Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency
Excellent analytics and perspective contextualising the regulatory framework surrounding COVID-19 vaccine development in the USA. The article, published by Jama Network, underscores the paramount importance of data-driven assessment of benefits and risks of vaccines. This echoes the call of Decide partners for more robust health technology assessment mechanisms.
More particularly, attempts at developing a COVID-19 vaccines in the US will occur against a backdrop of pressures from the political apparel, civic groups, economic and social forces. The challenge in this context will be for the FDA to apply the same quality standards, while dealing with emergency, high expectations and an anxiety that permeates all strata of the public debate.
Standards for efficacy and safety must be high for any product designed to be administered to millions of healthy individuals in the hope that it will prevent illness in a fraction of them. The calculus is particularly challenging when such infection is often asymptomatic, sometimes mild, but in some cases severe or fatal.
The Emergency Use Authorization (EUA) developed by the FDA may help find a balance between the strict regulatory framework designed to guarantee a high level of quality and safety, and the need to implement public health measures as fast as possible.
Find out more about the stakes, the capacity of the regulatory framework to adjust to this unique situation as well as the options available to the FDA: Click here.