The Novavax COVID-19 Vaccine, Adjuvanted is authorized by the FDA for use under an Emergency Use Authorization (EUA) for active immunization to prevent COVID-19 in individuals 12 years of age and older, as a two-dose primary series. It is also available as a booster dose for specific individuals.

This vaccine will not treat an active COVID-19 infection. Like any vaccine, Novavax COVID-19 Vaccine, Adjuvanted may not provide protection in every person. Novavax COVID-19 Vaccine is given as an intramuscular injection.

In Europe Novavax COVID-19 Vaccine has the trade name Nuvaxovid and in India it has the trade name Covovax. During development it went under the name NVX-CoV2373. It does not have a trade name in the US as it is an unapproved vaccine, it is referred to as Novavax COVID-19 Vaccine, Adjuvanted or sometimes Covid-19 Vaccine Novavax.

What is COVID-19?

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

Can the Novavax COVID-19 Vaccine give me COVID-19?

No. This vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

The Novavax COVID-19 Vaccine is given by injection in the muscle.

Primary series:

Two-dose primary series given three weeks apart, for individuals 16 years and older.

Booster dose:

A booster dose for individuals 18 years of age and older, given at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine:

-for individuals that a FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and

-for individuals who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

Are there other vaccines available for preventing COVID-19?

Comirnaty (COVID-19 Vaccine, mRNA) and Spikevax (COVID-19 Vaccine, mRNA) are FDA-approved COVID-19 vaccines. Other vaccines to prevent COVID-19 may be available under EUA.

You should not get the Novavax COVID-19 Vaccine, Adjuvanted if you:

• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine

What should I tell my doctor before receiving Novavax COVID-19 Vaccine?

Tell your vaccination provider about all of your medical conditions, including if you:

• 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

There is a remote chance that this medicine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination.

Signs of a severe allergic reaction can include:

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

If you experience a severe allergic reaction and you are no longer at your place of vaccination, call 9-1-1, or go to the nearest hospital.

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 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 this medicine 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 in countries outside of the United States with this medicine include:

• Severe allergic reactions
• Myocarditis (inflammation of the heart muscle)
• Pericarditis (inflammation of the lining outside the heart)

These may not be all the possible side effects of this vaccine. Serious and unexpected side effects may occur. The Novavax COVID-19 Vaccine, Adjuvanted is still being studied in clinical trials.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you 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 EUA” in the first line of box #18 of the report form.

Before receiving Novavax COVID-19 Vaccine, tell your vaccination provider about all other vaccines you have received and all medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products.
Data have not yet been submitted to FDA on administration of the Novavax COVID-19 Vaccine, Adjuvanted at the same time as other vaccines. If you are considering receiving the Novavax COVID-19 Vaccine, Adjuvanted with other vaccines, discuss your options with your healthcare provider.