FOI release

Freedom of Information request on the total number of consultations by MHRA with the Commission on Human Medicines (CHM) and its Expert Groups in relation to Covid vaccine adverse effects (FOI 21/1252)

Published 31 May 2022

FOI 21/1252

15th December 2021

Dear,

Thank you for your FOI request dated 19th November 2021, where you asked:

“I refer to your link where it says “The MHRA will consult the Commission on Human Medicines (CHM) and its Expert Groups and, if deemed necessary, regulatory action would be taken to minimise risk and support safe use of a given vaccine (e.g. adding warnings to the product information, sending out communications to healthcare professionals and patients, restricting its use). “

With reference to the above, please supply me with the total number of consultations by MHRA with the Commission on Human Medicines (CHM) and its Expert Groups in relation to Covid vaccine adverse effects.”

The COVID-19 Vaccines Benefit Risk Expert Working Group (VBR EWG) has held 68 meetings since it was formed in August 2020, several topics are discussed at each meeting including discussions on different potential side effects.

We intend to publish the minutes of the consultations with the Commission on Human Medicines (CHM). As we plan to publish the data, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure.

Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it.

I hope this information is useful, 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