Sputnik V Vaccine Highly Effective After All, Peer-Reviewed Data Suggest

Peer-reviewed interim results from the Gamaleya Research Institute’s phase 3 vaccine trial showed that its Sputnik V vaccine was safe and nearly 92 percent effective against symptomatic coronavirus, encouraging results that line up with previous data released by Moscow researchers.

The interim results, which have just been published in The Lancet, showed that a two-dose regimen of the recombinant adenovirus-based vaccine was 91.6 percent effective against symptomatic COVID-19 based on data from 19,866 participants placed in either the vaccine cohort (16,501 patients) or the placebo group (5,476 patients). The vaccine was also found, remarkably, to be 91.8 percent effective in patients older than 60 years. The vaccine’s peer-reviewed efficacy rates show it to be competitive with Pfizer/BioNTech’s and Moderna’s vaccines.

Serious adverse events were noted in 68 participants — 45 in the vaccine group and 23 in the placebo group — but they were deemed unrelated to COVID-19. And four deaths were recorded during the trial, but none were considered vaccine-related.

The high efficacy numbers line up with previous results claimed from the phase 3 trial, though the data had not been peer-reviewed and available to the public until now. In December, the institute announced 91.4 percent efficacy for the double-dose shot and a month earlier unveiled an interim analysis that demonstrated 92 percent efficacy.

Vaccine experts had criticized Russia for authorizing and administering Sputnik V before the late-stage trial had begun, and more was known about its safety and efficacy. But Julian Tang, a consultant virologist at the Leicester Royal Infirmary, said the peer-reviewed findings validate the Kremlin’s controversial actions to a degree.

“Despite the earlier misgivings about the way this Russian Sputnik V vaccine was rolled out more widely — ahead of sufficient phase 3 trial data — this approach has been justified to some extent now,” Tang said. “We should be more careful about being overly critical about other countries’ vaccine designs [and] programs.”

Cecil Czerkinsky, research director of France’s National Institute of Health and Medical Research, called the peer-reviewed results “fairly impressive” and noted the double-dose vaccine’s relative ease of manufacturing and deployment. Unlike the Pfizer/BioNTech and Moderna vaccines, Sputnik V can be stored at normal refrigerator temperatures of 35.6 to 46.4 degrees Fahrenheit.

“This vaccine appears to be highly efficacious and immunogenic across age groups. This is clearly good news,” he said.

Read the interim results here: bit.ly/39FckRb. — James Miessler