Singapore HSA Extends Interim Authorization To Novavax's COVID Vaccine For Adolescents
(RTTNews) - Novavax, Inc. (NVAX) announced Friday 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 Program as a non-mRNA option for adolescents aged 12 through 17 for active immunization to prevent COVID.
The extended interim authorization was based on data from the pediatric expansion of the Phase 3 PREVxENT-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 neutralizing 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.
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