Regulatory authorities have been more visible than ever as the approvals of COVID-19 vaccines from different pharma companies have made mass vaccinations a reality in many countries.
In the danish news publication Dagens Medicin, NDAs Advisory Board Director, Dr Steffen Thirstrup shares his opinion about the accelerated approvals conducted by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Summary in English: On the 21st of December, EMA approved a COVID-19 vaccine candidate after a rolling review process. The pathway is used in an emergency context to allow EMA to continuously assess the data for an upcoming and promising application as they become available. Once the data package is sufficiently complete it can proceed to formal marketing authorisation application (MAA) which, after validation, will be processed under a shortened timetable. This way, the process of approval of the vaccine took 70 days compared with 210 days under normal circumstances.
In the US, FDA issued the first emergency use authorization (EUA) for another vaccine candidate on the 12th of December to facilitate the availability and use during the current public health emergency. This has opened up for discussions whether the European procedure is not sufficient or fast enough during a global crisis such as the COVID-19 pandemic.
Steffen Thirstrup has a firm stance amid these discussions; “Ten days makes no difference in this case”, he says and explains further: “When the purpose is to vaccinate a whole population, it all comes down to the logistics”.
The FDA and EMA have different instruments for accelerated approvals of new drugs or indications of drugs and these pathways have different requirements during the review process and market introduction. Several factors were involved in the swift EUA issued by the FDA. The sponsor applied earlier in the process and the FDA review process always forms a close relationship with the sponsor with several pre set milestones making the route take less time.
This closeness is an advantage, but according to Steffen Thirstrup, the rolling review is the preferred process in comparison. “The data is reviewed in real time, the data becomes publicly available and the product acquires approval, although conditioned”, he says. “The same amount of transparency is not available when issuing an EUA. Transparency is important when it comes to earn the trust of the population and the European approval has full transparency”.