Arexvy is the first vaccine approved for the respiratory virus, but GSK's RSV program may lose out on a key population due to safety concerns for individuals younger than two. For Arexvy, CDC’s advisory committee could limit recommendation to 65 and up at June meeting.
GlaxoSmithKline Pharmaceuticals Ltd.won the first US approval for a respiratory syncytial virus vaccine on 3 May in older adults but looks like it may not be able to claim the same crown in the other key population impacted by the virus – infants and young children.
The Food and Drug Administration approval letter for GSK’s Arexvy says the agency is waiving the pediatric study requirement for...
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.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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.
