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Novavax’s Nuvaxovid COVID-19 Vaccine Receives the CHMP Recommendation for Expanded Conditional Marketing Authorization

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Novavax’s Nuvaxovid COVID-19 Vaccine Receives the CHMP Recommendation for Expanded Conditional Marketing Authorization

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  • The EMA has recommended expanding CMA for Nuvaxovid (NVX-CoV2373) as a homologous & heterologous booster to prevent COVID-19 in adults aged ≥18yrs.
  • The EMA’s CHMP was based on 2 P-II trials, and the UK-sponsored (COV-BOOST) trial in healthy adult patients received a single booster dose of Nuvaxovid about 6mos., following initial 2-dose Nuvaxovid immunization series
  • Nuvaxovid showed a robust Ab response as a heterologous 3rd booster dose in the (COV-BOOST) trial. Following the booster, local and systemic responses were typically transient in the Novavax-sponsored trials, lasting a median of 2 days, and grade ≥3 events remained low. All 3 doses of Nuvaxovid had an increasing rate of reactogenicity events consistent with the increased immunogenicity observed with the 3rd dose

Ref: Novavax | Image: Novavax

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Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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