The Russian Sputnik V vaccine is 91.6% effective at preventing symptomatic COVID-19, according to preliminary results from a phase 3 trial, placing it in a similar league to the mRNA vaccines developed by Pfizer-BioNtech and Moderna, reports BusinessLIVE.
The publication is important because scientists have previously expressed concern about Russia’s decision to start wide-scale vaccination with Sputnik V before releasing phase 3 trial data for public scrutiny, and the haste with which more than a dozen other nations have approved the shot.
The report says the Russian government is among the potential vaccine suppliers that have held discussions with the Health Department, Health Minister Zweli Mkhize’s spokesperson Lwazi Manzi confirmed.
Study details
Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia
Denis Y Logunov, Inna V Dolzhikova, Dmitry V Shcheblyakov, Amir I Tukhvatulin, Olga V Zubkova, Alina S Dzharullaeva, Anna V Kovyrshina, Nadezhda L Lubenets, Daria M Grousova, Alina S Erokhova, Andrei G Botikov, Fatima M Izhaeva, Olga Popova, Tatiana A Ozharovskaya, Ilias B Esmagambetov, Irina A Favorskaya, Denis I Zrelkin, Daria V Voronina,Dmitry N Shcherbinin, Alexander S Semikhin, Yana V Simakova, Elizaveta A Tokarskaya, Daria A Egorova, Maksim M Shmarov, Natalia A Nikitenko, Vladimir A Gushchin, Elena A Smolyarchuk, Sergey K Zyryanov, Sergei V Borisevich, Boris S Naroditsky, Alexander L Gintsburg, Gam-COVID-Vac Vaccine Trial Group
Published in The Lancet on 2 February 2021
Abstract
Background
A heterologous recombinant adenovirus (rAd)-based vaccine, Gam-COVID-Vac (Sputnik V), showed a good safety profile and induced strong humoral and cellular immune responses in participants in phase 1/2 clinical trials. Here, we report preliminary results on the efficacy and safety of Gam-COVID-Vac from the interim analysis of this phase 3 trial.
Methods
We did a randomised, double-blind, placebo-controlled, phase 3 trial at 25 hospitals and polyclinics in Moscow, Russia. We included participants aged at least 18 years, with negative SARS-CoV-2 PCR and IgG and IgM tests, no infectious diseases in the 14 days before enrolment, and no other vaccinations in the 30 days before enrolment. Participants were randomly assigned (3:1) to receive vaccine or placebo, with stratification by age group. Investigators, participants, and all study staff were masked to group assignment. The vaccine was administered (0·5 mL/dose) intramuscularly in a prime-boost regimen: a 21-day interval between the first dose (rAd26) and the second dose (rAd5), both vectors carrying the gene for the full-length SARS-CoV-2 glycoprotein S. The primary outcome was the proportion of participants with PCR-confirmed COVID-19 from day 21 after receiving the first dose. All analyses excluded participants with protocol violations: the primary outcome was assessed in participants who had received two doses of vaccine or placebo, serious adverse events were assessed in all participants who had received at least one dose at the time of database lock, and rare adverse events were assessed in all participants who had received two doses and for whom all available data were verified in the case report form at the time of database lock. The trial is registered at ClinicalTrials.gov (NCT04530396).
Findings
Between Sept 7 and Nov 24, 2020, 21 977 adults were randomly assigned to the vaccine group (n=16 501) or the placebo group (n=5476). 19 866 received two doses of vaccine or placebo and were included in the primary outcome analysis. From 21 days after the first dose of vaccine (the day of dose 2), 16 (0·1%) of 14 964 participants in the vaccine group and 62 (1·3%) of 4902 in the placebo group were confirmed to have COVID-19; vaccine efficacy was 91·6% (95% CI 85·6–95·2). Most reported adverse events were grade 1 (7485 [94·0%] of 7966 total events). 45 (0·3%) of 16 427 participants in the vaccine group and 23 (0·4%) of 5435 participants in the placebo group had serious adverse events; none were considered associated with vaccination, with confirmation from the independent data monitoring committee. Four deaths were reported during the study (three [<0·1%] of 16 427 participants in the vaccine group and one [<0·1%] of 5435 participants in the placebo group), none of which were considered related to the vaccine.
Interpretation
This interim analysis of the phase 3 trial of Gam-COVID-Vac showed 91·6% efficacy against COVID-19 and was well tolerated in a large cohort.
Funding
Moscow City Health Department, Russian Direct Investment Fund, Sberbank, and RUSAL
[link url="https://www.businesslive.co.za/bd/national/health/2021-02-02-russian-sputnik-v-covid-19-vaccine-is-916-effective/"]Full Business Day report (Restricted access)[/link]
[link url="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2821%2900234-8/fulltext"]The Lancet study (Open access)[/link]