The EMA has issued updated safety advice on AstraZeneca’s COVID-19 vaccine, Vaxzevria, Valneva has decided to pursue vaccine supply deals with individual member states after a falling out with the European Commission, and Kazakhstan has begun administering the first doses of its domestically produced vaccine, QazVac.
A new project has been launched in Europe to strengthen the post-marketing monitoring of the safety, effectiveness and impact of coronavirus vaccines in real world circumstances.
Under the initiative. the European Medicines Agency and the European Centre for Disease Prevention and Control will jointly coordinate and...
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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