Novavax seeks updated Emergency Use Listing from WHO for Nuvaxovid as booster in adults
US: Novavax has announced the submission of a request to the World Health Organization (WHO) to update the Emergency Use Listing (EUL) of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous and heterologous booster in adults aged 18 and older.
The request is supported by data from Novavax' Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a meaningful antibody response when used as a heterologous third booster dose.
In the Novavax-sponsored trials, following the booster, local and systemic reactions had a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, often seen with increased immunogenicity. Medically attended adverse events (AE), potentially immune-mediated medical conditions, and severe AEs occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.
Nuvaxovid has also been approved in the European Union, Japan, Australia, New Zealand, and Switzerland as a booster in adults aged 18 and older and is actively under review in other markets.
The WHO previously granted EUL for Nuvaxovid for adults aged 18 and older in December 2021.
The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.
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