Russia’s Covid-19 vaccine was highly effective in one trial, research finds, boosting Moscow’s ambitions to roll out

The study could be an important milestone for Moscow in the global vaccination race, potentially opening the geopolitical influence of President Vladimir Putin’s government in the developing world and an opportunity to tap into the lucrative global vaccine market. Russia – the fourth most affected country in the world with nearly four million cases – has also counted on Sputnik V to avoid new costly lockdowns, as authorities plan to reduce 60% of the domestic population by the end of the year. vaccinate.

The shot, which was approved by Russian authorities in August before undergoing large-scale clinical trials, has raised questions in light of its rapid development and lack of published trial data. According to Russian authorities, Sputnik V has so far been administered to more than two million people worldwide, including in Argentina, Serbia and Algeria.

Tuesday’s results could clear doubts about the Russian shot.

“The development of the Sputnik V vaccine has been criticized for its inappropriate haste, cutting corners and lack of transparency,” wrote virology professors Ian Jones of the UK’s University of Reading and Polly Roy of the London School of Hygiene & Tropical Medicine. in the Lancet. “But the outcome reported here is clear and the scientific principle of vaccination has been demonstrated, meaning that another vaccine can now participate in the fight to reduce the incidence of Covid-19.”

Alexander Gintsburg, the head of the vaccine’s developer, the Moscow-based Gamaleya Institute, said the data shows the safety and high efficacy of Sputnik V against the virus.

This “is a great success in the global fight against the Covid-19 pandemic,” he said.

The effectiveness of Sputnik V is comparable to vaccines developed by Moderna Inc.

and Pfizer Inc.

and its German partner BioNTech SE,

which are about 95% effective.

The Lancet study did not address the usefulness of the shot against new variants of the virus, amid some early evidence suggesting strains may prove resistant to current vaccines. Russian officials have said they expect the shot to work against other variants and that investigations continue.

The results published Tuesday were based on an interim analysis of a phase 3 study involving nearly 20,000 participants, three-quarters of whom received the vaccine and the rest a placebo. The analysis was based on a total of 78 confirmed Covid-19 cases, of which 62 in the placebo group and 16 in the vaccine group. The clinical trial, involving a total of 40,000 volunteers, is underway.

Researchers found that the Covid-19 vaccine did not cause serious side effects, according to the Lancet paper. Most side effects were flu-like symptoms, injection site pain, and headache.

Among the elderly, the vaccine was well tolerated and showed an efficacy of 91.8%, based on a group of 2,144 volunteers over the age of 60, the paper said.

Like other Covid-19 vaccines, including vaccines developed by Johnson & Johnson and AstraZeneca PLC and Oxford University, Sputnik V uses what is called a viral vector approach. It introduces a genetically modified form of a harmless virus, known as the adenovirus, that serves as a carrier – or vector – for a fragment of coronavirus genetic material.

Each of the two injections of the vaccine is based on a different adenovirus vector, which Russian scientists say achieves a stronger immune response. Sputnik V has simpler logistics requirements compared to some of its peers, with a storage and shipping temperature between 36 and 46 degrees Fahrenheit. The Pfizer vaccine must be stored at minus 94 degrees Fahrenheit before thawing.

With Sputnik V – a reference to the satellite that the Soviet Union launched into orbit ahead of the US during the Cold War space race – Russia could gain influence with some countries, analysts say, and could also participate to a global market for coronavirus vaccines estimated by Russian officials. on $ 100 billion a year.

Russia, which competes on price, sells the vaccine for less than $ 10 per dose, lower than Pfizer and Moderna, and is targeting a 30% market share of Covid-19 shots in the countries buying Sputnik, Russian officials said.

AstraZeneca has said it would test whether a combination of its Covid-19 vaccine, which has been shown to be between 62% and 90% effective, depending on the dosage, and Sputnik V can increase its effectiveness. Clinical trials for a combined injection are expected to start soon in Azerbaijan, the United Arab Emirates and other countries.

About 15 countries outside Russia have already authorized Sputnik V, and Moscow has received orders or expressions of interest for 2.4 billion doses, including from Brazil, Mexico and India. In an effort to accelerate the global rollout, Russia will also offer a single-dose vaccine called Sputnik Light, which according to Russian authorities would be between 73% and 85% effective.

For the production of its vaccine, Russia relies on a global supply chain, including manufacturing hubs in Brazil, South Korea, India and China. Russia has also set up an aggressive PR campaign abroad, including posting weekly video updates in English and maintaining a Twitter account for Sputnik V.

Sputnik V has not been approved by Western health authorities or has not received approval from the World Health Organization, which many developing countries rely on for vaccine screening. Russia is in talks with the European Medicines Agency about the approval of the shot in the European Union and has applied for WHO authorization.

Domestic rollout has also faced challenges, including production delays and a skeptical population.

Authorities recently said production is now ramping up after initial equipment issues. They now expect to produce 11 million doses this month, up from 7 million in January.

About 46% of Russians said they would receive a vaccine in a January poll by the UK polling station Ipsos MORI, up 5 percentage points from December. Still, Russians were among the most reluctant to get vaccinated worldwide, compared to 55% in France, 63% in the US and 86% in the UK

Russia does not publish a daily vaccination coverage, but regional data shows that at least 1.3 million Russians have been dosed so far.

Irina Levashova, a kindergarten teacher in Romodanovo, a small town some 400 miles southeast of Moscow, received her second injection last month, along with her husband.

“I have many acquaintances who have been ill or even died from this disease, so I wanted to protect myself and my family,” said Ms. Levashova, 58, adding that she didn’t experience any serious side effects. “As soon as they started talking about vaccinations, I immediately said to myself that I and my family would do it.”

—Valentina Ochirova contributed to this article

Write to Georgi Kantchev at [email protected]