FDA praised for pulling back on plans to host 15 February advisory committee review of Pfizer’s COVID-19 vaccine in children but faulted, along with other parts of US government, for raising expectations this month that the vaccine might be available for this population imminently.
The US Food and Drug Administration did a rapid about face on 11 February, canceling Pfizer Inc. and BioNTech SE’s 15 February advisory panel review of the sponsors' COVID-19 vaccine in children 6 months through 4 years of age saying the agency needed to review data on the impact of a third dose of the vaccine before making an authorization decision.
The sudden shift raised questions about why FDA so publicly hyped up the possibility of a faster-than-anticipated authorization in this...
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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