NOVA VAX INGREDIENTS FREE
The Novavax COVID-19 Vaccine, Adjuvanted is a colorless to slightly yellow, clear to mildly opalescent suspension, free from visible particles.
NOVA VAX INGREDIENTS 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.Ī 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. Discard the vial 6 hours after the first puncture. Storage After First Puncture of the Vaccine VialĪfter the first needle puncture, hold the vial between 2° to 25☌ (36° to 77☏) for up to 6 hours.
Store the unpunctured multi-dose vial in a refrigerator between 2° to 8☌ (36° to 46☏). DOSAGE AND ADMINISTRATION Storage and Handling 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. Symptoms may appear 2 to 14 days after exposure to the virus. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. It is predominantly a respiratory illness that can affect other organs. ġ 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-19Ĭoronavirus 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. įor information on clinical trials that are testing the use of the Novavax COVID-19 Vaccine, Adjuvanted for active immunization against COVID-19, please see. For the most recent Fact Sheet, please see. See this Fact Sheet for instructions for preparation and administration. 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 bivalent 1 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.įor 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. The primary series of the Novavax COVID-19 Vaccine, Adjuvanted is two doses (0.5 mL each) given 3 weeks apart. 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 Novavax COVID-19 Vaccine, Adjuvanted is a suspension for intramuscular injection. See “ MANDATORY REQUIREMENTS FOR THE NOVAVAX COVID-19 VACCINE, ADJUVANTED ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements. 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. SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS 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.
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