The recent news concerning three potential candidates for vaccines that can help stop the spread of Covid-19 during the global pandemic has increased and in some circles intensified the discussions revolving around emergency approvals for pharmaceutical distribution.
BioNTech and Pfizer, who jointly worked on a Covid-19 vaccine candidate, have announced they have requested emergency authorisation from the US Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
This would enable the vaccine to be sold directly by the manufacturer to health authorities without going through the standard drug approval process, which can sometimes take an exceptionally long time.
How this works, depends on the authority, but here are the approval processes of the three main authorities mentioned above.
Exceptional Use Authorisations In UK
The MHRA have a strict requirement for all medications to have a CE marking, which shows they have gone through a rigorous approval process.
However, if there is no legitimate alternative available, the MHRA have an exceptional use approval process, which requires the approval of the Secretary of State and has been extended in scope since the beginning of the pandemic.
The process is undertaken on a case-by-case basis and is currently based heavily on the EMA’s approval process.
EMA Emergency Procedure
Typically, a vaccine for an influenza disease such as SARS would require evidence and studies, which typically takes between 18 and 24 months, however, the European Union have an emergency fast track approach to approving vaccines.
Typically, the pandemic approval procedure intends to approve mock-up vaccines that can protect against a range of strains and are prepared in advance of a pandemic, where the test strain is replaced with the pandemic strain of the virus.
In this case, however, the vaccine is being produced during the pandemic, and therefore needs to show the effects of the vaccine on volunteers and any side effects, typically in a rolling review process that allows authorities to evaluate in real-time.
Once there is enough data to show its effectiveness outweighs potential side effects and risks, a formal application is made to the EMA, which takes around 70 days to make a decision.
This decision then moves to the European Commission, where it can take up to 45 days to make a decision.
After this, the vaccine is given conditional approval, which usually means more information will need to be provided after it has been rolled out.
FDA Emergency Use Authorisations
The US FDA have a provision under section 564 of the Federal Drug and Cosmetic Act where the Commissioner of the FDA can allow for medical products which are not approved yet or unapproved used of approved medical products to be used in an emergency if there is no alternative.
These exceptions are subject to continues review of evidence and trials, which can in some cases lead to a medication being deauthorised for emergency use if it turns out it is not effective or has serious side effects.
This happened in the case of hydroxychloroquine sulfate and chloroquine phosphate; these two drugs were added to the emergency use authorisation list and then revoked once the side effects and lack of efficacy were demonstrated.