On September 13, 2024, Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, announced that doses of the Novavax COVID-19 Vaccine, Adjuvanted (2024–2025 Formula; NVX-CoV2705) to prevent COVID-19 in individuals aged 12 years and older are in stock at major pharmacy retailers across the United States.

Through agreements with pharmacies, Novavax’s updated vaccine is expected to be widely available in locations including, but not limited to, CVS Pharmacy, Rite Aid, Walgreens, Costco, Publix, Sam’s Club, Kroger, Meijer, and hundreds of other regional grocers and thousands of independent pharmacies. Novavax’s updated vaccine received Emergency Use Authorization (EUA) on August 30, 2024 from the FDA.

“We have worked hard to ensure greater ease of access for consumers this vaccination season by more than doubling the number of locations stocking our vaccine compared to last year and offering a more convenient presentation in a pre-filled syringe,” said John C. Jacobs, president and CEO, Novavax. “Our vaccine targets JN.1, the ‘parent strain’ of those currently circulating, and our vaccine has demonstrated cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1”

Novavax’s vaccine is the only protein-based option available in the U.S. this fall and is in pre-filled syringe presentation. Doses of Novavax’s vaccine can be located at us.novavaxcovidvaccine.com.

AUTHORIZED USE IN THE U.S.

Novavax COVID-19 Vaccine, Adjuvanted (2024–2025 Formula) has not been approved or licensed by the FDA but has been authorized for emergency use by the FDA, under an EUA to prevent COVID-19 for use in individuals aged 12 years and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.

The EUA of this product will remain in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the authorization is revoked sooner.

VACCINE AUTHORIZATION (U.S.)

Novavax COVID-19 Vaccine, Adjuvanted (2024–2025 Formula) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged 12 years and older.

IMPORTANT SAFETY INFORMATION

Contraindications

• Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Warnings and Precautions

• Management of acute allergic reactions: appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of the Novavax COVID-19 Vaccine, Adjuvanted

• Myocarditis and pericarditis: clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted

• Syncope (fainting): may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting

• Altered immunocompetence: immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted

• Limitations of vaccine effectiveness: the Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.

Adverse Reactions

Solicited adverse reactions included: injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, and fever.

Reporting Adverse Events and Vaccine Administration Errors

The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html, by calling 1-800-822-7967 or send an email to info@vaers.org.

About the Novavax COVID-19 2024–2025 Formula (NVX-CoV2705)

NVX-CoV2705 is an updated version of Novavax’s prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax’s Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2°C to 8°C, enabling the use of existing vaccine supply and cold-chain channels.

About Matrix-M™ Adjuvant

When added to vaccines, Novavax’s patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable.2 The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.

References

  1. CDC. COVID data tracker: variant proportions. https://covid.cdc.gov/covid-data-tracker/#variant-proportions. Accessed October 8, 2024.
  2. Stertman L, Palm AE, Zarnegar B, et al. The Matrix-M™ adjuvant: a critical component of vaccines for the 21st century. Hum Vaccin Immunother. 2023;19(1):2189885.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.