Gamaleya Sputnik V COVID-19 Vaccine

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