The government is paying a premium for updated vaccines despite the much smaller data packages that will be available at the time of a potential authorization and rollout. The administration also currently lacks funding for boosters for all, but demand may not necessitate such a supply.
The US government announced 29 July it has secured 66 million doses of Moderna, Inc.’s bivalent Omicron-BA.4/BA.5 directed COVID-19 vaccine for $1.74bn, bringing the total US supply of updated booster shots to 171 million – about enough to cover half of the US population in the planned fall booster campaign.
The Biden administration pulled money from other COVID-19 efforts like at-home testing to purchase the new vaccines. It has options...
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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