FOI release

Freedom of Information request about adverse drug reactions (ADR) to Covid-19 vaccines (FOI 21/196)

Published 7 May 2021

Thank you for your emaildated 19thFebruary2021, where you requested the following informationfor the COVID-19vaccines:

“Q1: For the purposes of informing its continuous monitoring of Covid vaccine safety, what percentage of adverse reactions actually experienced by people being vaccinated does the MHRA assume/estimate is being recorded via the Yellow Card system specifically for Covid vaccinations?

Q2: On what evidence is the MHRA’s assumption/estimate based?

”One of MHRA’s main roles is to continually monitor safety of medicines and vaccines during widespread use, and we have in place a proactive strategy to do this for COVID-19 vaccines. Through this strategy we are able to rapidly detect, confirm, and quantify any new risks and weigh these against the expected benefits. We can then take any necessary action to minimise risks to individual

Many factors can affect reporting levels and the precise level of reporting for COVID-19 vaccines cannot be quantified. We are raising awareness of our dedicated Yellow Card reporting site for medicines and vaccines used in the pandemic and are encouraging everyone to report any suspected side effects to us.

We take into account the variable levels of reporting as part of our monitoring and signal detection procedures, including sensitivity analysis to adjust for different levels of reporting when assessing safety.

Since the start of the vaccine campaigns we have been working in close collaboration across the healthcare system to ensure healthcare professionals and patients areaware of the Yellow Card scheme and how they can report to us.

Information on Yellow Card reporting has been included in NHS training materials, as well as the materials available to individuals both before and after vaccination. Both vaccine recipients and healthcare professionals are strongly encouraged to report any suspicion of a side effect to the MHRA.

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 TeamVigilance and Risk Management of Medicines Division

The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information.

For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Copyright notice The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement fromthe copyright holder.