Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine
GAITHERSBURG, Md., Dec. 20, 2021 /PRNewswire/ --Novavax (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for Novavax' COVID-19 vaccine (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age and older. Upon authorization, NVX-CoV2373 will be marketed in the European Union (E.U.) as Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted).
"Novavax appreciates the CHMP's positive opinion concerning our vaccine, and we look forward to a decision from the European Commission," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "An authorization from the Commission would deliver the first protein-based vaccine to the E.U. during a critical time when we believe having choice among vaccines will lead to increased immunization."
The EMA recommendation follows a positive CHMP opinion based on an expedited review of the totality of manufacturing, preclinical, and clinical trial data submitted by the company, with the conclusion that the vaccine meets the stringent criteria set by the E.U. for efficacy, safety and quality. This included data from two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled almost 30,000 participants in the U.S. and Mexico, and achieved an overall efficacy of 90.4%, the results of which were published in the New England Journal of Medicine (NEJM)); and a trial with more than 14,000 participants in the U.K. that achieved an overall efficacy of 89.7%, the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile.
Novavax and the European Commission announced an advance purchase agreement (APA) for up to 200 million doses of Novavax' COVID-19 vaccine in August 2021. This filing leverages Novavax' manufacturing partnership with Serum Institute of India (SII), the world's largest vaccine manufacturer by volume, which will supply initial doses for the E.U. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.
Novavax and SII recently received emergency use authorization (EUA) in Indonesia and the Philippines, where it will be commercialized by SII under the trade name Covovax™. The companies also received emergency use listing for Covovax from the World Health Organization. The vaccine is also currently under review by multiple regulatory agencies worldwide, and the company expects to submit its complete chemistry, manufacturing and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) by the end of the year.
The brand name Nuvaxovid™ has not yet been authorized for use in the U.S. by the FDA.
Authorization in the U.S.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide.
About the NVX-CoV2373 Phase 3 trials
A trial conducted in the U.K. with 14,039 participants was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000 participants, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response in both studies.
About Matrix-M™ Adjuvant
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SOURCE Novavax, Inc.
Company Codes: NASDAQ-NMS:NVAX