CDC developing vaccine distribution plans with four states and one large city that will serve as a ‘foundation’ for other jurisdictions; plans include provisions for all potential vaccines, but logistics will vary depending on product, especially given the cold chain issues associated with mRNA vaccines from Pfizer and Moderna.
The US Centers for Disease Control and Prevention’s distribution plans for a COVID-19 vaccine assume it would first enter the market under an emergency use authorization (EUA) from the Food and Drug Administration.
“For the purposes of our planning right now, we’re planning for the assumption that’s it an EUA,” CDC director Robert...
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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