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MOSCOW: Scientists gave the green light to Russia’s Sputnik V vaccine on Tuesday (February 2) and said it was nearly 92% effective in fighting COVID-19 based on late-stage trial results reviewed by peers published in the international medical journal The Lancet.
Experts said the results of the Phase III trial meant that the world had another effective weapon to fight the deadly pandemic and to some extent justified Moscow’s decision to launch the vaccine before the final data was released.
The results, compiled by the Gamaleya Institute in Moscow that developed and tested the vaccine, matched 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 unseemly haste, corner cuts and a lack of transparency,” said Ian Jones, a professor at the University of Reading, and Polly Roy, a professor at the School of Hygiene and Medicine. Tropical London. .
“But the result reported here is clear and the scientific principle of vaccination is proven,” 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.”
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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 trial began in Moscow, there have been 16 recorded cases of symptomatic COVID-19 among the people who received the vaccine and 62 among the placebo group, the scientists said.
This showed that a two-dose regimen of the vaccine (two injections based on two different viral vectors, given 21 days apart) was 91.6% effective against symptomatic COVID-19.
‘Russia was right’
The Sputnik V vaccine is the fourth in the world to have Phase III results published in leading peer-reviewed medical journals following vaccines developed by Pfizer and BioNTech, Moderna and AstraZeneca.
The Pfizer injection had the highest efficacy rate at 95 percent, followed closely by the Moderna and Sputnik V vaccine, while the AstraZeneca vaccine had an average efficacy of 70 percent.
Sputnik V has also been approved for storage in normal refrigerators, rather than freezers, making it easier to transport and distribute, Gamaleya scientists said Tuesday.
Russia approved the vaccine in August, before the large-scale trial began, and said it was the first country to do so for a COVID-19 injection. He named it Sputnik V, in homage to the world’s first satellite, launched by the Soviet Union.
A small number of frontline health workers began receiving it soon after, 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.
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“Russia was right from the beginning,” Kirill Dmitriev, director of the Russian Direct Investment Fund (RDIF), responsible for marketing the vaccine abroad, told reporters on Tuesday.
He said the results supported Russia’s decision to start administering Sputnik V to front-line workers while the trial was still ongoing, and suggested that the skepticism of such movements was politically motivated.
“The Lancet did a very impartial job despite some of the political pressure that may have existed,” he said.
The Sputnik V COVID-19 vaccine is administered at a hospital in the town of Donskoye in Russia’s Stavropol region on January 27, 2021 (File Photo: Reuters / Eduard Korniyenko).
EFFECTIVE IN ELDERLY
The number of vaccinated people in Russia has remained low so far. Authorities have pointed to some initial problems with increased production, while polls have shown 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 it to the European Medicines Agency (EMA) for approval in the European Union, Dmitriev said.
The data release comes as Europe struggles to secure enough shots for its 450 million citizens due to production cuts from AstraZeneca and Pfizer. Meanwhile, the US rollout has been hampered by the need to store the intakes in ultra-cold freezers and uneven planning across the states.
There were 2,144 volunteers over the age of 60 in the Sputnik V trial and the injection was shown to be 91.8% effective when tested in this older age group, with no reported serious side effects that could be associated with the vaccine, according to The Lancet abstract.
RDIF’s Dimitriev also said that the Gamaleya Institute was testing the vaccine against new variants of COVID-19 and that the first signs were positive.
The vaccine was also found to be 100 percent effective against moderate or severe COVID-19, as there were no such cases among the group of 78 participants who were infected and symptomatic 21 days after the first injection was administered.
There were four participant deaths, but none were considered associated with vaccination, The Lancet said.
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“Efficacy seems good, even in those over 60,” said Danny Altmann, professor of immunology at Imperial College London. “It’s good to have another addition to the global arsenal.”
ONE DOSE VERSION
The study authors noted that because COVID-19 cases were only detected when trial participants reported symptoms, more research was needed to understand the efficacy of Sputnik V in asymptomatic cases and transmission.
Sputnik V has been approved by 15 countries, including Argentina, Hungary and the United Arab Emirates and this will increase to 25 by the end of next week, said RDIF’s Dmitriev.
The sovereign wealth fund also said that Sputnik V vaccines 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 has said it would use Sputnik V if approved by the European drug regulator, while France has said it could buy any efficient vaccine.
However, so far only large shipments of the vaccine have been sent to Argentina, which has received enough doses to vaccinate about 500,000 people.
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“Now all doubts are cleared,” Argentine Science Minister Roberto Salvarezza told local radio La Red, citing “confirmation in a prestigious scientific publication.”
Production for export will be carried out primarily by RDIF’s overseas manufacturing partners, according to the fund.
On Tuesday, Dmitriev said production had started in India and South Korea, and would launch in China this month. A manufacturer in Brazil has also produced test doses.
Russia is conducting a small-scale clinical trial of a one-dose version of the vaccine, which developers expect to have an efficacy rate of 73% to 85%.
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