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Nuvaxovid COVID 19 vaccine is filed in the European Union for expanded conditional marketing authorization.- Novavax.

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Published:21st May 2022

Novavax announced the submission of a request to the European Medicines Agency to expand the conditional marketing authorization (CMA) of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) as a homologous and heterologous booster dose for individuals aged 18 and over.

This request for expanded CMA is supported by data from Novavax’ Phase II trial conducted in Australia, from a separate Phase II trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial.

As part of the Phase II trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of NVX-CoV2373. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase III clinical trials. In the COV-BOOST trial, NVX-CoV2373 induced a robust antibody response when used as a heterologous third booster dose.

Following the booster, local and systemic reactions were generally short-lived with a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of NVX-CoV2373, reflecting the increased immunogenicity seen with a third dose.

Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose and were balanced between vaccine and placebo groups..

Condition: Coronavirus/COVID-19 Infection
Type: drug

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