is known. Please provide an estimate as you have previously been able to with other medicines and vaccines, if figures are unknown.
2. What percentage of fatal reactions to the Covid-19 vaccines from Pfizer, AstraZeneca and Moderna have been reported between December 9th 2019 and the most recent date for which data is known. Please provide an estimate as you have previously been able to with other medicines and vaccines, if figures are unknown.
3. If details about the percentage of adverse reactions to the Covid-19 vaccines being reported are unknown, what is the current estimated percentage of adverse reactions currently reported for all qualifying medicines, vaccines, treatments that should be reported on the Yellow Card system?
4. What communications are being sent to medical professionals to remind them to record any adverse reaction on the Yellow Card site?
5. Why was the website page https://www.gov.uk/drug-safety-update/yellow-card-please-helpto-reverse-the-decline-in-reporting-of-suspected-adverse-drug-reactions taken down and when was it taken down?
6. Where can the UK general public access the details of what percentage of adverse drug reactions the MHRA estimates are reported?

Regarding your first three questions and sixth question surrounding the percentage of serious and fatal reactions reported following COVID-19 vaccination and the current estimated percentage of adverse reactions currently reported for all qualifying medicines, vaccines, treatments to the Yellow Card Scheme, the reporting rate for spontaneous ADRs is variable and can depend on a multitude of factors.

Although some historical studies have estimated only 10% of ADRs are reported, the actual rate is unknown and variable because it is influenced by public awareness and seriousness of the event. These estimates should not be used as indicators of the reporting rate for COVID-19 vaccines, for which there is high public awareness of the Yellow Card scheme and the reporting of suspected reactions. Additionally, we take into account the variable levels of reporting as part of our monitoring procedures. As part of its continual assessment of the safety information of medicines and vaccines, the Medicines and Healthcare products Regulatory Agency (MHRA) makes use of information from a range of sources, including the Yellow Card scheme, clinical trials, and safety studies from use of medicines and vaccines after they have been licensed.

You may be interested to see our weekly summary of Yellow Card reporting for an overview of what has been reported (Coronavirus vaccine - weekly summary of Yellow Card reporting - GOV.UK (www.gov.uk)). Here you can find a summary of all the Yellow Card reports submitted for each of the COVID-19 vaccines as well as analysis on specific reactions and events. The Vaccine Analysis Prints (VAPs) at the bottom of this webpage show the number of Yellow Card reports received for each suspected reaction, as well as how many of them had a fatal outcome.

Regarding your fourth question concerning communications sent to medical professionals, the MHRA has in place a Yellow Card Strategy to promote the scheme and raise awareness amongst healthcare professionals and patients alike. The COVID-19 vaccines have been given to millions of people in the UK and we have worked to ensure that people know to report suspected side effects to the Yellow Card scheme. In addition to social media campaigns, we have issued a Drug Safety Update, a press release, and embedded information about Yellow Card reporting into healthcare professionals training materials to enable us to rapidly identify new and emerging side effects. The general public have also been encouraged to report any suspected side effects to the vaccine to the MHRA via a Yellow Card on the recent televised press briefings and vaccination materials signpost individuals to the Coronavirus Yellow Card reporting site.

In regards to question 5 about the article on reversing the decline in reporting of suspected adverse drug reactions, this page was not taken down and can be found here:

https://www.gov.uk/drug-safety-update/yellow-card-please-help-to-reverse-the-decline-in-reporting-of-suspected-adverse-drug-reactions

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