Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.
Johnson & Johnson is going full throttle on twin fronts in hopes of getting a COVID-19 vaccine on the market by early next year. It has ramped up research and development processes to "unprecedented levels" and is expanding its global manufacturing capacity to be able to produce one billion doses of the vaccine.
The company announced on 30 March that it had selected a lead COVID-19 vaccine candidate from constructs it began working...
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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