Unlike the current EUA fact sheet, Spikevax’s approved labeling does not state that the vaccine may pose an increased risk of myocarditis ‘relative to other authorized or approved mRNA COVID-19 vaccines.’ Approval brings Moderna a priority review voucher, as did Comirnaty’s approval for BLA sponsor BioNTech.
Among the benefits for Moderna, Inc. in converting its COVID-19 vaccine emergency use authorization to an approved biologics license application was the ability to drop a negative comparison about myocarditis adverse events from its label.
Labeling for Spikevax, Moderna’s mRNA vaccine approved on 31 January, includes language in the warnings and precautions section about myocarditis...
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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