Decision to allow boosters for 12- to 15-year-old recipients of the Pfizer/BioNTech vaccine will go before CDC's ACIP, but like several other recent changes for COVID vaccines, the US FDA opted to skip its advisory committee.
In what is becoming a familiar routine, the US Food and Drug Administration expanded the emergency use authorization for the Pfizer Inc./BioNTech SE coronavirus vaccine to allow more groups to receive an additional dose, as well as shortened the time between the primary series and third shot, without an advisory committee meeting.
Children age 12 to 15 now are eligible for a booster shot of the Pfizer/BioNTech vaccine, the FDA announced on...
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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