CBER Director Peter Marks told Janet Woodcock in an email that he thought reviewers were treating the BLA for the first fully approved COVID-19 vaccine as a conventional review or learning exercise.
A top US Food and Drug Administration official was frustrated with the pace of the review of Pfizer Inc./BioNTech SE’s COVID-19 vaccine Comirnaty in 2021, and appeared to push for the application to be approved several weeks earlier than staff wanted, agency emails reveal.
The trove of messages released by the agency show Center for Biologics Evaluation and Research Director Peter Marks telling...
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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