Drug Approval | October 06, 2021
EMA authorises booster dose of Moderna’s Spikevax
A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects
A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects
The 462,000 square foot state-of-the-art building targeting LEED Zero certification and is designed to be the most sustainable commercial lab building in Cambridge
saRNA is a new platform for the development of medicines and vaccines which uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level
In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after the administration of the second dose
The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
CDSCO gives the green signal as HGCO19 was safe, tolerable and immunogenic in the participants of the study
The preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureVac and GSK compared to CureVac’s first-generation mRNA backbone
Studies include Alpha, Beta, Gamma, Delta, Epsilon and Iota and it maintains antibodies for six months after the second dose
The collaboration will support Canada with direct access to rapid pandemic response capabilities
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