US FDA was trying to focus people on a one-booster-per year, updated fall COVID vaccine campaign to address what they perceive as the public’s inoculation exhaustion, but as BA.5 seems to be sending the US into another surge the White House is pushing a summer booster campaign.
The BA.5 COVID-19 surge is set to collide with an under-immunized American population this summer, forcing the Biden administration to grapple with dueling realities: more Americans need added protection now to ensure the best possible health outcomes in this wave, but encouraging those shots might diminish appetite for more up-to-date vaccines that should be available this fall.
This spring FDA said their focus was to move away from pushing COVID boosters multiple times a year to reduce...
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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