CDC’s advisory committee also approves a VFC program update allowing for the rare, off-label use of tetanus toxoid- and diphtheria toxoid-containing vaccine in young children, and plans to move up timing of its COVID-19 vaccine recommendations for the 2024-2025 formulation.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted on 28 February on use of the first approved chikungunya virus vaccine for several groups of people.
Valneva SE’s Ixchiq received accelerated approval on 9 November for prevention of disease caused by chikungunya virus in individuals...
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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