In expanding authorization of booster doses for both mRNA vaccines, the agency updated Moderna’s fact sheet to state the vaccine appears to pose a higher risk of myocarditis/pericarditis in males under age 40 years after the second dose, although data are ‘not yet dispositive.’
Lost amid the fanfare of the US Food and Drug Administration’s recent decision to broadly authorize COVID-19 mRNA vaccine boosters for everyone 18 years and older was a quiet, but still notable, change in language on the myocarditis risk with Moderna, Inc.’s vaccine.
In conjunction with the expanded authorization, the Moderna health care provider fact sheet was updated to state that 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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