Sanofi/GSK's vaccine is under review in the EU and the UK government has awarded a grant to a company to allow it to increase its production of a key component of mRNA vaccines. Also, EU member states have proposed ways of improving the supply and donation of COVID-19 vaccines, including for those fleeing the conflict in Ukraine. Germany’s InflaRx has reported “encouraging” results with its anti-inflammatory drug vilobelimab in seriously ill patients.
The European Medicines Agency has begun assessing a conditional marketing authorization application (MAA) filed by Sanofi and GlaxoSmithKline plc for their COVID-19 vaccine, Vidprevtyn.
The vaccine is an adjuvanted recombinant protein-based product that includes an S-protein antigen from Sanofi and an adjuvant platform from...
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.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
