Russia’s Sputnik V vaccine is 92% effective at protecting people from Covid-19, according to interim trial results, the country’s sovereign wealth fund said on Wednesday, as Moscow rushes to keep pace with western drugmakers in the race for a shot.
The initial results are only the second to be published from a late-stage human trial in the global effort to produce vaccines that could halt a pandemic that has killed more than 1.2 million people and ravaged the world economy.
Russia registered its Covid-19 vaccine for public use in August, the first country to do so, though the approval came before the start of the large-scale trial in September.
“We are showing, based on the data, that we have a very effective vaccine,” said Russian Direct Investment Fund (RDIF) head Kirill Dmitriev, adding that it was the sort of news the vaccine’s developers would talk about one day with their grandchildren.
The interim results are based on data from the first 16,000 trial participants to receive both shots of the two-dose vaccine, the RDIF, which has been backing the vaccine and marketing it globally, said.
The interim analysis was conducted after 20 participants in the trial developed Covid-19 and examined how many had received the vaccine vs a placebo.
That is significantly lower than the 94 infections in the trial of a vaccine being developed by Pfizer and BioNTech. To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 Covid-19 cases.
The Russian trial will continue for six more months, RDIF said, and data from the trial will also be published in a leading international medical journal after a peer review.
The so-called Phase III trial of the shot, developed by the Gamaleya Institute, is taking place in 29 clinics across Moscow and will involve 40,000 volunteers, with a quarter receiving a placebo.
The chances of contracting Covid-19 were 92% lower among people vaccinated with Sputnik V than those who received the placebo, the RDIF said. That’s well above the 50% effectiveness threshold for Covid-19 vaccines set by the US Food and Drug Administration (FDA).
Russia’s announcement follows swiftly on from results posted on Monday by Pfizer and BioNTech, who said their shot was also more than 90% effective.
The companies’ vaccine uses messenger RNA (mRNA) technology and is designed to trigger an immune response without using pathogens, such as actual virus particles.
The Sputnik V vaccine is designed to trigger a response from two shots administered 21 days apart, each based on different viral vectors that normally cause the common cold: human adenoviruses Ad5 and Ad26.
The drug is named Sputnik V after the Soviet-era satellite that triggered the space race, a nod to the project’s geopolitical importance for president Vladimir Putin.
Russia is also testing a different vaccine, produced by the Vector Institute in Siberia, and is on the cusp of registering a third, Putin said on Tuesday, adding that all of the country’s vaccines were effective.
“Studies have already shown and confirmed that, firstly, these vaccines are safe and have no serious side effects after use, and secondly, they are all effective,” the RIA news agency quoted Putin as saying.
RDIF said no serious side effects had been reported during the Sputnik V Phase III trial so far.
The publication of the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccine’s efficacy gives way to mass vaccination in Russia against Covid-19 in the coming weeks.
— Alexander Gintsburg, Gamaleya Research Institute of Epidemiology and Microbiology
Successful vaccines are seen as crucial to restoring daily life around the world by helping end the health crisis that shuttered businesses and put millions out of work.
Russia has also inoculated 10,000 people considered at high risk of Covid-19 outside the trial.
Putin has said the country expects to start mass vaccinations by the end of the year.
“The publication of the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccine’s efficacy gives way to mass vaccination in Russia against Covid-19 in the coming weeks,” Alexander Gintsburg, director of the Gamaleya Research Institute of Epidemiology and Microbiology, said.
Moscow is rolling out a large network of vaccination rooms and residents who want the shot may be able to get it as early as next month if large volumes of doses are supplied by then, deputy mayor Anastasia Rakova said on October 30.
However, production challenges remain. Earlier estimates that Russia could produce 30 million doses of the vaccine this year have since been scaled down. Moscow aims to produce 800,000 doses this month, industry minister Denis Manturov has said, followed by 1.5 million in December. But significantly higher volumes of output per month are expected from early 2021.
Manturov cited issues with scaling up production from small- to large-volume bioreactors, while Putin last month cited issues with the availability of equipment. Officials have said that domestic production of the vaccine will be used first to meet Russia’s needs.
RDIF, however, has also struck several international supply deals, amounting to 270 million doses. It is expected that these will in large part be produced in other countries and RDIF has previously announced a deal to manufacture 300 million doses in India and an undisclosed amount of doses in Brazil, China and South Korea.
Trials of the vaccine have also begun in Belarus and are on track to begin soon in the United Arab Emirates, Venezuela and India.
Russia reported 19,851 new coronavirus infections in the past 24 hours and a record high of 432 deaths. At 1,836,960, its overall case tally is the fifth-largest in the world, behind the US, India, Brazil and France.
Authorities, however, have been adamant that severe lockdown restrictions will not be reintroduced.
Mass mink deaths spark fears of human risk
More than 15,000 mink in the US have died of coronavirus since August and authorities are keeping about a dozen farms under quarantine while they investigate the cases, state agriculture officials said.
Global health officials are eying the animals as a potential risk for people after Denmark last week embarked on a plan to eliminate all of its 17 million mink, saying a mutated coronavirus strain could move to humans and evade future Covid-19 vaccines.
The US states of Utah, Wisconsin and Michigan, where the coronavirus has killed mink, said they do not plan to cull animals and are monitoring the situation in Denmark.
“We believe that quarantining affected mink farms, in addition to implementing stringent biosecurity measures, will succeed in controlling SARS-CoV-2 at these locations,” the US department of agriculture (USDA) said on Tuesday.
It said it is working with the US Centers for Disease Control and Prevention (CDC), state officials and the mink industry to test and monitor infected farms.
The US has 359,850 mink bred to produce babies, known as kits, and produced 2.7 million pelts in 2019. Wisconsin is the largest mink-producing state, followed by Utah.
Sick mink in Wisconsin and Utah were exposed to people with probable or confirmed Covid-19 cases, the USDA said. In Michigan it is still unknown if the mink were infected by humans, according to the agency.
In Utah, the first US state to confirm mink infections in August, about 10,700 mink have died on nine farms, said state veterinarian Dean Taylor.
“On all nine, everything is still suggesting a one-way travel from people to the minks,” he said. Coronavirus testing has been done on mink that die and randomly on the affected farms, Taylor said. Like people, some mink are asymptomatic or mildly affected, he added.
I’m fairly confident that as long as they have that surveillance going and it’s strong enough, then they should be able to prevent the spread.
— Virologist Richard Webby
The CDC said it was supporting states’ investigations into sick mink, including testing of animals and people.
“These investigations will help us to learn more about the transmission dynamics between mink, other animals around the farms and people,” the CDC said. “Currently, there is no evidence that animals play a significant role in the spread of SARS-CoV-2 to people.”
Coronavirus is thought to have first jumped to humans from animals in China, possibly from bats or another animal at a food market in Wuhan, though many questions remain.
Monitoring US mink for virus symptoms and quarantining infected farms should limit the disease’s spread if cases are caught early, said Richard Webby, a virologist at St Jude Children’s Research Hospital in Memphis.
“I’m fairly confident that as long as they have that surveillance going and it’s strong enough, then they should be able to prevent the spread,” he said.
US authorities are urging farmers to wear protective gear such as masks and gloves when handling mink to avoid infecting the animals.
In Wisconsin, about 5,000 mink have died on two farms, state veterinarian Darlene Konkle said.
One farm is composting the dead mink to dispose of the carcasses without spreading the virus, Konkle said. Authorities are working with the second farm to determine how to dispose of the mink and dead animals are being kept in a metal container in the meantime, she said.
Michigan declined to disclose how many mink had died, citing privacy rules.
State officials said they are working with the USDA to determine whether farmers can sell the pelts of infected mink. The pelts are used to make fur coats and other items.
The coronavirus has also infected cats, dogs, a lion and a tiger, according to the USDA. Experts say mink appear to be the most susceptible animals so far. — Tom Polansek, additional reporting by Carl O’Donnell
– Reuters
