Gaithersburg-Based Novavax Receives Emergency Use Authorization for COVID-19 Vaccine in India

Gaithersburg’s Novavax has received emergency use authorization in India just one week after the European Union authorized the use of Novavax Inc.’s Covid-19 vaccine for adults.

On December 23, Novavax announced that early data showed its vaccine protects against the Omicron variant of Covid-19 and in early November the company announced it had received emergency authorization in Indonesia.

In an early December meeting, the City of Gaithersburg unanimously approved Novavax’s development plan.

Per Shulman Rogers, Novavax secured two sites in the City of Gaithersburg and obtained zoning approvals for a 180,000 square feet Global Headquarters and manufacturing facility delivering late summer at 700 Quince Orchard, and an additional 600,000+ square feet integrated campus next door at 14 Firstfield Road for expansion of its manufacturing and research and development capacity.

Last year, the State of Maryland announced it would assist with project costs related to the expansion. The Maryland Department of Commerce approved a $2 million conditional loan contingent on job creation and capital investment. In addition, the state approved a $200,000 Partnership for Workforce Quality training grant, and the company was deemed eligible for several tax credits, including the Job Creation Tax Credit and More Jobs for Marylanders.

Full press release in the emergency authorization in I dis can be seen below.

and PUNE, India, Dec. 28, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, today announced that the Drugs Controller General of India (DCGI) has granted emergency use authorization (EUA) for Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The vaccine will be manufactured and marketed in India by SII under the brand name Covovax™.

“No one is safe until everyone is safe, and today’s authorization marks a vital step for India, where additional vaccine options and millions of doses are needed in the country’s ongoing efforts to control the pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Novavax and SII will not rest in our partnership to deliver our vaccine to those in India and across the globe, as we work to protect the health of people everywhere.”

Because the vaccine is stored with standard refrigeration at 2° to 8° Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas.

“The approval of Covovax in India marks a significant milestone in strengthening our immunization efforts across India and LMICs,” said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. “We are proud to deliver a protein-based COVID-19 vaccine, based on Phase 3 clinical data demonstrating more than 90% efficacy and a favorable safety profile, to our nation.”

The Novavax/SII vaccine recently received EUA in Indonesia and the Philippines, as well as Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax was also granted Conditional Marketing Authorization by the European Commission and EUL with the WHO for its vaccine, which will be marketed by Novavax as NuvaxovidTM.  Novavax has also announced regulatory filings for its vaccine in multiple countries worldwide, while partners SK bioscience and Takeda have submitted regulatory filings in South Korea and Japan, respectively. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

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