The Lancet publishes Phrase 3 data on Russian Sputnik V COVID-19 vaccine
Russia’s Sputnik V COVID-19 vaccine (Gam-COVID-Vac) has been confirmed as safe and effective following the presentation of data from the Phase 3 study.
The data
According to the data presented the Phase 3 study took place at 25 sites in Moscow and between 7th September 2020 and 24th November 2020 21,977 eligible adult participants were recruited.
The participants were randomised to two groups: placebo (5,476) and vaccine (16,501). The analysis presented included data from participants both groups who received at least one dose and continued in the study.
Effectiveness of Sputnik V at preventing COVID-19 was shown to be 91.6% at 21 days after administration of the first dose. There were 6 (0.1%) confirmed cases of COVID-19 in the vaccinated group and 62 cases (1.3%) in the placebo group.
According to preliminary data, the effectiveness of the vaccine against moderate to severe COVID-19 was 100%. From 15 to 21 days after the first dose, the efficacy was 73.6%, but 21 days after the first dose, no cases of moderate or severe disease were reported.
The effectiveness of the vaccine in the age group of participants over 60 years old did not differ significantly from that of participants aged 18-60 years. The average age of the elderly subgroup was 65.7 years, with a maximum of 87 years.
Safety and tolerability
The majority of participants tolerated the vaccine well. General safety and adverse events were analysed based on data from 12,296 participants who received both doses. The most common adverse events were flu-like illness, injection site reactions, headache, and weakness.
Analysis of serious adverse events included 21,862 participants who received at least one dose. There were 70 episodes of serious adverse events reported in 68 participants: 45 (0.3%) of the 16,427 participants in the vaccine group and 23 (0.4%) of the 5435 participants in the placebo group. The Independent Data Monitoring Committee (IDMC) confirmed that none of the serious side effects were associated with vaccinations. Full data on side effects will be presented in the following publications.
During the study, four deaths were reported: three in the vaccination group and one in the placebo group. None of the cases were related to vaccination.
Notes on the data
It should be noted that the interim analysis is limited by the incomplete amount of data and the age sample of study participants. The monitoring of the occurrence of rare adverse events is closely monitored by the Federal Service for Surveillance in Healthcare. Studies are also ongoing to evaluate a single dose regimen of the vaccine, which it appears could be highly effective.
Roll out of Sputnik V
More than a dozen countries, along with Russia, are using or plan to use Sputnik V in their mass vaccination programmes. According to TASS, the first shipment of the Russian vaccine arrived in Hungary on February 2. Hungarian Foreign Minister Peter Siyjarto indicated that "centralized procurement of vaccines by Brussels failed" which led to Hungary to look for "new sources of supply." Thus, Hungary became the first EU country to purchase the Russian vaccine.
The Russian Direct Investment Fund has applied for registration of the Sputnik V vaccine in the European Union. The Bundestag announced their readiness to cooperate in the production of the Russian vaccine, subject to obtaining a Sputnik V permit from the EMA.
