• Novavax's updated COVID-19 vaccine is now available at a wide range of retailers, including Costco, CVS Pharmacy, Giant, Publix, Rite Aid, Stop & Shop and Topco
  • Novavax's vaccine is the only protein-based non-mRNA COVID-19 vaccine option in the U.S.
  • Novavax's vaccine finder is available at us.novavaxcovidvaccine.com

GAITHERSBURG, Md., Oct. 13, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has finalized agreements with major pharmacy retailers and prominent Group Purchasing Organizations (GPO) in the U.S. to provide the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) to prevent COVID-19 in individuals aged 12 and older this vaccination season.

Through these agreements Novavax's updated COVID-19 vaccine will be widely available across the U.S., including but not limited to, Costco, CVS Pharmacy, Giant, Publix, Rite Aid, Stop & Shop and Topco, a large retail purchaser for member pharmacies. Novavax's vaccine received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on October 3, 2023.

"We are committed to ensuring immediate nationwide availability of our protein-based non-mRNA vaccine, and our agreements with leading U.S. pharmacy retailers will ensure people have options to help protect themselves and their loved ones against COVID-19 this fall," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Individuals will have access to our protein-based vaccine through major pharmacies, clinics, physicians' offices and government programs."

In addition to retail pharmacies, physicians' offices and public health clinics, Novavax's vaccine will be available through various government entities such as Vaccines for Children, Federal Qualified Health Centers, Indian Health Services and the U.S. Department of Defense. In addition, Novavax has donated product to "Bridge Access Program For COVID Vaccines and Treatments" to provide access for adults in the U.S. without other sources of coverage.

Novavax continues to work with additional retailers and anticipates that the network of partners providing its updated COVID-19 vaccine will continue to grow. The Company will also ensure its vaccine is available through GPO agreements, including Vizient, Inc., Premier and Healthtrust Purchasing Group, which provide broad access to the U.S. health system landscape.

Doses of Novavax's vaccine can be located on us.novavaxcovidvaccine.com or vaccines.gov.

AUTHORIZED USE IN THE U.S.
Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.

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.

IMPORTANT SAFETY INFORMATION
What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
Tell your vaccination provider about all of your or your child's medical conditions, including if you or your child:

  • have any allergies
  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects your immune system
  • are pregnant or plan to become pregnant
  • are breastfeeding
  • have received another COVID-19 vaccine
  • have ever fainted in association with an injection

Who should not get the Novavax COVID-19 Vaccine, Adjuvanted?
A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:

  • a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
  • a severe allergic reaction to any ingredient of these vaccines

What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?
There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose. For this reason, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

  • Difficulty breathing
  • Swelling of the face and throat
  • A fast heartbeat
  • A bad rash all over your body
  • Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within 10 days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine:

  • Chest pain
  • Shortness of breath
  • Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported in clinical trials with the Novavax COVID-19 Vaccine, Adjuvanted include:

  • Myocarditis (inflammation of the heart muscle)
  • Pericarditis (inflammation of the lining outside the heart)
  • Injection site reactions: pain/tenderness, swelling, redness and itching
  • General side effects: fatigue or generally feeling unwell, muscle pain, headache, joint pain, nausea, vomiting, fever, chills
  • Allergic reactions such as hives and swelling of the face
  • Swollen lymph nodes

Side effects that have been reported in post-authorization use with the Novavax COVID-19 Vaccine, Adjuvanted include:

  • Severe allergic reactions
  • Myocarditis (inflammation of the heart muscle)
  • Pericarditis (inflammation of the lining outside the heart)
  • Paresthesia (unusual feeling in the skin such as tingling or a crawling feeling)
  • Hypoesthesia (decreased feeling or sensitivity, especially in the skin)

These may not be all the possible side effects. Serious and unexpected side effects may occur. The possible side effects are still being studied.

What should I do about side effects?
If you or your child experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider for any side effects that bother you or your child or do not go away.
Report vaccine side effects to the FDA and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1–800–822–7967 or report online to https://vaers.hhs.gov/reportevent.html . Please include "Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) EUA" in the first line of box #18 of the report form.
In addition, you can report side effects to Novavax, Inc., using the following contact information: Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).

What about pregnancy or breastfeeding?
If you or your child are pregnant or breastfeeding, discuss the options with your healthcare provider.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy. Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com .

Please see the Fact Sheet for Recipients and Caregivers for more information. Reporting Adverse Events and Vaccine Administration Errors

  • Adverse events can also be reported to Novavax, Inc. using the following contact information or by providing a copy of the VAERS form to Novavax, Inc. Website: https://www.novavaxmedinfo.com/, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).

About Nuvaxovid™ XBB.1.5 2023-2024 Formula (NVX-CoV2601)
NVX-CoV2601 is an updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the XBB.1.5 subvariant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID. 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° 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. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza and COVID-19 and influenza combined. Please visit novavax.com and LinkedIn for more information.

Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, including the availability of its updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) and the timing of delivery and distribution of its vaccine are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; manufacturing, distribution or export delays or challenges; challenges in obtaining commercial adoption of our updated protein-based non-mRNA XBB COVID-19 vaccine, NVX-CoV2373 or any COVID-19 variant strain-containing formulation; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:
Investors
Erika Schultz
240-268-2022
ir@novavax.com

Media
Ali Chartan
240-720-7804
media@novavax.com

 

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