FOI release

Freedom of Information request the reason MHRA has decided to publish COVID-19 vaccine reactions in iDAP format when it does not publish Vaccine Reactions in iDAP format (FOI 21/1170)

Published 26 May 2022

FOI 21/1170

24th November 2021

Dear,

Thank you for your email dated 27 October in which you requested information on the following:

• What is the reason MHRA has decided to publish COVID-19 vaccine reactions in iDAP format when it does not publish Vaccine Reactions in iDAP format?

• Can you additionally provide the first publicly published intention of MHRA to provide COVID-19 vaccine iDAP?

The MHRA have two formats for Drug Analysis Prints (DAPs); one which is interactive and is available on our website and the other which is not interactive. The format which is not interactive is currently being used for the COVID-19 Vaccine Analysis Prints published within our weekly summary of Yellow Card reporting.

We are reviewing how we can make vaccine data across all products more widely available. Regarding COVID-19 vaccines specifically, as stated in our previous correspondence, the MHRA intends to publish all suspected reactions reported in association with available COVID-19 vaccines in an interactive format, along with our ADR summary that is published each week. This is because we recognise there is strong interest in seeing this data and accept it should not be withheld. As you will know from our previous correspondence, the MHRA is awaiting approval to publish iDAPs for the COVID-19 vaccines and will provide a link to these when they become available.

Regarding the first publicly published intention of MHRA to provide COVID-19 vaccine iDAP, please refer to the information already published under Freedom of Information responses from the MHRA: 2021.

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