Overall benefit still favorable when there could be excess hospitalizations due to vaccine-related myocarditis because of ‘the different clinical implications of hospitalization for COVID-19,’ FDA concludes ahead of the advisory committee.
The US Food and Drug Administration appears to have concluded that Pfizer Inc.’s COVID vaccine should be authorized in children 5-11 even if a low incidence of infections mean the jabs create an excess number of hospitalizations for myocarditis relative to those prevented for the disease itself.
In briefing documents released ahead of the 26 October advisory committee review, FDA models several possible scenarios for the...
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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