Bharat Covaxin

by Editorial Board last updated 2021-12-23 10:27:18.856472-05:00 © Antimicrobial Therapy, Inc.
BBV152

Administration

Vaccine

  • Bharat COVID-19 Vaccine.  Covaxin, BBV152

Authorized for Use in

  • WHO EUL, India. Meets US entry requirements.

Age

  • >18 years

Type

  • Inactivated whole virion.

Primary Dosing

  • 2 doses (0.5 mL IM) spaced by 4 weeks. 
  • Moderate and severe immunocompromise:  additional primary dose (dose 3) 1-3 months after dose 2
  • Three doses of mRNA vaccine is the only current effective strategy against the Omicron variant

Booster Dosing

  • No recommendation

Interchangeability

  • Immunogencity increased with mRNA vaccine for dose 2 compared to Bharat for dose 2.

Storage

  • 2-8°C (36-46°F)

Efficacy

Overall against symptomatic disease

  • 78% in Phase 3 trials pre-delta

Real world against hospitalization

  • No data

Age > 60 years

  • 68% in Phase 3 trials pre-delta (limited subject numbers)

Pediatric

  • Not authorized

Against severe disease / death

  • 93%

Against asymptomatic infection / transmission

  • 63% against asymptomatic infection

Duration of efficacy after final dose

  • No data

Toxicities

Contraindications

  • Anaphylaxis to any vaccine component or a previous dose of Bharat vaccine.

Precautions

  • No data

Not contraindications

  • A history of anaphylaxis to any other vaccine or injectable therapy (i.e. intramuscular, intravenous, or subcutaneous vaccines or therapies) is not a contraindication to vaccination

Adverse effects

  • Rare anaphylaxis.  Local and mild systemic reactions

Special Needs Populations

Pregnancy

  • Recommended for use in pregnancy.  No adverse outcomes in trials or post-marketing surveillance

Immunocompromised / HIV

  • Moderate and severe immunocompromise:  additional primary dose (dose 3) 1-3 months after dose 2.  Not needed for controlled HIV patients