Novavax COVID vaccine Nuvaxovid recommended for expanded conditional marketing authorization in EU for adolescents
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.;
Gaithersburg: Novavax, Inc. has announced that the Nuvaxovid (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) for adolescents aged 12 through 17. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its opinion on results from the Phase 3 PREVENT-19 clinical trial.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
"This recommendation brings us closer to offering adolescents in the EU the first protein-based COVID-19 vaccine developed using an innovative approach to traditional technology," said Stanley C. Erck, President and Chief Executive Officer, Novavax.
The CHMP recommendation was based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 trial of 2,247 adolescents aged 12 through 17 across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.
Read also: Novavax COVID vaccine gets emergency use nod in Taiwan for adults
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.