FOI release

Freedom of Information request on the authorisation of emergency-use medicines (FOI 22/602)

Published 14 June 2022

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-11-april-2022/freedom-of-information-request-on-the-authorisation-of-emergency-use-medicines-foi-22602

FOI 22/602

11th April 2022

Dear

Thank you for your email of 25th March where you have asked about “Risk Management. Did MHRA request to see raw data for mRNA vaccine trials prior to approval?”

  1. What specific criteria are used by the MHRA to determine the appropriate circumstances for an Emergency Use Authorisation in respect of non-licensed/experimental drugs? i.e. What specific conditions constitute an “emergency” situation which warrants the authorisation of unlicensed medicines/drugs/vaccines?

  2. What is the MHRA’s accepted structure for a comprehensive risk assessment in respect of unlicensed medicines? i.e. What questions should the risk assessment address?

  3. Did anyone working within the MHRA actually request to see ANY raw data (i.e. data that is collected from a source, but in its initial unprocessed state) associated with any and/or all Covid-19 mRNA vaccine trials PRIOR to MHRA approval under EUA?

  4. If the answer to question 3 is “yes”, what was the response to the request (or what were the responses) from the vaccine manufacturers?

Please see the information requested below.

1) What specific criteria are used by the MHRA to determine the appropriate circumstances for an Emergency Use Authorisation in respect of non-licensed/experimental drugs? i.e. What specific conditions constitute an “emergency” situation which warrants the authorisation of unlicensed medicines/drugs/vaccines?

An Emergency Use Authorisation (EUA) is a regulatory mechanism to facilitate the availability and use of medical countermeasures, including unapproved or investigational health products, during public health emergencies, such as the current Covid-19 pandemic. National Regulatory Authorities (NRAs) can issue an EUA when certain legal criteria have been met such as a national health emergency and/or no adequate, approved, and available alternatives. It is not just NRAs that can use emergency use mechanisms. After the experience during the West African Ebola outbreak from 2013-2016, the World Health Organisation (WHO) developed the Emergency Use Assessment and Listing (EUAL) procedure for health products which was updated in January 2020 with the Emergency Use Listing (EUL) procedure3.

The specific conditions of emergency use mechanisms may differ among jurisdictions and in some jurisdictions similar regulatory mechanisms may have different names. A common element of most emergency use procedures is an assessment of whether submitted (and frequently limited) data demonstrate a reasonable likelihood that a product’s quality, safety, and efficacy are acceptable, and that the benefits outweigh potential risks and uncertainties in the context of a public health emergency of national or international concerns.

2) What is the MHRA’s accepted structure for a comprehensive risk assessment in respect of unlicensed medicines? i.e. What questions should the risk assessment address?

As we have stated above in Q1 “an assessment of whether submitted (and frequently limited) data demonstrate a reasonable likelihood that a product’s quality, safety, and efficacy are acceptable, and that the benefits outweigh potential risks and uncertainties in the context of a public health emergency of national or international concerns.”

3) Did anyone working within the MHRA actually request to see ANY raw data (i.e. data that is collected from a source, but in its initial unprocessed state) associated with any and/or all Covid-19 mRNA vaccine trials PRIOR to MHRA approval under EUA?

It is a requirement for any company seeking authorisation of their medicinal product by MHRA to provide all data from clinical studies conducted.

4) If the answer to question 3 is “yes”, what was the response to the request (or what were the responses) from the vaccine manufacturers?

Please see above, all data from clinical studies conducted must be submitted to MHRA in order for MHRA to assess and authorise that medicinal product for use. MHRA does not request the data, as it is a mandatory requirement.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Yours sincerely

MHRA Customer Experience Centre

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