Gamaleya Sputnik V COVID-19 Vaccine

Gam-COVID-Vac, Gamaleya Research Institute

Administration

Vaccine

  • Gamaleya COVID-19 Vaccine. Sputnik V, Gam-Covid-Vac.

Authorized for Use in

  • Russia. EMA application under review.  The approval process of the Gamaleya vaccine has been delayed by WHO and EMA due to a lack of adequate data and WHO concerns about the manufacturing process not meeting standards. Data are still being reviewed. Seed strain uncharacterized.
  • Does not meet US Entry requirements

Age

  • ≥ 18 yrs

Type

  • Nonreplicating live adenovirus

Primary Dosing

  • 2 doses 21 days apart.
  • Dose 1 is Ad26, Dose 2 Ad5
  • Three doses of mRNA vaccine is the only current effective strategy against the Omicron variant

Booster Dosing

  • No recommendation

Interchangeability

  • No data

Storage

  • -18°C (0°F) for up to 6 mos; 2-8°C (36-46°F) for up to 30 days

Efficacy

Overall against symptomatic disease

  • 91.6% in 1 published but highly criticized study.  Data from a reported trial in Argentina (n = 40,387) of a single dose of a preparation called Sputnik Light showed an efficacy of 78.6% against symptomatic infection; 87.6% against hospitalization, and 84.7% against death.

Real world against hospitalization

  • No data

Age > 65 years

  • 92% in age > 60 yrs

Pediatric

  • Not approved

Against severe disease / death

  • 100% (preliminary)

Against asymptomatic infection / transmission

  • No data

Duration of efficacy after final dose

  • No data

Toxicities

Contraindications

  • No data

Precautions

  • No data

Not contraindications

  • No data

Adverse effects

  • No data

Special Needs Populations

Pregnancy

  • No data

Immunocompromised / HIV

  • No data