One early frontrunner applied for emergency use authorisation with the US Food and Drug Administration (FDA) just days after finishing its final round of human clinical trials. If approved, this vaccine would be deemed ‘investigational’ and could be administered as long as research studies are ongoing, with anyone who receives the vaccine getting a fact sheet describing the potential benefits and risks.
In Canada there is no emergency use authorisation process available. Instead, it is using the ‘Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19’, which was signed into order by the minister of health on 16 September 2020. The interim order allows for the expedited authorisation for drugs related to COVID-19. This also allows Health Canada to review and approve medicines and medical products related to COVID-19 on a rolling basis, allowing for immediate review as data becomes available. Approval comes upon the evidence showing benefits outweighing risks.
The European Medicines Agency (EMA) has adopted a similar strategy, allowing for rolling evaluation of evidence and authorisation once the benefits outweigh any known or potential risks. In addition, the EMA stated that at least one well-designed large-scale phase III efficacy clinical trial with the endpoint of laboratory-confirmed COVID-19 disease of any severity in baseline seronegative participants, will be required to support marketing authorisation, in order to show that the vaccine protects against people who have not been previously exposed to COIVD-19. Follow-up on safety and efficacy after marketing authorisation and during vaccination campaigns are also expected.
In the UK, until the end of the Brexit transition period, any EMA-licensed vaccine will automatically be valid. After the transition period, vaccine candidates will need to be assessed directly by the Medicines and Healthcare products Regulatory Agency (MHRA). Although the usual full marketing authorisation process is preferred, a temporary authorisation route (Regulation 174 of the Human Medicines Regulations) can be granted if the government, under the advice of the independent Joint Committee on Vaccination and Immunisation (JCVI), requests the MHRA approves a specific product as part of a public health response. To date, the government has formally requested that one of the vaccine candidates be assessed under Regulation 174 for temporary supply. As expected, key evaluation criteria will include safety, quality and efficacy. The MHRA further details that data must include results from the lab and clinical trials in humans, manufacturing and quality controls, product sampling and testing of the final product.
This a fast-moving topic and MAP will continue to update members with significant changes to the situation, particularly with regards to the regulatory processes, via MAP Online News.
Copyright © 2021. MAP BioPharma Limited. All rights reserved.
MAP BioPharma Limited
Upper Pendrill Court, Ermine Street North
Papworth Everard, Cambridge
Cambridgeshire, CB23 3UY
+44 (0) 1480 832360
MAP BioPharma Limited is a registered company in England and Wales. Company Registration Number 08209281
VAT Group Registration Number GB 292 8576 52