Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU).
A protein-based vaccine, Nuvaxovid has been recommended for MA for use as a primary series in individuals of the age 12 years and above and as a booster in those aged 18 years and older to prevent Covid-19.
NVX-CoV2373 is developed by making copies of the surface spike protein of the SARS-CoV-2 virus that causes Covid.
The spike protein that is non-infectious serves as the antigen that primes the immune system to identify the virus while the Matrix-M adjuvant of Novavax improves and widens the immune response.
The safety and efficacy of Nuvaxovid was evaluated as a primary series.
Novavax has also demonstrated the vaccine’s safety and immunogenicity as a booster in individuals aged 12 years and above in the Phase III PRE-fusion protein subunit Vaccine Efficacy Novavax Trial COVID-19 (PREVENT-19) trial, Phase II trials, and in real-world evidence.
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Conducted in the US and Mexico, the placebo-controlled, randomised, observer-blinded study PREVENT-19 evaluated the safety and efficacy of NVX-CoV2373 as a primary series and as a booster in adults and adolescents for preventing SARS-CoV-2 infection.
Novavax president and CEO John Jacobs said: “The positive CHMP Opinion for full Marketing Authorisation for our Covid vaccine brings us one step closer to full authorisation and will provide an approval pathway for an updated vaccine in time for the fall.”