Indications for: SPIKEVAX
Active immunization to prevent COVID-19 in individuals ≥18yrs of age.
The approval was based on data from the ongoing randomized, placebo-controlled, observer-blind phase 3 clinical trial which evaluated the efficacy, safety, and immunogenicity of Spikevax in adults 18 years of age and older in the US. The study excluded patients who were immunocompromised and with a known history of SARS-CoV-2 infection. A total of 30,415 patients were randomly assigned equally to receive 2 doses of Spikevax or saline placebo 1 month apart.
Efficacy Against COVID-19
Spikevax was 93.2% (95% CI, 91.0-94.8) effective at preventing COVID-19 in participants 18 years of age and older starting 14 days after the second dose. There were 55 cases of COVID-19 in the Spikevax group and 744 cases in the placebo group.
Spikevax was 98.2% (95% CI, 92.8-99.6) effective at preventing severe disease. There were 2 cases of severe COVID-19 in the Spikevax group and 106 cases in the placebo group.
Give by IM inj only. ≥18yrs: 0.5mL given as a 2-dose series 1 month apart.
<18yrs: not established.
Have epinephrine inj available. Increased risks of myocarditis and pericarditis (esp. within 7 days after the second dose); higher risk among males <40yrs of age, and highest among males 18–24yrs of age. Syncope. Immunocompromised. Pregnancy. Nursing mothers.
Immunosuppressants: may get suboptimal response.
Inj site reactions (eg, pain, swelling, tenderness, erythema), fatigue, headache, muscle pain, chills, joint pain, fever, nausea/vomiting.
To enroll in the pregnancy exposure registry, call (866) 663-3762.
Generic Drug Availability:
Multiple-dose vials (5.5mL, 7.5mL)—10