CDC’s ACIP members say goal for now should not be preventing infection. FDA’s Doran Fink notes that the agency will act diligently on EUA of vaccines in children under five once it receives submissions, cites the complexity of reviewing Novavax’s EUA request for its vaccine.
The Centers for Disease Control and Prevention convened its Advisory Committee on Immunization Practices to get their input on the best approach to COVID-vaccine booster shots. ACIP members emphatically agreed that the goal for future doses of vaccines should be to prevent severe disease and death rather than prevention of infection.
“We should not chase the rainbow” of hoping currently available vaccines “could prevent infection, transmission and even mild disease because...
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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