The Novavax coronavirus disease 2019 (COVID-19) vaccine is currently being studied to prevent coronavirus disease 2019 caused by the SARS-CoV-2 virus.
Information from clinical trials is available at this time to support the use of Novavax COVID-19 vaccine to prevent COVID-19.
Novavax COVID-19 vaccine has not undergone the standard review to be approved by the FDA for use. However, the FDA has also approved an EUA for the Novavax COVID-19 vaccine to allow a two dose primary series
and as a first booster dose for certain people 18 years and older.
Talk to your doctor about the risks and benefits of receiving this medication.
Novavax COVID-19 vaccine may cause a severe allergic reaction. Symptoms of allergic reaction can include difficulty breathing, face or throat swelling, fast heartbeat, rash, dizziness and weakness. If any of these symptoms should occur, seek immediate medical attention. Myocarditis and pericarditis have occurred in some people who have received the vaccine.Symptoms of myocarditis and pericarditis can include chest pain, shortness of breath, or feeling of fast heartbeat or fluttering or pounding heart. If any of these symptoms should occur, seek immediate medical attention.
What is COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory (lung) illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever, chills, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea.
How is the Novavax COVID-19 vaccine given?
The Novavax COVID-19 vaccine will be given to you as an injection into the muscle. The Novavax COVID-19 vaccine vaccination is given as a two doses given 3 weeks apart.
The FDA has also approved an EUA for the Novavax COVID-19 vaccine to allow a first booster dose for individuals 18 years or older who are unable to receive a FDA-authorized mRNA bivalent booster or who choose to receive the Novavax COVID-19 vaccine booster as they otherwise would not receive a booster.
What should you tell the person who is giving the vaccine?Tell your vaccine 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 of the heart)
have a fever
have a bleeding disorder or are on a blood thinner such as warfarin (Coumadin, Jantoven).
are immunocompromised (weakened immune system) or are on a medicine that affects your immune system.
are pregnant or plan to become pregnant.
have received another COVID-19 vaccine.
have ever fainted in association with an injection.
have had a serious allergic reaction to any ingredient in this vaccine.
What are the benefits of the Novavax COVID-19 vaccine?
In an ongoing clinical trial, the Novavax COVID-19 vaccine has been shown to prevent COVID-19 after the two-dose series. How long you are protected against COVID-19 is currently unknown.
What are the risks of the Novavax COVID-19 vaccine?
Side effects that have been reported with the Novavax COVID-19 vaccine include:
injection site pain, swelling, and redness
headache, feeling very tired, muscle aches, nausea, and fever
swollen lymph nodes
There is a remote chance that the Novavax COVID-19 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 of the Novavax COVID-19 vaccine.
Signs of a severe allergic reaction can include:
swelling of your face and throat
a fast heartbeat
a bad rash all over your body
dizziness and weakness
Myocarditis and pericarditis have occurred in some people who have received the Novavax COVID-19 vaccine. In most of these people, symptoms began within 10 days after getting the vaccine. 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:
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
These may not be all the possible side effects of the Novavax COVID-19 vaccine. Serious and unexpected side effects may occur. Novavax COVID-19 vaccine is still being studied in clinical trials.
What should I do about side effects?
If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital.
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 FDA/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 EUA" in the first line of box #18 of the report form.
In addition, you can report side effects to Novavax, Inc. at
1-844-668-2829or http://www.novavaxmedinfo.com .
You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: http://www.cdc.gov/vsafe .
Will the Novavax vaccine give me COVID-19?
No. TheNovavax COVID-19 vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.
Keep your vaccination card
When you get your dose, you will get a vaccination card. Remember to bring your card when you return for additional doses.
Where will my vaccination information be recorded?
The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. For more information about IISs, visit: https://www.cdc.gov/vaccines/programs/iis/about.html.
Can I be charged an administration fee for receiving the COVID-19 vaccine?
No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).
Where can I report cases of suspected fraud?
Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.
What is the Countermeasures Injury Compensation Program?
The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one year from the date of receiving the vaccine. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427.The American Society of Health-System Pharmacists, Inc. represents that this information about the Novavax COVID-19 vaccine was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that the Novavax COVID-19 vaccine is not an approved vaccine for coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, is being investigated for and is currently available under an FDA emergency use authorization (EUA) to prevent COVID-19 in certain adults. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information, and specifically disclaims all such warranties. Readers of the information about the Novavax COVID-19 vaccine are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of this information. Readers are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information contained in this information is provided for informational purposes only. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. This information about the Novavax COVID-19 vaccine is not to be considered individual patient advice. Because of the changing nature of drug information, you are advised to consult with your physician or pharmacist about specific clinical use of any and all medications.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
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Selected Revisions: December 15, 2022.