US FDA not planning an advisory committee for Pfizer/BioNTech’s request for authorization in 12-15-year olds at this time, but CDC’s ACIP is likely to weigh how to balance timing of COVID vaccination with administration of other immunizations generally recommended for adolescents.
Pfizer Inc.’s request to expand use of its COVID-19 vaccine in adolescents will spur consideration by a US Centers for Disease Control and Prevention panel on how it should be administered relative to other inoculations on the adolescent immunization schedule.
On 9 April, Pfizer and partner BioNTech SE requested the US Food and Drug Administration amend the emergency use...
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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