• Modified agreement also includes the development of an updated vaccine in fall 2023

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced a modification to its existing agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373). This agreement will maintain the U.S. public's access to Novavax' vaccine and support the development of smaller dose vials, strain selection in line with U.S. Food and Drug Administration (FDA) recommendations, and a smooth transition to the commercial market.

"This agreement acknowledges the need to offer the American people a diverse COVID-19 vaccine portfolio and underscores the importance of Novavax' partnership with the U.S. government to ensure continuous access to a protein-based option as part of public health measures," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We look forward to continuing our collaboration with the U.S. government on the development of our COVID-19 vaccine to meet the requirements of the FDA and our commercial customers for the upcoming 2023/2024 vaccination campaign."

This contract will support the U.S. government's continued efforts to make Novavax' protein-based vaccine available for free to states, jurisdictions, federal pharmacy partners and federally qualified health centers.

The Novavax COVID-19 Vaccine, Adjuvanted received emergency use authorization from the U.S. FDA for use to prevent COVID-19 in adults aged 18 and older and in adolescents aged 12 through 17 as a primary series, and as a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals aged 18 and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals aged 18 and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

This contract is supported with previously allocated federal funds from HHS, the Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority, through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract Number W15QKN-16-9-1002, Project Number MCDC2011-001.

Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been approved or licensed by the U.S. FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) as a primary series in individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. 

Authorized Use
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) 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 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

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 to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Novavax COVID-19 Vaccine, Adjuvanted. Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines.

Myocarditis and Pericarditis: Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of the Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Information). The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#myocarditis-pericarditis).

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
Adverse reactions reported in clinical trials following administration of the Novavax COVID-19 Vaccine, Adjuvanted include injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, fever, chills, injection site pruritus, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and pericarditis.

Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Novavax COVID-19 Vaccine, Adjuvanted.

Reporting Adverse Events and Vaccine Administration Errors
The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):

• vaccine administration errors whether or not associated with an adverse event,
• serious adverse events (irrespective of attribution to vaccination),
• cases of myocarditis,
• cases of pericarditis,
• cases of Multisystem Inflammatory Syndrome (MIS), in adults and children, and
• cases of COVID-19 that results in hospitalization or death.

Complete and submit reports to VAERS online: For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

To the extent feasible, report adverse events to Novavax, Inc. using the following contact information or by providing a copy of the VAERS form to Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).

Please click to see the Novavax COVID-19 Vaccine, Adjuvanted Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and EUA Full Prescribing Information.

Please click to see the Fact Sheet for Recipients and Caregivers.

About NVX-CoV2373 (Novavax' COVID-19 Vaccine, Adjuvanted)
The Novavax COVID-19 Vaccine, Adjuvanted is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The vaccine contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization, and distribution of its vaccine worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.