US FDA's Peter Marks and industry execs discuss challenges in moving candidate vaccines to Phase II/III trials, including international regulatory alignment on clinical endpoints and other issues. J&J's Paul Stoffels says it is going to be a 'Herculean task' to conduct placebo-controlled studies in 30,000 to 100,000 people.
As COVID-19 vaccine candidates move into pivotal trials, developers and regulators are confronting new challenges, from getting a sufficient number of participants, to determining what will be needed to demonstrate safety and efficacy and how to deal with special populations.
The US FDA's Peter Marks, director of the Center for Biologics Evaluation and Research, and executives from companies developing COVID-19...
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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