Citing considerations of simplification, implementation and equity, Advisory Committee on Immunization Practices says everyone ages ≥50 years should get an mRNA vaccine booster dose and recommends all individuals ≥18 years have the option of getting one, without regard to occupational exposure or underlying medical conditions.
With the US Food and Drug Administration’s newly broadened emergency use authorization for the Pfizer Inc./BioNTech SE and Moderna, Inc. COVID-19 vaccines in hand, a Centers for Disease Control and Prevention panel voted on 19 November to expand recommended use of the mRNA vaccine booster doses and simplify determinations for eligibility.
The Advisory Committee on Immunization Practices recommended extending the option to get a single booster dose to all individuals ages...
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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