This section highlights FDA-related milestones and regulatory updates for drugs developed by Novavax (NVAX).
Over the past two years, Novavax has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Matrix-M, Nuvaxovid, and NVX-CoV2705. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Matrix-M - FDA Regulatory Timeline and Events
Matrix-M is a drug developed by Novavax for the following indication: for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Matrix-M
- Announced Date:
- December 10, 2024
- Indication:
- for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates.
Announcement
- Novavax, Inc. announced that the first participants have been dosed in its COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza Phase 3 trial.
AI Summary
Novavax, Inc. has started dosing the first participants in its Phase 3 trial for both its COVID-19-Influenza Combination (CIC) vaccine and a stand-alone seasonal influenza vaccine. The trial will assess how well these vaccines work and how safe they are, comparing them with Novavax’s updated COVID-19 vaccine and a licensed influenza vaccine. The study will include adults aged 65 and older to check if the combined vaccine can protect against both viruses. The company plans to work closely with the U.S. Food and Drug Administration (FDA) to explore the possibility of an accelerated approval pathway. Novavax’s goal is to get these new vaccines approved and to market as quickly as possible, potentially helping to improve public health by providing protection against two common vaccine-preventable diseases in one go.
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Nuvaxovid - FDA Regulatory Timeline and Events
Nuvaxovid is a drug developed by Novavax for the following indication: Covid-19.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Nuvaxovid
- Announced Date:
- June 11, 2025
- Indication:
- Covid-19
Announcement
Novavax, Inc. announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) Phase 3 trial that showed both the CIC and flu vaccine candidates induced immune responses similar to licensed comparators Nuvaxovid® and Fluzone HD, respectively.
AI Summary
Novavax recently shared positive results from the initial cohort of its Phase 3 trial evaluating two vaccine candidates. The trial looked at the COVID-19-Influenza Combination (CIC) vaccine and the stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) vaccine. Both candidates produced strong immune responses against multiple influenza strains and the COVID-19 antigen.
Importantly, the immune responses were comparable to those seen with licensed vaccines—Nuvaxovid® for COVID-19 and Fluzone HD for influenza. The trial results, which came from a group of participants aged 65 and older, also showed that both vaccines were well tolerated, with most side effects being mild or moderate. These findings support further development and potential partnership discussions as Novavax moves toward a broader Phase 3 program.
Read Announcement- Drug:
- Nuvaxovid
- Announced Date:
- October 9, 2024
- Indication:
- Covid-19
Announcement
Novavax, Inc. announced that the European Commission granted Marketing Authorization for Novavax's updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union (EU).
AI Summary
Novavax announced that the European Commission has granted Marketing Authorization for its updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for use in individuals aged 12 and older in the European Union. This approval followed a positive opinion from the Committee for Medicinal Products for Human Use at the European Medicines Agency. The updated vaccine is designed to target the JN.1 variant and its lineages, showing cross-reactivity against several strains. It employs Novavax’s protein-based vaccine technology along with the innovative Matrix-M™ adjuvant to boost and broaden the immune response. Packaged as a ready-to-use liquid formulation stored at 2° to 8°C, the vaccine is well-suited for use with existing supply chains and cold storage systems, helping support widespread immunization efforts against COVID-19 in the EU.
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NVX-CoV2705 - FDA Regulatory Timeline and Events
NVX-CoV2705 is a drug developed by Novavax for the following indication: Updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NVX-CoV2705
- Announced Date:
- August 30, 2024
- Indication:
- Updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant.
Announcement
Novavax, Inc. announced the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older.
AI Summary
Novavax announced that its updated COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for active immunization against COVID-19 in individuals aged 12 and older. This decision marks the vaccine as the only protein-based option available in the United States, using the Matrix‑M™ adjuvant to boost and broaden the immune response.
The vaccine is designed to target the JN.1 variant, recognized as the parent strain of many circulating variants, and is expected to provide robust cross-reactivity against several JN.1 lineage viruses. Packaged in pre-filled syringes, it will soon be accessible at thousands of locations nationwide, including retail and independent pharmacies, making it a key asset in ongoing public health efforts to prevent COVID-19.
Read Announcement- Drug:
- NVX-CoV2705
- Announced Date:
- June 14, 2024
- Indication:
- Updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant.
Announcement
Novavax, Inc. announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.
AI Summary
Novavax, Inc. has submitted an amendment to its Emergency Use Authorization with the FDA for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. The updated vaccine is designed to better protect against the currently circulating JN.1 lineage and closely related variant strains such as KP.2 and KP.3. This protein-based option, using Novavax’s unique recombinant nanoparticle technology and Matrix-M™ adjuvant, is expected to enhance and broaden the immune response, making it a valuable addition to the COVID-19 vaccine portfolio in the United States.
Novavax’s submission is aligned with guidance from the FDA, EMA, and WHO on vaccine composition. The company aims to have doses ready in the U.S. by mid-August for rapid distribution once authorization and CDC recommendations are in place, ensuring immediate availability during the upcoming vaccination season.
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