Safety and immunogenicity data may not be sufficient to get FDA authorization of COVID-19 vaccines against a variant, FDA’s Doran Fink says. For now, agency expects to see clinical data. Eventually, strain changes might be based on manufacturing information.
The US Food and Drug Administration may not authorize a modified COVID-19 vaccine to protect against SARS-CoV-2 variants based solely on safety and immunogenicity data, and at least for now expects to see clinical data, FDA’s Doran Fink said.
Speaking at the National Vaccine Advisory Committee’s 17 June meeting, Fink, deputy director for clinical review in the Division of...
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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