15 May 2023 | Monday | News
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"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.
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