NOVAVAX COVID-19 Vaccine, Adjuvanted: Package Insert and Label Information

NOVAVAX COVID-19 VACCINE, ADJUVANTED- sars-cov-2 spike glycoprotein vaccine antigen nvx-cov2373 injection, suspension
Novavax, Inc.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Novavax COVID-19 Vaccine, Adjuvanted, for active immunization to prevent COVID-19 in individuals 12 years of age and older.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of the Novavax COVID-19 Vaccine, Adjuvanted. See “MANDATORY REQUIREMENTS FOR THE NOVAVAX COVID-19 VACCINE, ADJUVANTED ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements.

The Novavax COVID-19 Vaccine, Adjuvanted is a suspension for intramuscular injection.

Primary Series

The Novavax COVID-19 Vaccine, Adjuvanted is authorized for emergency use to provide a two-dose primary series to individuals 12 years of age and older. The primary series of the Novavax COVID-19 Vaccine, Adjuvanted is two doses (0.5 mL each) given 3 weeks apart.

Booster Dose

The Novavax COVID-19 Vaccine, Adjuvanted is authorized for emergency use to provide a first booster dose to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent¹ COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

For these individuals, a booster dose (0.5 mL) of Novavax COVID-19 Vaccine, Adjuvanted may be administered at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine.

See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see http://www.NovavaxCovidVaccine.com.

For information on clinical trials that are testing the use of the Novavax COVID-19 Vaccine, Adjuvanted for active immunization against COVID-19, please see http://www.clinicaltrials.gov.

¹ Authorized bivalent COVID-19 vaccines encode the spike protein of the Original SARS-CoV-2 and the Omicron BA.4/BA.5 SARS-CoV-2

DESCRIPTION OF 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), that appeared in late 2019. 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.

DOSAGE AND ADMINISTRATION

Storage and Handling

Storage of Unpunctured Vial

Store the unpunctured multi-dose vial in a refrigerator between 2° to 8°C (36° to 46°F).

Do not freeze.

Protect from light.

Storage After First Puncture of the Vaccine Vial

After the first needle puncture, hold the vial between 2° to 25°C (36° to 77°F) for up to 6 hours. Discard the vial 6 hours after the first puncture.

Dosing and Schedule

Primary Series

The Novavax COVID-19 Vaccine, Adjuvanted is administered intramuscularly as a primary series of two doses (0.5 mL each) 3 weeks apart in individuals 12 years of age and older.

Booster Dose

A first booster dose (0.5 mL) of Novavax COVID-19 Vaccine, Adjuvanted may be administered intramuscularly at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine in individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate and in individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

Dose Preparation

Inspect the vial

• The Novavax COVID-19 Vaccine, Adjuvanted is a colorless to slightly yellow, clear to mildly opalescent suspension, free from visible particles.
• Gently swirl the multi-dose vial before each dose withdrawal. Do not shake.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer the vaccine if either of these conditions exist.

Prepare for administration

• Record the date and time of the first puncture on the vial label.
• Novavax COVID-19 Vaccine, Adjuvanted is available in two presentations:
  • Multi-dose vial containing 5 doses of 0.5 mL each
  • Multi-dose vial containing 10 doses of 0.5 mL each
• Do not pool excess vaccine from multiple vials.
• After the first needle puncture, hold the vial between 2° to 25°C (36° to 77°F) for up to 6 hours.
• Discard vial 6 hours after the first puncture.

Administration

Administer the Novavax COVID-19 Vaccine, Adjuvanted intramuscularly.

CONTRAINDICATIONS

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Information).

WARNINGS

Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Novavax COVID-19 Vaccine, Adjuvanted.

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Myocarditis and Pericarditis

Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Information).

The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#myocarditis-pericarditis).

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.

Limitations of Vaccine Effectiveness

The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.

ADVERSE REACTIONS

Adverse Reactions in Clinical Trials

Adverse reactions reported in clinical trials following administration of the Novavax COVID-19 Vaccine, Adjuvanted include injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, fever, chills, injection site pruritus, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and pericarditis. (see Full EUA Prescribing Information).

Adverse Reactions Identified during Post-Authorization Use

Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Novavax COVID-19 Vaccine, Adjuvanted.

USE WITH OTHER VACCINES

There is no information on co-administration of the Novavax COVID-19 Vaccine, Adjuvanted with other vaccines.

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website http://www.NovavaxCovidVaccine.com to obtain the Fact Sheet) prior to the individual receiving each dose of the Novavax COVID-19 Vaccine, Adjuvanted, including:

• FDA has authorized the emergency use of the Novavax COVID-19 Vaccine, Adjuvanted, which is not an FDA-approved vaccine.
• The recipient or their caregiver has the option to accept or refuse the Novavax COVID-19 Vaccine, Adjuvanted.
• The significant known and potential risks and benefits of the Novavax COVID-19 Vaccine, Adjuvanted, and the extent to which such risks and benefits are unknown.
• Information about available alternative vaccines and the risks and benefits of those alternatives.

For information on clinical trials that are evaluating the use of the Novavax COVID-19 Vaccine, Adjuvanted to prevent COVID-19, please see www.clinicaltrials.gov.

Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of the Novavax COVID-19 Vaccine, Adjuvanted.

Provide the V-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. V-safe is a 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 second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information, visit: www.cdc.gov/vsafe.

MANDATORY REQUIREMENTS FOR THE NOVAVAX COVID-19 VACCINE, ADJUVANTED ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION

In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of the Novavax COVID-19 Vaccine, Adjuvanted, the following items are required. Use of the unapproved Novavax COVID-19 Vaccine, Adjuvanted for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met):

1. The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use in individuals 12 years of age and older.
2. The vaccination provider must communicate to the individual receiving the Novavax COVID-19 Vaccine, Adjuvanted or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving the Novavax COVID-19 Vaccine, Adjuvanted.
3. The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system.
4. The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
   • vaccine administration errors whether or not associated with an adverse event,
   • serious adverse events* (irrespective of attribution to vaccination),
   • cases of myocarditis,
   • cases of pericarditis,
   • cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and
   • cases of COVID-19 that result in hospitalization or death.
     Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Novavax COVID-19 Vaccine, Adjuvanted EUA” in the description section of the report.
5. The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of myocarditis, cases of pericarditis, cases of MIS in adults and children and cases of COVID-19 that result in hospitalization or death following administration of the Novavax COVID-19 Vaccine, Adjuvanted to recipients. *Serious adverse events are defined as:
   • Death;
   • A life-threatening adverse event;
   • Inpatient hospitalization or prolongation of existing hospitalization;
   • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
   • A congenital anomaly/birth defect;
   • An important medical event that based on appropriate medical judgment may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

OTHER ADVERSE EVENT REPORTING TO VAERS AND NOVAVAX, INC.

Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to Novavax, Inc. using the contact information below or by providing a copy of the VAERS form to Novavax, Inc.

Website	Fax number	Telephone number
www.NovavaxMedInfo.com	1-888-988-8809	1-844-NOVAVAX(1-844-668-2829)

ADDITIONAL INFORMATION

For general questions, visit the website or call the telephone number provided below.

To access the most recent Novavax COVID-19 Vaccine, Adjuvanted Fact Sheets, please scan the QR code or visit the website provided below.

Website	Telephone number
www.NovavaxCovidVaccine.com	1-844-NOVAVAX(1-844-668-2829)

AVAILABLE ALTERNATIVES

COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. There may be clinical trials or availability under EUA of other COVID-19 vaccines.

FEDERAL COVID-19 VACCINATION PROGRAM

This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. 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). For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html.

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.

AUTHORITY FOR ISSUANCE OF THE EUA

The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 Pandemic. In response, the FDA has issued an EUA for the unapproved product, Novavax COVID-19 Vaccine, Adjuvanted, for active immunization to prevent COVID-19 in individuals 12 years of age and older.

FDA issued this EUA based on Novavax, Inc.’s request and submitted data.

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Novavax COVID-19 Vaccine, Adjuvanted may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information.

This EUA for the Novavax COVID-19 Vaccine, Adjuvanted will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.

For additional information about EUA, visit FDA at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.