US FDA’s biologics center director Peter Marks discusses future COVID-19 vaccine trials, post-market safety monitoring, and how FDA is juggling reviewing two emergency use authorization requests at once in an interview with Pink Sheet.
The US Food and Drug Administration will likely want sponsors to pivot from placebo-controlled trials to studies with active comparators once there is adequate supply of highly efficacious COVID-19 vaccines, Center for Biologics Evaluation and Research Director Peter Marks said.
“It would not be ethical at that point,” Marks said in an interview at the FDA-CMS Summit on 7 December.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
US FDA’s 2015 accelerated approval called for confirmatory trial completion by 2018, but study initiation was delayed. Completed in 2022, the trial not only verified Bexsero’s clinical benefit, it also served as the pivotal study for GSK’s pentavalent meningococcal vaccine candidate.
To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.
The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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