The World Health Organization (WHO) has issued an updated Emergency Use Listing (EUL) for 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 primary series of two doses in adolescents aged 12 through 17 and as a booster in adults aged 18 and older.
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"Today's updated Emergency Use Listing from the WHO allows us to offer our protein-based vaccine as a primary series to adolescents and as a booster for adults around the world," said Stanley C. Erck, President and Chief Executive Officer, Novavax.
"WHO member countries now have a vaccine option for these indications developed using an innovative approach to traditional technology that can also be stored in standard refrigeration, making it easy to transport."
The updated EUL for Nuvaxovid as a primary series in adolescents aged 12 through 17 was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,232 adolescents aged 12 through 17 years across 75 sites in the U.S., to evaluate the safety and effectiveness of Nuvaxovid.
In the pediatric expansion, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.
Preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose.
The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents.
No new safety signal was observed through the placebo-controlled portion of the pediatric expansion.
The updated EUL for Nuvaxovid as a booster in adults aged 18 and older 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 United Kingdom (U.K.)-sponsored COV-BOOST trial.
As part of the Novavax 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.
In the 12 through 17-year-old population, Novavax' vaccine has been authorized in more than 10 markets including the U.S., the European Union (EU), and the U.K.
The vaccine has also been authorized as a booster in the U.S., EU, Japan, Australia, New Zealand, and Switzerland, and a number of other countries have policy recommendations allowing use of the vaccine as a heterologous or homologous booster dose.
Novavax' vaccine is actively under review in other markets for both indications and has ongoing trials to further explore its efficacy and safety as a booster.
The WHO previously granted EUL for Nuvaxovid in adults aged 18 and older in December 2021. ■