The European Commission has approved Novavax Inc's (NYSE: NVAX) Nuvaxovid (NVX-CoV2373), following a positive opinion for a full authorization from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
The vaccine is now fully authorized as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older to prevent COVID-19.
The Covid-19 vaccine was Novavax's first and only commercial product in its 36-year history. However, it flopped after successful trials thanks to regulatory delays and manufacturing hiccups.
Nuvaxovid was initially granted a conditional nod in the EU for these indications.
The Phase 3 PREVENT-19 trial demonstrated Nuvaxovid's reassuring safety profile as well as efficacy as a primary series in adults, the immunogenicity and safety as a booster dose in adults, and the efficacy and safety as a primary series in individuals aged 12 and older.
Novavax's COVID vaccine is authorized for use in more than 40 markets worldwide but has not yet been approved by the FDA.
In June, Novavax's R&D chief Filip Dubovsky expressed confidence that the company's updated COVID-19 vaccine, already in production, will offer protection against the rapidly emerging coronavirus variants prevalent in the U.S.
In its Q1 earnings release, Novavax announced a global restructuring and cost reduction plan, expected to reduce annual combined 2024 R&D and SG&A expenses by approximately 40% to 50% versus 2022.
Price Action: NVAX shares are down 2.85% at $7.15 on the last check Thursday.