The granting of CMA requires a positive benefit–risk balance, unmet medical needs to be fulfilled, likely submission of comprehensive data postauthorization, and the benefit of immediate availability to outweigh the risks of data noncomprehensiveness. Since its first use, more than half of all ...
announced that the China National Medical Products Administration (NMPA) has granted a conditional marketing authorization (CMA) to Sinovac for CoronaVac, Sinovac’s COVID-19 vaccine in individuals aged 18 and above.
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY® (also known as BNT162b2), for active immunization to prevent COVID-19 c...
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Novavax, Inc. announced its submission to Swissmedic, the Swiss Agency for Therapeutic Products, for conditional marketing authorization (CMA) of NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant, for use...
A CMA is granted where comprehensive clinical data is not yet complete, but it is judged that such data will become available soon. CMAs are valid for one year and renewable annually with ongoing regulatory review of data. About the Vertex and CRISPR Collaboration Vertex and CRISPR ...
(CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older inGreat Britain. The vaccine, also known as NVX-...
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Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but for which comprehensive data are not available. Using a mixed quantitative-qualita... J Hoekman,WPC Boon,JC Bouvy,... - 《Clinical Pharmacolog...