The US missed even its revised year-end target for COVID vaccines, but the news isn’t all bad; there’s steady progress on clinical research even as federal officials seem out of ideas for how to speed actual vaccinations.
Operation Warp Speed has run into some engine trouble. After helping drive development of a COVID vaccine in record time, OWS ended up falling short of its stated goal of vaccinating 20 million Americans by the end of 2020 – and even missed its revised goal of distributing 20 million doses of vaccine, shipping instead 14 million.
US government officials say that 20 million doses were indeed “allocated” by the end of the year, and that distribution...
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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