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Found 106 articles

  • Novavax’s Protein-based Non-mRNA COVID-19 Vaccine

    Novavax’s Protein-based Non-mRNA COVID-19 Vaccine Available Now as Additional Dose for Individuals Aged 65 and Older Following U.S. CDC Advisory Committee Recommendation

    • 29 Feb 2024
    • Editor

    Today, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor (11 to 1; 1 abstain) to recommend that individuals aged 65 and older should receive an additional dose of 2023-2024 Formula COVID-19 vaccine (four months since receipt of the last dose).

  • Novavax’s Updated COVID-19 Vaccine Now Available i

    Novavax’s Updated COVID-19 Vaccine Now Available in Austria

    • 11 Dec 2023
    • Editor

    Novavax’s updated protein-based non-mRNA COVID-19 vaccine is now available for use in Austria for the prevention of COVID-19 in individuals aged 12 and older.

  • Novavax’s Updated COVID-19 Vaccine Now Available i

    Novavax’s Updated COVID-19 Vaccine Now Available in Germany

    • 11 Dec 2023
    • Editor

    Novavax’s updated protein-based non-mRNA COVID-19 vaccine is now available for use in Germany for the prevention of COVID-19 in individuals aged 12 and older.

  • Novavax's Updated COVID-19 Vaccine Now Authorized

    Novavax's Updated COVID-19 Vaccine Now Authorized in Canada

    • 6 Dec 2023
    • Editor

    Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that Health Canada has granted expanded authorization for Nuvaxovid™ XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older.

  • Novavax's Updated Nuvaxovid™ COVID-19 Vaccine Rece

    Novavax's Updated Nuvaxovid™ COVID-19 Vaccine Receives Positive CHMP Opinion in the EU

    • 1 Nov 2023
    • Editor

    Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) has been recommended for approval for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older in the European Union by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

  • Moderna Announces First Participant Dosed in Phase

    Moderna Announces First Participant Dosed in Phase 3 Study of mRNA-1083, a Combination Vaccine Against Influenza and COVID-19

    • 25 Oct 2023
    • Editor

    Moderna, Inc. (NASDAQ:MRNA) today announced that the first participant has been dosed in a Phase 3 study of the Company's combination vaccine candidate against influenza and COVID-19 (mRNA-1083) in the U.S. The trial is expected to enroll approximately 8,000 adults in the Northern Hemisphere.

  • Novavax Receives Full Marketing Authorization for

    Novavax Receives Full Marketing Authorization for Prototype COVID-19 Vaccine Nuvaxovid™ ▼ in United Kingdom

    • 19 Oct 2023
    • Editor

    Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has granted full marketing authorization for its prototype COVID-19 vaccine Nuvaxovid™ ▼ (NVX-CoV2373) for individuals aged 12 and older for active immunization to help prevent COVID-19.

  • U.S. Government Secures 3.2 Million Doses of Novav

    U.S. Government Secures 3.2 Million Doses of Novavax COVID-19 Vaccine

    • 11 Jul 2022
    • Editor

    Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced an agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense.

  • Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emer

    Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

    • 20 Jun 2022
    • Editor

    Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age).

  • Moderna Receives FDA Authorization for Emergency U

    Moderna Receives FDA Authorization for Emergency Use of its COVID-19 Vaccine for Children 6 Months of Age and Older

    • 20 Jun 2022
    • Editor

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine (mRNA-1273) in young children ages 6 months through 5 years of age at a dose level of 25 µg. The company has also received emergency use authorization for a 50 μg two-dose regimen of mRNA-1273.

  • Novavax COVID-19 Vaccine Nuvaxovid™ Provisionally

    Novavax COVID-19 Vaccine Nuvaxovid™ Provisionally Registered in Australia as a Booster in Individuals Aged 18 and Over

    • 14 Jun 2022
    • Editor

    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.

  • FDA Advisory Committee Recommends Emergency Use Au

    FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older

    • 8 Jun 2022
    • Editor

    Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, 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,

  • Evusheld significantly prevented COVID-19 disease

    Evusheld significantly prevented COVID-19 disease progression or death in TACKLE Phase III treatment trial

    • 8 Jun 2022
    • Editor

    Detailed results from the TACKLE Phase III outpatient treatment trial showed AstraZeneca’s Evusheld (tixagevimab and cilgavimab, formerly AZD7442) provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo, with treatment with Evusheld earlier in the disease course leading to more favourable outcomes.1

  • Novavax Initiates Phase 3 Trial of its COVID-19 Om

    Novavax Initiates Phase 3 Trial of its COVID-19 Omicron Strain Vaccine as a Booster

    • 1 Jun 2022
    • Editor

    Novavax today announced the initiation of its Phase 3 strain change trial to determine if its Omicron variant specific vaccine, NVX-CoV2515 (Omicron BA.1 strain), induces superior antibody responses against the Omicron variant compared to its Wuhan prototype vaccine, NVX-CoV2373, in participants who have received either a primary (two doses) or booster (three doses) series of an mRNA vaccine.

  • Vaxzevria approved in the EU as third dose booster

    Vaxzevria approved in the EU as third dose booster against COVID-19

    • 24 May 2022
    • Editor

    AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults.

  • AstraZeneca signs licence agreement with RQ Biotec

    AstraZeneca signs licence agreement with RQ Biotechnology for monoclonal antibodies against COVID-19

    • 18 May 2022
    • Editor

    AstraZeneca has entered into a licence agreement with RQ Biotechnology Ltd (RQ Bio) for a portfolio of early-stage monoclonal antibodies (mAbs) targeted against SARS-CoV-2, the virus that causes COVID-19.

  • Pfizer and BioNTech Granted U.S. Emergency Use Aut

    Pfizer and BioNTech Granted U.S. Emergency Use Authorization for Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age

    • 18 May 2022
    • Editor

    Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age.

  • FDA Approves Lilly and Incyte's OLUMIANT® (baricit

    FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients with COVID-19

    • 12 May 2022
    • Editor

    Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) with a recommended dose of 4-mg once daily for 14 days or until hospital discharge, whichever comes first.

  • Pfizer and BioNTech Submit Application for U.S. Em

    Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age

    • 27 Apr 2022
    • Editor

    Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12).

  • CureVac and GSK's Bivalent Second-Generation mRNA

    CureVac and GSK's Bivalent Second-Generation mRNA Vaccine Candidate Shown to be Highly Effective Against SARS-CoV-2 Variants in Preclinical Study

    • 21 Apr 2022
    • Editor

    CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced preclinical data demonstrating immune responses and protective efficacy of a bivalent second-generation COVID-19 vaccine candidate jointly developed with GSK, combining two mRNAs encoding for the Beta and the Delta variant.