Novavax COVID-19 Vaccine

Administration

Vaccine

• Novavax COVID-19 Vaccine (Nuvaxovid, Covovax (India), NVX-CoV2373)

Authorized for Use in

• India, EU EMA, WHO EUL, Meets US Entry Requirements; US FDA EUA submission is expected by the end of 2021

Age

• ≥ 18 yrs

Type

• Recombinant protein subunit, adjuvanted

Primary Dosing

• 0.5 ml IM (5 ug)

Booster Dosing

• No recommendation at present

Interchangeability

• No manufacturer data available on the interchangeability of Nuvaxovid with other COVID-19 vaccines to complete the primary vaccination course.  In vitro Novavax vaccine shows boosts neutralizing response after primary series with Pfizer vaccine or AstraZeneca vaccine.

Storage

• 2-8°C (36-46°F) for up to 9 months; protect from light

Efficacy

Overall against symptomatic disease

• All adults: 90.4%, 7 days after dose 2; Age 18-64 yrs: 89.8%

Real world against hospitalization

• No real word experience at present

Age > 65 years

• 88.9%

Pediatric

• No data at present

Against severe disease / death

• Phase 3 trial: Adults: 100%, 7 days after dose 2

Against asymptomatic infection / transmission

• No data

Duration of efficacy after final dose

• No data

Toxicities

Contraindications

• Hypersensitivity to the active substance or to any vaccine ingredients

Precautions

• Awaiting FDA EUA

Adverse effects

• Local and systemic adverse reactions more frequently after Dose 2 than after Dose 1.  Increased by co-administration of influenza vaccine. Fatigue, myalgia, headache, malaise, each in approximately 50%

Special Needs Populations

Pregnancy

• Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, parturition, or post-natal development. Use if benefits outweight risk.

Immunocompromised / HIV

• No data