The European Commission has approved the expanded conditional approval of Novavax Inc's (NASDAQ: NVAX) Nuvaxovid COVID-19 vaccine as a homologous and heterologous booster for adults aged 18 and older.
The approval follows the recommendation made by the European Medicines Agency's Committee for Medicinal Products for Human Use earlier this month.
The expanded approval was based on data from Novavax's Phase 2 trial conducted in Australia, a separate Phase 2 trial conducted in South Africa, and the UK-sponsored COV-BOOST trial.
The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 trials. In the COV-BOOST trial, Nuvaxovid induced a robust antibody response when used as a heterologous third booster dose.
In the Novavax-sponsored trials, local and systemic reactions were generally short-lived following the booster.
Nuvaxovid has also been authorized in Japan, Australia, and New Zealand as a booster in adults aged 18 and older and is actively under review in other markets.
Price Action: NVAX shares are up 1.73% at $32.27 on the last check Monday.
Photo by Jernej Furman via Flickr
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