Multiple COVID-19 vaccines, including from RDIF and Novavax, could get accelerated approvals in India in the first half of calendar 2021, expanding the range at the country’s disposal. J&J's vaccine is expected to follow although it still hasn’t begun local trials, while Pfizer has temporarily withdrawn an application.
After conditional accelerated approvals were granted in India to AstraZeneca PLC/Serum Institute of India Pvt. Ltd. and separately to Bharat Biotech's COVID-19 vaccines in January, the next lot of contenders is getting set for approvals in the first half of calendar 2021.
The Russian Direct Investment Fund (RDIF), Novavax, Inc., Zydus Cadila and Baylor College of Medicine are among...
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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