By Polina Ivanova
MOSCOW (Reuters) – Scientists gave the Russian Sputnik V vaccine the green light on Tuesday, saying it was nearly 92% effective in the fight against COVID-19 based on peer-reviewed late-stage research results published in the International Medical Journal The Lancet.
Experts said the results of the phase III study meant the world had another effective weapon to combat the deadly pandemic and, to some extent, justified Moscow’s decision to roll out the vaccine before final data was released.
The results, collected by the Gamaleya Institute in Moscow that developed and tested the vaccine, were in line with the efficacy data reported in earlier stages of the trial, which has been conducted in Moscow since September.
“The development of the Sputnik V vaccine has been criticized for its inappropriate haste, cutting corners and lack of transparency,” said Ian Jones, professor at the University of Reading, and Polly Roy, professor at the London School of Hygiene. Tropical Medicine. .
“But the outcome reported here is clear and the scientific principle of vaccination has been demonstrated,” said the scientists, who were not involved in the study, in a commentary shared by The Lancet. “Another vaccine can now join the fight to reduce the incidence of COVID-19.”
The results were based on data from 19,866 volunteers, a quarter of whom 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 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 administered 21 days apart – was 91.6% effective against symptomatic COVID-19.
‘RUSSIA WAS RIGHT’
The Sputnik V vaccine is the fourth worldwide whose Phase III results have been published in leading peer-reviewed medical journals in response to the shots developed by Pfizer and BioNTech, Moderna and AstraZeneca.
The Pfizer injection had the highest efficacy rate at 95%, followed closely by the Moderna and Sputnik V vaccines, while the AstraZeneca vaccine had an average efficacy of 70%.
Sputnik V is now also approved for storage in regular refrigerators, as opposed to freezers, making transportation and distribution easier, Gamaleya scientists said 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 injection. It called it Sputnik V, in tribute to the world’s first satellite launched by the Soviet Union.
Small numbers of primary health workers got it soon after and a large-scale rollout began in December, although access was limited to people in specific professions, such as teachers, medical staff and journalists.
In January, the vaccine was offered to all Russians.
“Russia was always right,” Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine abroad, told reporters on Tuesday.
He said the results supported Russia’s decision to start administering Sputnik V to frontline workers while the trial was still underway, and suggested skepticism about such moves was politically motivated.
“The Lancet has done a very unbiased work despite some of the political pressure that may have been there,” he said.
EFFECTIVE WITH THE ELDERLY
The number of vaccinated people in Russia has remained low so far. Authorities have pointed to some early problems with scaling up production, while polls have shown that there is little demand for the vaccine among Russians.
Russia has already shared the data from its Phase III study with regulators in several countries and has begun submitting it to the European Medicines Agency (EMA) for approval in the European Union, Dmitriev said.
The data is released as Europe works to provide enough footage for its 450 million residents due to production cuts by AstraZeneca and Pfizer. US rollout, meanwhile, has been hampered by the need to store shots in ultra-cold freezers and uneven scheduling between states.
There were 2,144 volunteers over 60 in the Sputnik V study and the injection was found to be 91.8% effective when tested in this older group, with no serious adverse reactions reported that could be related to the vaccine, the summary of The Lancet.
RDIF’s Dimitriev also said that the Gamaleya Institute tested the vaccine against new variants of COVID-19 and that the first signs were positive.
The vaccine was also found to be 100% effective against moderate or severe COVID-19, as there were no such cases in the group of 78 participants who were infected 21 days after the first injection and were symptomatic.
Four participants’ deaths occurred, but none were considered to be associated with vaccination, The Lancet said.
“The efficacy looks good even in the 1960s,” said Danny Altmann, professor of immunology at Imperial College London. “It’s good to have one more addition to the global arsenal.”
ONE DOSE VERSION
The study authors noted that because COVID-19 cases were only detected when subjects reported symptoms, further 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 rise to 25 by the end of next week, Dmitriev of the RDIF said.
The sovereign wealth fund also said Sputnik V vaccinations 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 last month and unilaterally approve the vaccine. It will receive an initial 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, large shipments of the shot have so far only been sent to Argentina, which has received enough doses to vaccinate about 500,000 people.
“Now all doubts have been dispelled,” Argentina’s Science Minister Roberto Salvarezza told local radio station La Red, citing “the confirmation in a prestigious scientific publication.”
Production for export will mainly be done by RDIF’s manufacturing partners abroad, the fund said.
On Tuesday, Dmitriev said production had started in India and South Korea and would start in China this month. Trial doses have also been produced by a manufacturer in Brazil.
Russia is conducting a small-scale clinical trial of a single-dose version of the vaccine, which the developers expect will have an efficacy rate of 73% to 85%.
SOURCE: https://bit.ly/39Ggetm and https://bit.ly/3oNDKsM The Lancet, online Feb 2, 2021.
Originally published