Novavax
United States
829 articles with Novavax
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U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over
7/13/2022
Novavax, Inc. (Nasdaq: NVAX), today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and over.
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U.S. Government Secures 3.2 Million Doses of Novavax COVID-19 Vaccine
7/11/2022
Novavax, Inc. (Nasdaq: NVAX), today announced an agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to secure an initial 3.2 million doses of Novavax' COVID-19 vaccine (NVX-CoV2373) should it receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and a recommendation from the Centers for Disease Control and Prevention (CDC).
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Novavax Nuvaxovid™ COVID-19 Vaccine Conditionally Authorized in the European Union for Adolescents Aged 12 Through 17
7/5/2022
Novavax, Inc. (Nasdaq: NVAX), today announced that the European Commission (EC) has approved the expanded conditional marketing authorization (CMA) of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) for adolescents aged 12 through 17.
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Voting 19-2, the Vaccines and Related Biological Products Advisory Committee favored redesigning booster shots to include the coronavirus’ Omicron variant.
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Novavax COVID-19 Data Presented at FDA VRBPAC Meeting Demonstrates Broad Antibody Responses to Both Prototype and Omicron-Specific Variants
6/28/2022
Novavax, Inc. (Nasdaq: NVAX), today participated in the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee's (VRBPAC) meeting which resulted in a 19-2 vote to recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the U.S. beginning this fall.
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Novavax COVID-19 Vaccine Nuvaxovid™ Recommended for Expanded Conditional Marketing Authorization in the European Union by CHMP for Adolescents Aged 12 Through 17
6/23/2022
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) for adolescents aged 12 through 17.
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Novavax' Nuvaxovid™ COVID-19 Vaccine Receives Emergency Use Authorization in Taiwan for Use in Individuals Aged 18 and Over
6/23/2022
Novavax, Inc. (Nasdaq: NVAX), today announced that the Taiwan Food and Drug Administration has granted emergency use authorization (EUA) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine in individuals aged 18 years and over.
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While a handful of companies have dominated the COVID-19 vaccine market in the U.S. and Europe, a number of biotechs are continuing to develop vaccines to use as booster shots.
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Novavax COVID-19 Vaccine Nuvaxovid™ Provisionally Registered in Australia as a Booster in Individuals Aged 18 and Over
6/13/2022
Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Australian Therapeutic Goods Administration (TGA) has granted provisional registration of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine as a booster in individuals aged 18 and over.
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GSK reported positive headline data from a pre-specified efficacy interim analysis of the Phase III trial of its RSV vaccine.
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The FDA plans to review changes to Novavax’s manufacturing process before it authorizes its vaccine.
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On Tuesday, the FDA's Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
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FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older
6/7/2022
Novavax, Inc. (Nasdaq: NVAX), today announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.
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The FDA has expressed worries over four cases of heart inflammation, or myocarditis, that were observed in pivotal clinical trials of Novavax's COVID-19 vaccine.
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Children under the age of five could be eligible to receive Pfizer-BioNTech's vaccine against COVID-19 as soon as late June.
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The FDA's Vaccines and Related Biological Products Advisory Committee is set to review clinical data on June 7 and potentially suggest approval of NVX-CoV2373.
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Despite posting its first profitable quarter as a commercial stage company, shares of Novavax plunged 20% in Tuesday trading due to the slower-than-expected rollout of its COVID-19 vaccine.
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Novavax Reports First Quarter 2022 Financial Results and Operational Highlights
5/9/2022
Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the first quarter ended March 31, 2022.
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Novavax to Participate in BofA Securities 2022 Healthcare Conference
5/4/2022
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that it will participate in BofA Securities 2022 Healthcare Conference.
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Novavax to Host Conference Call to Discuss First Quarter 2022 Financial Results and Operational Highlights on May 9, 2022
5/2/2022
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced it will report its first quarter 2022 financial results and operational highlights on Monday, May 9, 2022, following the close of U.S. financial markets.