Guidance on COVID-19 vaccine development and licensure appears to set a precedent in specifying the clinical efficacy rate for a product approval; agency also takes accelerated approval off the table for now and says emergency use authorization may be granted only after safety and efficacy have been demonstrated.
The US Food and Drug Administration has set a bar for sponsors to meet in developing COVID-19 vaccines: an efficacy rate of at least 50%. The recommendation is intended to ensure resources are not wasted on a vaccine of limited value and to garner public confidence so people get vaccinated, thereby increasing the likelihood of achieving herd immunity.
The agency set the effectiveness bar in its guidance, "Development and Licensure of Vaccines to Prevent COVID-19," issued on...
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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