Immunizations with Nuvaxovid™ to begin in coming days
Gaithersburg-Based Novavax has started shipping its Nuvaxovid Covid-19 vaccine to European countries, according to a press release from earlier this week.
Novavax
Per Novavax:
GAITHERSBURG, Md., Jan. 31, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.
Gaithersburg’s Novavax and Israel Announce Advance Purchase Agreement for Supply of COVID-19 Vaccine
The Novavax vaccine would be the first protein-based alternative available in Israel
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company based in Gaithersburg dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Israel’s Ministry of Health today announced an agreement for the purchase of NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant.
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Two weeks ago, Gaithersburg-based Novavax received approval for its Covid-19 Vaccine from the South Korean food and drug administration and filed for emergency use authorization in South Africa. In late December it received emergency authorization in India, and earlier this week Novavax announced its Australian approval.
Additional information can be found in the press release below:
GAITHERSBURG, Md., Dec. 31, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request to the U.S. Food and Drug Administration (FDA) for NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. Novavax expects to submit a request for EUA for the vaccine in the U.S. in one month in accordance with guidance from the FDA regarding submission of all EUA vaccines.
“Novavax is committed to delivering our protein-based vaccine in the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the U.S. Government for its ongoing support of our COVID-19 vaccine program, as well as our clinical trial participants and those who have supported the development and manufacturing of our vaccine.”
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.
In an early December meeting, the City of Gaithersburg unanimously approved Novavax’s development plan.
– Two-dose primary regimen of NVX-CoV2373 demonstrated cross-reactive immune responses against Omicron (B.1.1.529) and other variants
– Third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise and a 19.9-fold ACE2 inhibition increase after booster dose
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:
The Gaithersburg City Council approved unanimously approved Novavax’s development plan at Monday’s meeting.
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.
Novavax, a Gaithersburg-based 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 National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Peng was Obat dan Makanan (Badan POM), has granted emergency use authorization (EUA) for Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name COVOVAX™.
“The first authorization of Novavax’ COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which despite being the fourth most populous nation on earth, continues to work to procure sufficient vaccine for its population,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “This also marks the first regulatory authorization worldwide of a protein-based COVID-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favorable safety profile. This is a landmark moment for Novavax and our partner, Serum Institute of India, and it is the first of many authorizations that Novavax expects in the coming weeks and months for our vaccine globally.”
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GAITHERSBURG, Md., Oct. 27, 2021/PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the completion of its rolling regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of its COVID-19 vaccine candidate. The company’s application for Conditional Marketing Authorization (CMA) marks the first submission for authorization of a protein-based COVID-19 vaccine in the United Kingdom.
“This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine, built on a proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We look forward to MHRA’s review and will be prepared to deliver vaccine doses following what we anticipate will be a positive decision. We thank the clinical trial participants and trial sites in the United Kingdom, as well as the U.K. Vaccines Taskforce, for their support and vital contributions to this program.”