Russian scientists say the country’s Sputnik V vaccine appears safe and effective against COVID-19, according to early results of an advanced study published in a British medical journal, in a boost for a shot that is increasingly being bought by nations around the world who are desperate to stop the devastation caused by the pandemic.
Researchers say based on their trial, which involved about 20,000 people in Russia last autumn, the vaccine is about 91.6 percent effective and that the shot also appeared to prevent people from becoming severely ill with COVID-19. The study was published online on Tuesday in the journal, The Lancet.
“There are no arguments left for critics of this vaccine, the article in The Lancet is a checkmate,” said Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which was part of Sputnik V’s development.
Scientists not linked to the research acknowledged that the speed at which the Russian vaccine was made and rolled out was criticised for “unseemly haste, corner-cutting and an absence of transparency”.
“But the outcome reported here is clear,” British scientists Ian Jones and Polly Roy wrote in an accompanying commentary.
“Another vaccine can now join the fight to reduce the incidence of COVID-19.”
Following the study’s publication, health regulators in Mexico approved the Russian vaccine for emergency use, while the drugs’ company that will manufacture the vaccine in Brazil – the country’s with the world’s second highest number of deaths from coronavirus – said the findings were likely to expedite approvals for late stage trials.
“As soon as Brazil’s health regulator approves the trials, we will start and they will take 60-90 days,” União Quimica Chief Executive Officer Fernando Marques told Reuters news agency.
Health workers in Argentina started getting the vaccine on Tuesday.
The Sputnik V vaccine was approved by the Russian government with much fanfare on August 11. President Vladimir Putin personally broke the news on national television and said one of his daughters had already been vaccinated.
At the time, the vaccine had been tested only on a few dozen people, raising scepticism about its efficacy and safety.
Some early results were published in September, but participants had been followed for about 42 days only and there was no comparison group.
The latest study is based on research involving about 20,000 people aged above 18 at 25 hospitals in Moscow between September and November, of whom three-quarters got two doses of the Russian vaccine 21 days apart and the remainder got placebo shots.
The most commonly reported side effects were flu-like symptoms, pain at the injection site and fatigue. Serious side effects were rare in both groups and four deaths were reported in the study, although none was considered to be the result of the vaccine.
The study included more than 2,100 people over the age of 60 and the vaccine appeared to be about 92 percent effective, it said.
The research is continuing, but in December, Russia’s Health Ministry said it would cut the size of the study from the expected 40,000 to about 31,000 volunteers who have already enrolled. Developers of the vaccine cited ethical concerns about using placebo shots.
The Russian vaccine uses a modified version of the common cold-causing adenovirus to carry genes for the spike protein in the coronavirus as a way to prime the body to react if COVID-19 comes along.
That is a similar technology to the vaccine developed by AstraZeneca and Oxford University. But unlike that two-dose vaccine, the Russians used a slightly different adenovirus for the second booster shot.
Some experts say that approach may explain why the Russian vaccine seems to have produced a better immune response than the AstraZeneca vaccine, which has a reported an efficacy rate of 60-70 percent.
“This aims to drive higher immune responses to the target ‘spike’ by using two slightly different jabs,” said Alexander Edwards, an associate professor in biomedical technology at Britain’s University of Reading.
Sputnik V began being rolled out in a large-scale vaccination campaign in Russia in December, with doctors and teachers the first in line to get the shot.
Last month, Putin ordered the effort to be expanded and for mass immunisations to start.
Outside Russia, Sputnik V has received authorisation in more than a dozen countries, according to the fund – including former Soviet republics of Belarus, Armenia and Turkmenistan; Latin American nations including Argentina, Bolivia and Venezuela; some African nations as well as Serbia, Iran, Palestine, and the UAE.
In the European Union, the shot has received initial authorisation in Hungary and is still subject to final approval by the country’s National Public Health Center. Responding to the findings, German Chancellor Angela Merkel, said all vaccines were “welcome” in the EU as long as regulatory requirements were fulfilled.
Batches of the Russian vaccine have already been supplied to six countries. In all, more than 50 countries submitted applications for 2.4 billion doses, an RDIF spokesman told The Associated Press news agency.
Algeria will begin producing the Sputnik V vaccine “within the coming weeks”, according to Kamel Mansouri, the head of Algeria’s national agency for pharmaceuticals.
The first batch of 50,000 doses were flown to Algeria from Russia on Thursday, a 10th of what had been previously announced by the North African government. A cargo of 50,000 AstraZeneca doses arrived on Monday.
Mansouri said Algeria and Russia were in advanced discussions over Sputnik V and the vaccine would be manufactured at the government-owned SAIDAL facility.
“It is time that Algeria, a country that imports vaccine, be able to produce it on-site to respond to the needs of the vaccination campaign, and to export in a second phase,” he said on national television on Tuesday.
A new Oxford University study on AstraZeneca’s vaccine, meanwhile, has shown that the drug has 76 percent efficacy against symptomatic infection for three months after just a single dose.
The findings, which were published on Tuesday and have not been peer-reviewed, supported Britain’s decision to extend the interval between initial and booster doses of the shot to 12 weeks, Oxford said on Tuesday.
The AstraZeneca vaccine, which is cheap and easy to transport, is the backbone of the UK vaccination programme as well as a key part of the WHO-led COVAX initiative.
Nevertheless some countries have expressed concern about its efficacy among older patients.
France’s top health advisory body on Tuesday approved the use of the vaccine, but said the shot should only be administered to those aged under 65, echoing similar advice from experts in Italy, Austria, and Germany. Regulators there say there is not enough data to recommend use in older age groups.
“There is still insufficient data for those aged 65+. We hope to have them in the coming weeks,” the head of the HAS, Dominique Le Guludec, told reporters.