Due to need to plan for potential vaccine boosters now, administration is focusing on contracting with the companies whose shots are already being given in the US, David Kessler tells the Senate health committee. Data on whether it is ok to ‘mix and match’ vaccine types with boosters should be available in a few months.
The US government plans to purchase and supply the next round of COVID-19 vaccines to Americans free of charge if boosters are needed in 2022, David Kessler, the Chief Science Officer for the COVID Response at the Department of Health and Human Services, told Congress.
Kessler, speaking at an 11 May Senate HELP Committee hearing said HHS already has enough funding from Congress to purchase...
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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