- The European Commission has approved the expanded conditional approval of Novavax Inc's 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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