Novavax Inc (Nasdaq: NVAX), a biotechnology company, announced on Friday that it has received expanded conditional marketing authorisation (CMA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the company's Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunisation in adolescents aged 12 through 17.
The product will be the first protein-based vaccine available for adolescents aged 12 through 17 in the UK.
The approval was granted based on data from an ongoing Phase 3 PREVENT-19 trial of 2,247 adolescents assessing the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. The company achieved its primary effectiveness endpoint and showcased 80 percent clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in its pediatric expansion.
The vaccine now requires policy recommendation for use from the UK Joint Committee on Vaccination and Immunisation (JCVI) before becoming available.
Renew Biotechnologies names new chief operating officer
Teva, Sanofi accelerate inflammatory bowel disease drug trial
Ro adds David B Allison to Advisory Board
Charles River Laboratories and Autobahn Labs forge alliance to boost academic drug discovery
Nkarta partnering with Columbia on investigator-led lupus trial for NKX019
Gilead's lenacapavir demonstrates 100% efficacy in HIV prevention trial
Anixa Biosciences' ovarian cancer CAR-T therapy individual patient IND receives FDA approval
Evergreen Nephrology names new director
Emmaus Life Sciences names new chief executive officer
FDA feedback boosts Diamyd Medical's pathway to accelerated approval for Type 1 Diabetes Therapy
TC BioPharm (Holdings) doses sixth patient in TCB-008 clinical trial
Caidya names new chief executive officer
Ionis Pharmaceuticals reports positive results for ION582 in Angelman syndrome study
Nuvalent launches HEROEX-1 trial for HER2-selective inhibitor NVL-330
Astellas and Osaka University collaborate on stem cell therapy for disc degeneration