FOI release

Freedom of Information request on when the current COVID-19 vaccines will be fully authorised and approved (FOI 22/153)

Published 1 June 2022

FOI 22/153

11th March 2022

Dear

Thank you for your email.

Please find below answers to the questions you have raised.

1 Can you please advise as to when the Current Cov19  vaccines will be fully authorised and approved

2 When the emergency authorisation ends for administering these vaccines

3 What is the criteria to be able to use as  “emergency authorisation “ ie cases/deaths

For questions 1 to 3.

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).

4 Have any of these vaccines been batch tested by independent/government bodies ie MHRA etc (as haven’t been able to ascertain any of these results in the public domain)

All batches of vaccine authorised under Regulation 174 were tested to ensure that they met the authorised specification criteria before they could be used in the UK.

5 Regarding Nuvaxovid it is noted that this has now been authorised however according to your own website dated 3rd Feb2021 the 3 trials have yet to be completed ,2 are still in stage 3 trials and one is in stage 2

How can this be safely authorised when trials have yet to be finalised ?

Study 1 (2019nCoV-301)

Study 1 is an ongoing Phase 3, multicentre, randomised, observer-blinded, placebo-controlled study in participants 18 years of age and older in United States and Mexico.

Study 2 (2019nCoV-302)

Study 2 is an ongoing Phase 3, multicentre, randomised, observer-blinded, placebo-controlled study in participants 18 to 84 years of age in the United Kingdom

Study 3 (2019nCoV-501)

Study 3 is an ongoing Phase 2a/b, multicentre, randomised, observer-blinded, placebo-controlled study in HIV-negative participants

The main efficacy and safety results for the Phase I, II and III trials for all authorised vaccines have been submitted to MHRA, sufficient that these vaccines can be authorised for use in the patient populations stated in the Information for Healthcare Professionals/Summary of Product Characteristics for each vaccine. These studies are currently ongoing to follow-up vaccine recipients to collect additional safety data, in the same way that all clinical trials for new medicines follow up their study subjects after the main results of the study have been reported. Other studies that are currently in progress are to investigate the use of vaccine outside of the current authorisations (such as giving different brands of vaccine for the first and second doses).

6 Where is the full clinical study on this new vaccine

MHRA intends to publish a Public Assessment Report (PAR) in the near future. This PAR represents the non-confidential parts of MHRA’s assessment of this vaccine.

Further, the European Medicines Agency (EMA) have published a PAR for this vaccine, which can be accessed via the below link:

https://www.ema.europa.eu/en/medicines/human/EPAR/nuvaxovid

The clinical data for Nuvaxovid will be published by the EMA in the near future. A link to the clinical data published by the EMA is provided below:

https://clinicaldata.ema.europa.eu/web/cdp/home

If you have a query about this letter, please do not hesitate to contact us at IE&SFOI@mhra.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: info@mhra.gov.uk

Due to the ongoing Covid-19 pandemic, 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 Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000