Novavax Reports Extended Interim Authorization for Adolescents in Singapore

Novavax (NASDAQ:NVAX), Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that the Singapore Health Sciences Authority (HSA) has granted extended interim authorization and the Ministry of Health has included Nuvaxovid™ (NVX-CoV2373) into the National Vaccination Programme as a non-mRNA option for adolescents aged 12 through 17 for active immunization to prevent COVID.

"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.

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

Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been approved or licensed by the U.S. FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) as a primary series in individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Authorized Use
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

.