Novavax's updated protein-based COVID-19 vaccine is now an option for all 194 World Health Organization member states

Novavax, Inc, a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the World Health Organization (WHO) has received an Emergency Use Listing (EUL) for the COVID-19 vaccine Nuvaxovid™ XBB.1.5 (NVX-CoV2601) for active immunization to prevent COVID-19 in individuals 12 years of age and older. The EUL supports WHO Member States in assessing vaccines with the aim of accelerating availability and enables WHO's 194 Member States to expedite regulatory approvals for the import and administration of the vaccine.

“Receiving emergency use authorization from WHO for our updated non-mRNA protein-based COVID-19 vaccine enables accelerated regulatory approvals for its 194 Member States and UN procurement agencies, such as UNICEF, supporting equitable access to our vaccine around the world " said John C. Jacobs , President and Chief Executive Officer of Novavax . "Rural or hard-to-reach areas can benefit from our vaccine's easy transportation and storage profile. As part of a diversified vaccine portfolio, our vaccine can play an important role in getting people up to speed "To protect the entire world from the latest variants."

Novavax's vaccine can be stored at 2 to 8 degrees Celsius and has a 12-month shelf life, simplifying delivery, reducing carbon footprint and reducing waste. 1-4

The EUL was based on non-clinical data demonstrating that Novavax's COVID-19 vaccine induces functional immune responses against the XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data showed that Novavax's vaccine produced neutralizing antibody responses to the BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 subvariants, as well as CD4+ polyfunctional cellular (T cell) responses against EG. 5.1 and XBB.1.16.6. These data suggest that Novavax's vaccine can stimulate both mechanisms of the immune system and produce a broad response to variants currently circulating. 5.6

In clinical trials, the most common side effects of Novavax's COVID-19 prototype vaccine (NVX-CoV2373) were headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.

Novavax's updated COVID-19 vaccine is also approved in the United States and European Union and is being evaluated in other markets.

Trade name in the USA

The trade name Nuvaxovid™ has not been approved by the US Food and Drug Administration (FDA). 

APPROVED USES OF NOVAVAX'S ADJUVANTED COVID-19 VACCINE (FORMULA 2023-2024)

Novavax's adjuvanted COVID-19 vaccine (Formula 2023-2024) has not been approved or licensed by the FDA but is under an FDA Emergency Use Authorization ( Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (COVID-19) for use in people 12 years of age and older. For information about the Novavax adjuvanted COVID-19 vaccine, see the full fact sheet.

Emergency use of this device is authorized only for the duration of the declaration as long as circumstances exist that justify authorization of emergency use of the medical device pursuant to Section 564(b)(1) of the FD&C Act. Unless the declaration is revoked earlier or the approval is revoked.

IMPORTANT SAFETY INFORMATION

What should you tell your vaccinator before you or your child receives the Novavax adjuvanted COVID-19 vaccine?

Tell your vaccinator about any medical conditions you or your child have, including if you or your child:

have allergies

Have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the heart sac).

have fever

have a blood clotting disorder or are taking medicines to prevent blood clots

have an immune deficiency or are taking medications that weaken your immune system

Are pregnant or planning to become pregnant

Breastfeeding

have received another COVID-19 vaccine

Vaccination-related fainting

Who Should Not Receive Novavax's Adjuvanted COVID-19 Vaccine ?  

A person should not receive Novavax's adjuvanted COVID-19 vaccine if they:

had a severe allergic reaction after a previous dose of adjuvanted Novavax COVID-19 vaccine

had a severe allergic reaction to any of the ingredients in these vaccines

What are the risks of Novavax's adjuvanted COVID-19 vaccine?  

There is a small chance that the vaccine could cause a serious allergic reaction. A serious allergic reaction would normally occur within a few minutes to an hour after administration. For this reason, the vaccinator may ask you or your child to wait for monitoring at the place where you or your child were vaccinated after vaccination. Signs of a serious allergic reaction include:

Difficulty breathing

Swelling of the face and throat

heart racing

Severe rash all over the body

Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the sac around the heart) have occurred in some people who received the vaccine. Most of these people experienced symptoms within 10 days of vaccination. The chances of this happening are very low. You should seek immediate medical attention if you or your child have any of the following symptoms after vaccination:

Chest pain

Shortness of breath

The feeling that your heart is racing, fluttering, or beating violently

Side effects reported in clinical trials of Novavax's adjuvanted COVID-19 vaccine include:

Myocarditis (inflammation of the heart muscle)

Pericarditis (inflammation of the sac around the heart)

Reactions at the injection site: pain/tenderness, swelling, redness and itching

General side effects: tiredness or general malaise, muscle pain, headache, joint pain, nausea, vomiting, fever, chills

Allergic reactions such as hives and facial swelling

Swollen lymph nodes

Side effects reported following approval of Novavax's adjuvanted COVID-19 vaccine include:

Severe allergic reactions

Myocarditis (inflammation of the heart muscle)

Pericarditis (inflammation of the sac around the heart)

Paresthesia (unusual feeling on the skin, such as tingling or crawling)

Hypesthesia (decreased feeling or sensitivity, especially of the skin)

These may not be all side effects. Serious and unexpected side effects may occur. The possible side effects continue to be investigated.

What should I do if I have side effects?  

If you or your child experiences a severe allergic reaction, call 911 or go to the nearest hospital.

Call the vaccinator or your healthcare provider if you or your child have significant side effects or if they do not go away.

What about pregnancy and breastfeeding?

If you or your child are pregnant or breastfeeding, ask your healthcare provider for advice.

There is a Pregnancy Exposure Registry monitoring the pregnancy outcomes of women exposed to Novavax's adjuvanted COVID-19 vaccine during pregnancy. 

Further information can be found in the information sheet for vaccinated people and carers . Reporting side effects and errors during vaccination

About Nuvaxovid 

™ It is a protein-based vaccine made by making copies of the surface spike protein of the SARS-CoV-2 that causes COVID-19. Thanks to Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as an antigen to prime the immune system to recognize the virus, while Novavax's Matrix-M™ adjuvant enhances and expands the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2°C to 8°C, allowing existing vaccine supply and cold chains to be leveraged. 

About Matrix-M™ Adjuvant

Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system's response when added to vaccines, making them broader and more long-lasting. The Matrix-M adjuvant stimulates the migration of antigen-presenting cells at the injection site and improves antigen presentation to the surrounding lymph nodes. 

About Novavax

Novavax, Inc. promotes better health through the discovery, development and commercialization of innovative vaccines to protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Maryland , USA, 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. Novavax is focused on the world's most pressing health issues and is currently testing vaccines against COVID-19, influenza and a combination of COVID-19 and influenza.

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