As stockpiles of Ebola vaccine are being built up around the world, Médecins sans Frontières has said more action is needed to ensure sufficient numbers of vaccinations are available for use in current and future outbreaks.
The international humanitarian organization, Médecins sans Frontières, has called for a new mechanism for pooling reserves of Ebola vaccine for use in future outbreaks, and says that the price of Merck’s recently approved Ervebo vaccine must be “fair and reasonable.”
Ervebo was granted a conditional approval by the European Medicines Agency on 11 November, and was then quickly prequalified by...
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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