European Union Approves Gaithersburg-Based Novavax Vaccine

Yesterday, the European Union authorized the use of Novavax Inc.’s Covid-19 vaccine for adults. This makes Gaithersburg-based Novavax’s two-dose vaccine the fifth of its kind to be approved in the European Union.

More information below from the Novavax press release:

• Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) is the first protein-based COVID-19 vaccine authorized for use in Europe
• Novavax and the European Commission previously announced an advance purchase agreement for up to 200 million doses through 2023
• Authorization follows positive recommendation by European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)

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 Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation today to authorize the vaccine (also known as NVX-CoV2373) and is applicable in all 27 European Union (E.U.) member states.

“We welcome today’s European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for the people of the E.U.,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the European Medicines Agency, the Committee for Medicinal Products for Human Use reviewers and the European Commission for their thorough assessment as we look forward to playing a critical role in helping to address the continued threat of COVID-19. We also thank the thousands of clinical trial participants, our partners and Novavax employees worldwide who have contributed to this historic milestone.”

The EMA opinion and related EC decision is 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 included 30,000 participants in the U.S. and Mexico, the results of which were published in The New England Journal of Medicine (NEJM); and a trial with 15,000 participants in the U.K., the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and an acceptable 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 the EC announced an advance purchase agreement (APA) for up to 200 million doses of Novavax’ COVID-19 vaccine in August 2021. Initial doses are expected to arrive in Europe in January.  Novavax is working with EMA and its partners to expedite local release testing.

This authorization 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.

Authorized Use of Nuvaxovid^™ in the European Union
European Commission has granted conditional marketing authorization for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

Important Safety Information

• Nuvaxovid^™ is contraindicated in persons who have a hypersensitivity to the active substance or to any of the excipients
• Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction
• Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress–related reactions may occur in association with vaccination as a response to the needle injection. It is important that precautions are in place to avoid injury from fainting
• Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection
• Give Nuvaxovid with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals
• The efficacy of Nuvaxovid may be lower in immunosuppressed individuals
• The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials
• Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients
• The most common adverse reactions observed during clinical studies (frequency category of very common ≥ 1/10), were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue and malaise