European Commission Approves Novavax's Adapted COVID-19 Vaccine for Winter Season

The European Commission has granted approval for the Nuvaxovid XBB.1.5-adapted COVID-19 vaccine, a groundbreaking step in the fight against the ever-evolving pandemic. Developed by Novavax, this marks the first protein-based vaccine tailored to address the unique challenges posed by the autumn-winter season.

In a meticulous evaluation process, the European Medicines Agency (EMA) conducted a thorough assessment of the adapted vaccine. Following this evaluation, the European Commission fast-tracked its authorization to ensure that Member States have ample time to prepare for their upcoming autumn-winter vaccination campaigns.

Consistent with prior recommendations from the EMA and the European Center for Disease Prevention and Control (ECDC), adults and adolescents aged 12 and older, requiring vaccination, are strongly encouraged to receive a single dose. This guidance applies regardless of their previous COVID-19 vaccination history.

Novavax's achievement in adapting its COVID-19 vaccine to specifically target the SARS-CoV-2 Omicron strain XBB.1.5 aligns with the updated guidance provided by the ECDC and EMA regarding the composition of COVID-19 vaccines in response to new SARS-CoV-2 variants. This adapted vaccine is anticipated to broaden the scope of immunity, addressing both prevailing and emerging variants, as highlighted in the EC's official press release.