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Novavax : Canada Approves Nuvaxovid COVID-19 Vaccine For Use As Primary Series In Adolescents

Novavax Inc. (NVAX) said that Health Canada has approved a supplement to a New Drug Submission for Nuvaxovid (COVID-19 Vaccine) (NVX-CoV2373) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 as a primary series of two doses in adolescents aged 12 through 17.

In the 12 through 17-year-old population, Novavax' vaccine has been authorized in more than 10 markets around the world including the U.S., the European Union, and the United Kingdom.

Health Canada previously approved Nuvaxovid as a primary series in adults aged 18 and older in February 2022 and as a homologous booster in adults in November 2022. In Canada, Nuvaxovid will be manufactured locally at the Biologics Manufacturing Centre in Montreal. Engineering runs have been successfully completed and manufacturing of process performance qualification batches is expected to begin in early 2023.

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

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