Foreign
U.S. biotechnology Company Novavax has applied to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of its protein-based COVID-19 shot as a booster for adults.
The vaccine is designed to prevent COVID-19 caused by the severe acute respiratory syndrome SARS-CoV-2 as a homologous and heterologous booster in adults aged 18 and older, the company said on Monday.
If authorised, Novavax’ vaccine would be the first protein-based COVID-19 booster for adults.
This application for EUA is supported by data from Novavax’ Phase III PREVENT-19 trial conducted in the United States and Mexico, and from the British-sponsored COV-BOOST Phase II trial.
As part of an open-label booster phase of the PREVENT-19 trial, a single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was administered to healthy adult participants at least six months after their primary two-dose vaccination series of the Novavax COVID-19 Vaccine, Adjuvanted.
The third dose produced robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series Phase 3 clinical trials.
In the COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted induced a significant antibody response when used as a heterologous third booster dose.
However, safety reporting of reactogenicity events shows an increasing incidence across all three doses of the Novavax COVID-19 Vaccine, Adjuvanted, reflecting the increased immunogenicity seen with a third dose.
Doses of the Novavax COVID-19 Vaccine, Adjuvanted have been available for use in the U.S. since July.(dpa/NAN)
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Tags: Emergency Use Authorisation (EUA) Novavax U.S. Food and Drug Administration (FDA)
