Freedom of Information request on the regulatory approval of the COVID-19 vaccinations (FOI 22/412)
Published 31 May 2022
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FOI 22/412
14th February 2022
Dear
Thank you for your email.
The Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) granted emergency use authorisation (EUA) to the Covid-19 vaccine BNT162b2 supplied by Pfizer and BioNTech under Regulation 174 of the Human Medicine Regulations 2012 on 2 December 2020. This followed the previous authorisations for Covid-19 vaccines by China and Russia for their own vaccines. The recent announcements have created great hope for a path out of this global pandemic. This brief article seeks to demystify the concept of EUAs and highlight some important considerations as we can expect more submissions for Covid-19 vaccine authorisations in the near future. Our key take-away is that although emergency use authorisations are temporary and subject to ongoing data reviews, regulatory agencies follow rigorous evidence-based approaches to ensure the safety of vaccines authorised using this pathway.
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.
The authorisation announced in the United Kingdom under Regulation 174 is temporary and only relates to a limited number of specific batches of the Covid-19 vaccine BNT162b2 supplied by Pfizer and BioNTech, in response to the increased spread of Covid-19 and deaths in the UK. The conditions of the EUA stipulate that the sponsor “must operate a comprehensive pharmacovigilance (safety monitoring) system for this product in accordance with UK legislation for licensed products, as if they were market authorisation holders.4” This clause ensures that processes are in place to monitor changes in the benefit-risk profile of the vaccine, and facilitate timely revisions to its use, if required.
EUAs are a powerful tool in the public health response arsenal for countries during this pandemic. However, it is important to understand that unlike full market authorisation, they do not make Covid-19 vaccines generally available to the whole population in the same way as influenza vaccines. Rather, they allow governments to deploy available new vaccines as quickly as possible to specific groups of the most vulnerable people such as frontline healthcare workers, older people and other high-risk groups while collecting important data on the novel vaccines to make decisions about broader immunisation programmes.
Please note that a marketing authorisation was granted for the Pfizer/BioNTech vaccine (Comirnaty) following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002).
Please also note that a marketing authorisation was granted for the Moderna vaccine on 31 March 2021 following an EC Reliance Procedure (PLGB 53720/0002).
A marketing authorisation has been granted for the Janssen Covid-19 vaccine on 28 May 2021 (PLGB 00242/0742).
A marketing authorisation was granted for the Oxford/AstraZeneca vaccine on 24 June 2021 following an EC Reliance Procedure (PLGB 17901/0355)
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Yours sincerely
MHRA Customer Experience Centre