CEPI Says Approved COVID-19 Vaccines Must Be Available for Clinical Trials

In a Sept. 7, 2021, letter, the Coalition for Epidemic Preparedness Innovations (CEPI) stated that developing the next generation of COVID-19 vaccines will only be possible if comparator vaccines—COVID-19 vaccines that have already been approved—are available for clinical trials. This next generation of vaccines need to address global supply and variants, and there is a growing need to compare efficacy of the comparator vaccines to the COVID-19 vaccine candidates.

The approval of COVID-19 vaccines has thus far been based on data from seronegative populations in placebo-controlled vaccine efficacy trials, according to CEPI. But these trials are difficult to conduct due to the rise in the number of people vaccinated or who previously had COVID-19. Therefore, CEPI states that comparator vaccines need to be used in trials of new vaccine candidates to replace placebos. Using comparator vaccines would also support comparing efficacy and immunobridging trials for registration of new vaccine candidates.

But the lack of access to comparator vaccines is a challenge, which stalls the development of vaccine candidates. CEPI encourages governments and vaccine manufacturers to broaden supply contracts to provide access to the comparator vaccines for these trials and to ultimately develop new vaccines.

Source: The Coalition for Epidemic Preparedness Innovations (CEPI)