Based on the historical time between Phase III results and filing announcements, AstraZeneca is way behind the pace. The firm will soon have waited longer to submit its EUA to the US FDA than the three already-authorized products waited combined.
AstraZeneca PLC still intends to apply for a US Food and Drug Administration emergency use authorization of its coronavirus vaccine, but preparations are taking longer than predecessors, potentially influenced by the appearance of rare blood clots among recipients.
Thirty-one days have passed since the company announced positive interim Phase III data for its proposed vaccine, AZD1222, on 22...
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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