Novavax (NVAX) Misses Q2 EPS by $1.12

Novavax (NVAX) and Serum Institute of India Announce Submission to Regulatory Agencies in India, Indonesia, Philippines for Emergency Use Authorization of Novavax' Recombinant Nanoparticle COVID-19 Va

August 5, 2021 4:06 PM EDT

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, with its partner, Serum Institute of India Pvt. Ltd. (SII), today announced that the companies have filed regulatory submissions for emergency use authorization of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant. The submissions were made to the Drugs Controller General of India (DCGI) and regulatory agencies in Indonesia and the Philippines.

"Today's submission of our recombinant nanoparticle COVID-19 vaccine, the first protein-based... More

Novavax (NVAX) Announces COVID-19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination

August 5, 2021 4:06 PM EDT

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced preliminary data demonstrating that a single booster dose of its recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant, NVX-CoV2373, given six months after an initial two-dose regimen, elicited a 4.6-fold increase in functional antibody titers. Additionally, functional ACE-2 binding inhibition antibodies cross-reactive with the Delta (B.1.617.2) variant were more than 6-fold higher than the primary vaccination series. Complete data from the study will be submitted to a peer review publication and posted to a preprint server.

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EU seals deal with Novavax for up to 200 million COVID-19 vaccines

August 4, 2021 9:30 AM EDT

By Francesco Guarascio

BRUSSELS (Reuters) -The European Commission has approved a supply contract with U.S. firm Novavax to buy up to 200 million doses of its potential COVID-19 vaccine, the Commission said on Wednesday.

The move is part of the EU's strategy to diversify its vaccine portfolio after the bloc betted heavily for the coming years on messenger RNA (mRNA) shots produced by Pfizer-BioNTech and Moderna.

"Our new agreement with Novavax expands our vaccine portfolio to include one more protein-based vaccine, a platform showing promise in clinical trials," EU health commissioner Stella Kyriakides said in a statement.

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Novavax (NVAX), European Commission Finalize Advance Purchase Agreement for up to 200 million doses of COVID-19 Vaccine

August 4, 2021 9:10 AM EDT

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has reached an agreement with the European Commission (EC) for the purchase of up to 200 million doses of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant. The agreement covers the purchase of up to 100 million doses of the vaccine with the option for an additional 100 million doses through 2023.

Novavax is working to complete its rolling... More

European Commission approves new contract for a potential COVID-19 vaccine with Novavax (NVAX)

August 4, 2021 9:10 AM EDT

Today, the European Commission has approved its seventh Advanced Purchase Agreement (APA) with a pharmaceutical company to ensure access to a potential vaccine against COVID-19 in Q4 of 2021 and in 2022.

Under this contract, Member States will be able to purchase up to 100 million doses of the Novavax (NASDAQ: NVAX) vaccine, with an option for 100 million additional doses over the course of 2021, 2022, and 2023, once reviewed and approved by EMA as safe and effective. Member States will also be able to donate vaccines to lower and middle-income countries or to re-direct them to other European... More