Russia, Stelis Biopharma Team Up to Make 200 Million Doses of Sputnik V

The Russian Direct Investment Fund (RDIF) and Indian contract manufacturer Stelis Biopharma have partnered to produce 200 million doses of the Sputnik V COVID-19 vaccine.

Stelis said the partnership will “make a substantial contribution toward providing global supply” of the two-dose vaccine, with deliveries slated to begin in the third quarter. The pair didn’t disclose how doses will be allocated to countries.

The Serum Institute of India, the world’s largest vaccine maker, is mass producing AstraZeneca (AZ)’s COVID-19 vaccine and has pledged that 50 percent of doses will be reserved for domestic use. It’s possible that Stelis could commit to a similar arrangement for the Sputnik V vaccine for use in India if the country decides to authorize it.

RDIF has forged agreements with more than a dozen manufacturers in 10 countries to produce 1.4 billion doses of Sputnik V, a massive amount that could help vaccination efforts in countries struggling to obtain authorized vaccines. In the case of the EU, which is seeing significant delays for shipments of AZ’s vaccine, individual member states, including Hungary and Slovakia, have secured supplies of Sputnik V despite it still being under review by the European Medicines Agency (DID, March 11).

An adenovirus-based vaccine, Sputnik V has proven highly effective and has now been authorized in more than 50 countries, despite initial skepticism surrounding Russia’s authorization ahead of late-stage trials. The vaccine demonstrated a 91.6 percent efficacy against symptomatic COVID-19, according to its peer-reviewed phase 3 interim analysis published in The Lancet (DID, Feb. 3).

The global distribution efforts for Sputnik V have come under scrutiny by European Commission President Ursula von der Leyen, who wondered “why, theoretically, [Russia is] offering millions and millions of doses while not sufficiently progressing” in vaccinating its own population. The country has vaccinated just 3.5 million of its 144 million population with both shots of the vaccine. — James Miessler