Updated EUA for mRNA COVID-19 vaccines left CDC room to define the type of conditions that meet the immunocompromised level described by the FDA. The recommendation for a third shot for immunocompromised patients was based on small studies using surrogates for vaccine efficacy, not hard clinical outcomes.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously 13 August in favor of administering a third Pfizer Inc. or Moderna, Inc. COVID-19 mRNA vaccine in immunocompromised people, barely 12 hours after the Food and Drug Administration amended the products' emergency use authorization.
The CDC’s recommendations – signed by Director Rochelle Walensky a few hours after the ACIP vote – flesh out in...
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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