Novavax COVID vaccine Nuvaxovid gets extended interim authorization for adolescents in Singapore

"This news acknowledges the need to maintain access to a diverse COVID vaccine portfolio," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We are pleased with this adolescent authorization in Singapore as it ensures a protein-based option as part of public health measures."

Extended interim authorization was based on data from the pediatric expansion of the Phase 3 PREVENT-19 trial of 1,799 adolescents aged 12 through 17 years in the U.S., to evaluate the safety and effectiveness of Nuvaxovid. In the trial, Nuvaxovid achieved its primary endpoint based on neutralising antibody response and demonstrated clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.

Novavax's vaccine is authorized for use in more than 40 markets around the world. In Singapore, the HSA previously granted interim authorization for Nuvaxovid to prevent COVID-19 in adults aged 18 and older in February 2022.

The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration (FDA).

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NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.

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