Novavax $NVAX Gets EMA Thumbs Up for Conditional Marketing of its COVID-19 Vaccine

  • Post category:Biotechnology
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NVAX stock 4.6% in early trading on December 20, 2021, after the EMA recommended approval of its COVID-19 vaccine. Actual approval is expected soon.

EMA recommends Novavax’s Nuvaxovid for authorization in the EU

GAITHERSBURG, Md., Dec. 20, 2021 /PRNewswire/ — Novavax, Inc. (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.

Novavax, SII annuaonce WHO grants emergency use listing for NVX-CoV2373

On December 17, 2021, Novavax and Serum Institute of India announced that the World Health Organization has granted Emergency Use Listing for NVX-CoV2373, Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant, for active immunization of individuals 18 years of age and older for the prevention of coronavirus disease 2019 caused by SARS-CoV-2.

The EUL pertains to vaccine manufactured and marketed by SII as COVOVAX, a novel recombinant, adjuvanted SARS-CoV-2 rS Vaccine, in India and licensed territories. An additional EUL filing is under review by the WHO for vaccine to be marketed by Novavax under the brand name Nuvaxovid. The EUL prequalifies Novavax’ COVID-19 vaccine as meeting the established WHO standards for quality, safety and efficacy. EUL is a prerequisite for exports to numerous countries, including those participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.

The grant of EUL was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published December 15, 2021 in the New England Journal of Medicine; and a trial that evaluated the vaccine in more than 14,000 participants in the U.K., the results of which were published June 30, 2021 in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.

Novavax and SII recently received emergency use authorization for COVOVAX in Indonesia and the Philippines. The vaccine is also currently under review by multiple regulatory agencies worldwide. The company expects to submit its complete chemistry, manufacturing and controls data package to the U.S. FDA by the end of the year.

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📈 NVAX Stock Technical Analysis

Nvax Stock

The long term trend is still neutral, but the short term trend is positive, so the stock is getting more and more appreciated by traders and investors. NVAX is part of the Biotechnology industry. There are 625 other stocks in this industry. NVAX outperforms 92% of them. NVAX is currently trading in the middle of its 52 week range. The S&P500 Index however is trading in the upper part of its 52 week range, so NVAX is lagging the market slightly. There is a resistance zone ranging from 217.98 to 217.98. This zone is formed by a combination of multiple trend lines in multiple time frames. There is a support zone ranging from 143.01 to 144.05. This zone is formed by a combination of multiple trend lines in multiple time frames. NVAX has an average technical rating and it also does not offer a high quality setup at the moment. Prices have been extended to the upside lately. For a nice entry it is better to wait for a consolidation. Click here to sign up for email alerts on when NVAX stock is a good buy or sell on the chart.

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