COVID-19 Vaccine, Adjuvanted

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 COVID-19 vaccine, adjuvanted 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 approved an Emergency Use Authorization (EUA) for the COVID-19 vaccine, Adjuvanted to allow use in individuals 12 years of age and older to prevent COVID-19 disease caused by SARS-CoV-2 infection.

Talk to your doctor about the risks and benefits of receiving this vaccine.

COVID-19 disease is caused by an infection with a coronavirus called SARS-CoV-2. 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.

The COVID-19 vaccine, adjuvanted will be given to you as an injection into the muscle. The COVID-19 vaccine , adjuvanted is given as a two doses given 3 to 8 weeks apart in individuals who have not previously been vaccinated with COVID-19.

The FDA has also approved an EUA for the COVID-19 vaccine, adjuvanted to allow a booster dose of the most recent formulation for people 12 years or older to be given at least 2 months after receipt of any other COVID-19 vaccine.

The FDA has also approved an EUA for the COVID-19 vaccine, adjuvanted to be given as an additional dose in individuals with altered immune system due to medical conditions or other drugs, at the discretion of their healthcare provider.

There are many variants of the COVID-19 virus and the vaccine will need to be reformulated periodically to cover the current circulating variants.

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.
• are breastfeeding.
• 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.

In an ongoing clinical trial, the COVID-19 vaccine, adjuvanted has been shown to prevent COVID-19 after the two-dose series. How long you are protected against COVID-19 is currently unknown.

Side effects that have been reported with the COVID-19 vaccine, adjuvanted 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 COVID-19 vaccine, adjuvanted 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 COVID-19 vaccine, adjuvanted.

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

Myocarditis and pericarditis have occurred in some people who have received the COVID-19 vaccine, adjuvanted. 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:

• chest pain
• shortness of breath
• feelings of having a fast-beating, fluttering, or pounding heart

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

• 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 1-844-668-2829 or 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: https://www.cdc.gov/vsafe.

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

When you get your dose, you will get a vaccination card. Remember to bring your card when you return for additional doses.

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.

• Ask the vaccination provider.
• Visit CDC at https://bit.ly/3vyvtNB.
• Visit FDA at https://bit.ly/3qI0njF.
• Contact your local or state public health department.

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).

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.

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.

• NVX-CoV2373
• Novavax COVID-19 vaccine