Commissioner’s comments were yet another sign that US FDA won’t clear a vaccine ahead of the election, but hours later the president suggests the White House may decline to clear the agency’s new guidance on emergency use authorization standards for COVID-19 vaccines, raising new concerns about political interference in any decisions.
It typically takes the US Food and Drug Administration weeks to months to review a vaccine application after it is submitted to the agency, Commissioner Stephen Hahn told Senators on 23 September when asked how long it will likely take the agency to reach a decision on a COIVD-19 vaccine once an application is filed.
The admission casts further doubt on the likelihood a COVID-19 vaccine could receive an approval or emergency use authorization before...
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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