Advisory Committee on Immunization Practices work group also says previous infection with SARS-CoV-2 should not exclude someone from receiving vaccine if they are in one of the early groups recommended for prioritization; ACIP group unveils updated ethical principles intended to guide vaccine allocation decisions.
Women who are pregnant or breastfeeding, and individuals previously infected with the novel coronavirus, should not automatically be excluded from COVID-19 immunization if they are included in groups prioritized for early allocation of vaccine, according to a US Centers for Disease Control and Prevention’s advisory committee working group.
On 30 October, the Advisory Committee on Immunization Practices continued to refine its prioritization strategy for groups that should be...
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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