Concerns about cases of heart muscle inflammation occurring in older male adolescents and young men shortly after the second dose of Pfizer and Moderna mRNA vaccines hung over FDA advisory committee discussions on pediatric safety data requirements for COVID-19 vaccines; CDC’s ACIP will take up the myocarditis issue at an 18 June meeting.
An imbalance in myocarditis reports following mRNA vaccination could complicate expansion of the Pfizer Inc./BioNTech SE and Moderna, Inc. COVID-19 vaccines into younger age groups in the US.
Concerns about cases of myocarditis, inflammation of the heart muscle, occurring in older male adolescents and young men shortly after...
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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