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ANTIINFECTIVES FOR SYSTEMIC USE › VACCINES › VIRAL VACCINES › Covid-19 vaccines
covid-19, inactivated virus
J07BN03
Forms & Strengths
- Suspension for intramuscular injection, 0.5 mL per dose
- Single-dose pre-filled syringes or multidose vials containing 3 µg to 5 µg of inactivated SARS-CoV-2 antigen per 0.5 mL
Adult Dosing
- Primary series: 0.5 mL intramuscularly administered as two doses spaced 21 to 28 days apart
- Booster doses: 0.5 mL intramuscularly administered at least 3 to 6 months after completion of the primary series, per current public health guidelines
Pediatric Dosing
- Children and adolescents (age varies by specific vaccine authorization, typically 3 to 18 years): 0.5 mL intramuscularly administered as two primary doses spaced 21 to 28 days apart
- Booster doses in eligible pediatric populations per regional immunization guidelines
Indications
- Active immunization for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals meeting the authorized age threshold
Mechanism of Action
- Contains whole SARS-CoV-2 virus inactivated via chemical methods (e.g., beta-propiolactone)
- Stimulates humoral and cellular immune responses against multiple viral structural proteins, including the spike and nucleoprotein antigens, inducing neutralizing antibody production and T-cell activation
Contraindications
- History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine
- History of severe allergic reaction to a previous dose of the same inactivated COVID-19 vaccine
Adverse Reactions
- Very common (>10%): Injection site pain, tenderness, fatigue, headache, myalgia, arthralgia
- Common (1-10%): Injection site redness, swelling, fever, chills, nausea
- Uncommon (0.1-1%): Lymphadenopathy, rash, vomiting, pruritus at injection site
- Rare (<0.1%): Severe allergic reactions including anaphylaxis, transient paresthesia
Drug Interactions
- Immunosuppressive therapies (e.g., chemotherapy, high-dose corticosteroids, biologic agents) may reduce the immune response to the vaccine
- Can be administered concomitantly with other inactivated or live vaccines at different injection sites, per immunization guidelines
Curated Content: Needs Vetting Before Put to Clinical Use