FOI release

Freedom of Information request on the use and temporary authorisation of repurposed medication to treat COVID-19 (FOI 21-417)

Published 28 June 2021

6th May 2021 FOI 21/417

Dear

Thank you for your email.

Please find below answers to the questions you raise below;

1. Which government department/s are responsible for deciding which repurposed medication can be used for Covid 19?

MHRA authorises medicines for use in specific indications, including the repurposing of current authorised medicines for use in treating Covid-19 infection.

1. Who is the individual ultimately responsible for the decision in 1. Above?

The MHRA is advised by the Commission on Human Medicines (CHM), an independent public body that advises ministers on the safety efficacy and quality of medicinal products. The membership of the CHM is published: https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership

The Chair and Commissioners are appointed in accordance with the Code of Practice for Ministerial Appointments to Public Bodies, issued by the Commissioner for Public Appointments. The Chair and Commissioners follow a code of practice, in which they are precluded from holding personal interests. Their interests in the pharmaceutical industry are published in the Commission’s annual report each year.

The CHM is advised by a COVID-19 Vaccines Benefit Risk Expert Working Group and the membership of this Group is also published in the link provided above.

1. Which government department/s are responsible for granting ‘temporary authorisation’ for a medication for Covid 19?

MHRA is responsible for authorising medicines, including the vaccines that have been authorised for use in preventing Covid-19 infection.

1. Is the granting of ‘temporary authorisation’ conducted by the same department/s as the decision to repurpose a medication.

Yes the authorisation of the vaccines is conducted by MHRA, although some decisions to authorise medicines are done following a European Commission decision.

1. What process is used to make the decision to repurpose a medication for Covid 19 and to grant ‘temporary authorisation’?

The process for repurposing a medicine is described above.

The temporary authorisation of the vaccines was done through an expedited rolling review. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis. The temporary authorisation under Regulation 174 permits the supply of identified vaccine batches, based on the safety, quality and efficacy data submitted to MHRA. These authorisations do not constitute a marketing authorisation.

All vaccines are tested through three phases of clinical trials to ensure they meet the gold standard. Phase 1 trials are with a small group of people to make sure there are no safety concerns and determines the appropriate dosage for the best immune response. Phase 2 trials are conducted on a larger group of people to check the vaccine works consistently and that the immune response is sufficient. Phase 3 trials test the vaccines on thousands of people for scientists to assess if the vaccine is producing immunity that will prevent disease. Usually, these phases are run in sequence, but in an effort to find a safe and effective Covid-19 vaccine as quickly as possible, once safety has been ascertained through Phase 1, Phases 2 and 3 are being run in parallel. Extensive checks and balances are required at every stage of the development of a vaccine, and this is no different for a Covid-19 vaccine. No stages in the vaccine development processes were bypassed.

Please note, the Pfizer/BioNTech vaccine (Comirnaty) was granted a marketing authorisation following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002). Further information is available on the European Medicines Agency (EMA) website, a link to this is provided below: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

The Moderna vaccine was granted a marketing authorisation on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002). Further information is available on the MHRA website and the EMA website, links to these are provided below: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna

In addition, the European Commission, following recommendations from the European Medicines Agency (EMA), have granted a marketing authorisation for the Oxford/AstraZeneca vaccine. Further information is provided below: https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

1. Is the Therapeutics Taskforce involved in the decision as to which repurposed medication to use for Covid 19? If so what is their remit and how does their decision making process interact with other government departments?

We suggest you contact the Department of Health and Social Care (DHSC) for information on the Therapeutics Taskforce, as per the link below.

The COVID-19 Therapeutics Taskforce - GOV.UK (www.gov.uk)

Web contact form - https://contactus.dh.gov.uk/?openform

Please review the following links to MHRA ‘About us’: About us - Medicines and Healthcare products Regulatory Agency - GOV.UK (www.gov.uk) And MHRA guidance on coronavirus MHRA guidance on coronavirus (COVID-19) - GOV.UK (www.gov.uk)

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 email: [email protected]

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.

After that, if you remain dissatisfied, you may write to the Information Commissioner at; The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF. They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU