Novavax Updated COVID-19 Vaccine Receives Emergency Use Authorization in Taiwan

Novavax, Inc, a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the Taiwan Food and Drug Administration has granted emergency use authorization for Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 in individuals aged 12 and older.

Doses of Novavax's updated vaccine will be delivered to Taiwan under an existing advanced purchase agreement and will be widely available at vaccination centers across Taiwan. More information is available from the Taiwan Centers for Disease Control.

"We are working closely with Taiwan's authorities to ensure doses of our updated protein-based non-mRNA COVID-19 vaccine are made available at vaccination centers across Taiwan as soon as possible," said John C. Jacobs, President and Chief Executive Officer, Novavax. "As we head into the holiday season with more time spent together and indoors, COVID-19 infection rates are likely to rise and our best line of defense is vaccination."

Authorization was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and induce a broad response against circulating variants.1,2

In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included 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 authorized in the U.S., the European Union, Canada and by the World Health Organization, and is under review in other markets.

Trade Name in the U.S.

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

NOVAVAX COVID-19 VACCINE AUTHORIZED USES

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?

Call the vaccination provider or your healthcare provider for any side effects that bother you or your child or do not go away.

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.

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.About Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601)

NVX-CoV2601 is an updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the Omicron 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 help 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.

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