Estimated $14 price per dose for Janssen’s investigational vaccine is first drop in value since Operation Warp Speed started signing contracts. The $1bn purchase order for 100 million doses and earlier $456m for development work is considerably less lucrative than the $2.1bn deal with GSK/Sanofi announced last week, especially since Janssen’s product may end up being a one-dose regimen.
The $1bn commitment from the US for 100 million doses of Johnson & Johnson’s coronavirus vaccine announced on 5 August is a hefty order – but only if you don’t compare it to the deal the government struck with GlaxoSmithKline plc and Sanofi the week before.
Under the agreement with the Janssen subsidiary, the US Health and Human Services Department and the Department of Defense will...
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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