By Polina Ivanova
MOSCOW (Reuters) – Scientists gave the green light to the Russian Sputnik V vaccine on Tuesday, saying it was almost 92% effective in combating COVID-19 based on peer-reviewed end-stage test results published in the medical journal international The Lancet.
Experts said the results of the Phase III trial mean the world has another effective weapon to fight the deadly pandemic and justify, to some extent, Moscow’s decision to launch the vaccine before the final data is released.
The results, collected by the Gamaleya Institute in Moscow, which developed and tested the vaccine, were in line with efficacy data reported in earlier stages of the trial, which has been running in Moscow since September.
“The development of the Sputnik V vaccine has been criticized for improper haste, cutting corners and a lack of transparency,” said Ian Jones, a professor at the University of Reading, and Polly Roy, a professor at the London School of Hygiene & Tropical Medicine.
“But the result reported here is clear and the scientific principle of vaccination is demonstrated,” said the scientists, who were not involved in the study, in a comment shared by The Lancet. “Another vaccine may now join the fight to reduce the incidence of COVID-19.”
The results were based on data from 19,866 volunteers, of whom a quarter received a placebo, the researchers, led by Denis Logunov of the Gamaleya Institute, said in The Lancet.
Since the start of the trial in Moscow, there have been 16 reported cases of symptomatic COVID-19 among those who received the vaccine, and 62 among the placebo group, the scientists said.
This showed that a two-dose vaccine regimen – two injections based on two different viral vectors, administered 21 days apart – was 91.6% effective against symptomatic COVID-19.
‘RUSSIA WAS RIGHT’
The Sputnik V vaccine is the fourth worldwide to have Phase III results published in major peer-reviewed medical journals after vaccines developed by Pfizer and BioNTech, Moderna and AstraZeneca.
The Pfizer injection had the highest efficacy rate at 95%, closely followed by the Moderna and Sputnik V vaccine, while the AstraZeneca vaccine had an average efficacy of 70%.
Sputnik V has also been approved for storage in regular refrigerators, as opposed to freezers, making transportation and distribution easier, Gamaleya scientists said on Tuesday.
Russia approved the vaccine in August, before the large-scale trial began, saying it was the first country to do so for a COVID-19 vaccine. It was baptized as Sputnik V, in honor of the first satellite in the world, launched by the Soviet Union.
A small number of frontline health professionals began receiving him soon afterwards and a large-scale deployment began in December, although access was limited to those in specific professions, such as teachers, medical workers and journalists.
In January, the vaccine was offered to all Russians.
“Russia was right all along,” Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), responsible for marketing the vaccine abroad, told reporters.
He said the results supported Russia’s decision to start administering Sputnik V to frontline workers while the trial was still underway, and suggested that skepticism about such measures was politically motivated.
“Lancet did a very impartial job, despite some political pressures that may have existed,” he said.
EFFECTIVE IN ELDERLY
The number of people vaccinated in Russia has remained low so far. Authorities pointed to some initial problems with increased production, while surveys showed low demand among Russians for the vaccine.
Russia has already shared data from its Phase III trial with regulators in several countries and has started the process of submitting them to the European Medicines Agency (EMA) for approval in the European Union, said Dmitriev.
The data release comes at a time when Europe is struggling to ensure enough photos for its 450 million citizens due to production cuts by AstraZeneca and Pfizer. Deployment in the United States, in turn, was hampered by the need to store shots in deep-frozen freezers and uneven planning across states.
There were 2,144 volunteers over the age of 60 in the Sputnik V study and the injection proved to be 91.8% effective when tested in this older group, with no reports of serious side effects that could be associated with the vaccine, said the Lancet summary.
Dimitriev of RDIF also said that the Gamaleya Institute was testing the vaccine against new variants of COVID-19 and the first signs were positive.
The vaccine was also shown to be 100% effective against moderate or severe COVID-19, as there was no case among the group of 78 infected and symptomatic participants 21 days after the first injection.
Four deaths of participants occurred, but none were found to be associated with vaccination, said The Lancet.
“The effectiveness looks good, even in the 60s,” said Danny Altmann, professor of immunology at Imperial College London. “It is good to have one more addition to the global arsenal.”
DOSAGE VERSION
The study authors noted that, as the cases of COVID-19 were only detected when trial participants reported symptoms, further research was needed to understand the effectiveness of Sputnik V in asymptomatic and transmission cases.
Sputnik V has been approved by 15 countries, including Argentina, Hungary and the United Arab Emirates and will increase to 25 by the end of next week, said RDIF’s Dmitriev.
The sovereign wealth fund also said that vaccination with Sputnik V will begin in a dozen countries, including Bolivia, the United Arab Emirates, Venezuela and Iran.
Hungary was the first member of the European Union to break ranks and unilaterally approve the vaccine last month. It is scheduled to receive a first batch of 40,000 doses on Tuesday.
Germany said it would use Sputnik V if it was approved by Europe’s drug regulator, while France said it could buy any efficient vaccine.
However, large shipments of the vaccine have so far only been sent to Argentina, which has received enough doses to vaccinate about 500,000 people.
“Now all doubts have been clarified,” Argentine Science Minister Roberto Salvarezza told local radio La Red, citing “confirmation in a prestigious scientific publication”.
Export production will be done mainly by RDIF’s manufacturing partners abroad, the fund said.
On Tuesday, Dmitriev said production had started in India and South Korea and would be launched in China this month. Experimental doses were also produced by a manufacturer in Brazil.
Russia is conducting a small-scale clinical trial of a single-dose version of the vaccine, which developers expect to have an efficacy rate of 73% to 85%.
SOURCE: https://bit.ly/39Ggetm and https://bit.ly/3oNDKsM The Lancet, online on February 2, 2021.
Originally published