Moderna has submitted an application to Swissmedic, the national supervisory authority for drugs and medical products, to authorise the use of its Covid-19 vaccine in adolescents in Switzerland. Moderna’s Covid-19 vaccine met its primary immunogenicity endpoint in a Phase II/III TeenCOVE study of its vaccine in adolescents in May 2021, the company confirmed. It also announced it had filed for authorisation with the US Food and Drug Administration, the European Medicines Agency and Health Canada.
Humanigen, a clinical-stage biopharmaceutical company, has started a rolling review submission for marketing authorisation by the UK’s Medicines and Healthcare Products Regulatory Agency for its Covid-19 drug, lenzilumab. The company said it has already applied for emergency use authorisation in the US. The application follows results from the LIVE-AIR clinical study, which shows the drug to improve patient outcomes.
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New Public Health England (PHE) analysis has found that the Pfizer and AstraZeneca coronavirus vaccines offer high levels of protection against hospitalisation from the Delta variant, first identified in India. Prime Minister Boris Johnson has delayed the lifting of Covid-19 restrictions in England due to the highly transmissible Delta variant of concern, which is also linked with high risks of hospitalisation among the unvaccinated. PHE confirmed that the Pfizer-BioNTech and Oxford-AstraZeneca jabs are 96% and 92% effective against hospitalisations after two doses, respectively.
