Russian Institute offers new evidence of success with additional data on COVID-19 vaccine Science

In September, a nurse will give a Moscow man the Sputnik V experimental COVID-19 vaccine, which new data say could successfully protect most people from the disease.

NATALIA KOLESNIKOVA / AFP through Getty Images

Written by Kai Kupferschmidt

ScienceThe COVID-19 report is supported by the Pulitzer Center and the Heising-Simons Foundation.

Joining the flood of press releases announcing the positive results of the COVID-19 vaccine trials, Russian Sputnik V vaccine developers today reported 91.4% efficacy from a second interim analysis of more than 18,000 people, confirming a claim the team substantiated with little evidence Nov. 11 -I. .

While the original report relied on only 20 cases of COVID-19 without detailing how they were distributed between the vaccinated and placebo groups, the new analysis is based on a total of 39 cases, eight among the vaccinated group compared to 31 in the much smaller placebo arm. “This is great news not only for Russia but for the world as well,” Kirill Dmitriev, CEO of a Russian direct investment fund banking the candidate’s development, announced at a virtual press conference this morning.

The Sputnik V vaccine, developed by the Gamaleya Center for Epidemiology and Microbiology in Moscow, uses adenovirus (Ad) “vectors” to deliver a gene that encodes the surface protein of the COVID-causing virus, SARS-CoV-2. -19. The two-dose regimen begins with Ad26-spike vaccination and is followed 21 days later by a booster shot containing Ad5. Gamaleya chose two different adenoviruses because he is concerned that an immune response to the same vector may reduce the effect of the booster shot.

Another adenovirus vaccine, developed by Oxford University and AstraZeneca, reported 70% efficacy data yesterday. It uses the same adenovirus vector for both the first and boost recordings. “Currently, the data released today for the Sputnik vaccine appear to be the best in adeno-vector vaccinations,” says Ian Jones, a virologist at the University of Reading. Chinese company CanSino Biologics and pharmaceutical giant Johnson & Johnson also have adenovirus vaccines against COVID-19 in efficacy trials.

The Russian results presented today represent an interim analysis of 18,794 participants 7 days after receiving the booster. (Only one in four received a placebo.) “While a [COVID-19] the number of cases is still small, it is extremely effective, ”Azra Ghani, an epidemiologist of infectious disease at Imperial College London, told Science Media Center. The ongoing trial will carry out the next interim analysis after 78 confirmed COVID-19 cases. In total, the organizers of the trial expect 40,000 participants.

The new report allays concerns raised by many vaccine researchers and public health experts when the Sputnik V team claimed earlier efficacy claims, Jones said. “I think the numbers are significant now, and I think they’re credible for what they say,” he says.

According to Dmitrijev, the researchers plan to publish the results of the trial in a journal reviewed by international experts. Denis Logunov, deputy director of the Gamaleya Center, notes that although side effects such as injection site pain, headache and fever have been observed, no serious adverse events have been reported. “There’s nothing unexpected,” he told a news conference.

One advantage of adenovirus vaccines is that they can be stored in standard refrigerators instead of requiring a freezer. Charlotte Houldcroft, a virologist at the University of Cambridge, warns that the latest Russian announcement is another example of a press release, but adds: “If the figures are as good as they seem, it’s really promising because it requires a standard cold chain, not ultra-cold chain than RNA vaccines, and that’s a big plus. “

“One thing seems clear that this platform works,” wrote Alexei Chumakov, a researcher at the Russian Academy of Medicine, the Chumakov Institute of Poliomyelitis and Viral Encephalitides in Moscow, in an email. “Of course, with all vaccines, and especially those with such potential for future revenue as well as political implications, one has to be careful in all sorts of statements, only time and tests will tell.”

According to Dmitrijev, partners in India, South Korea, China and Brazil are producing the vaccine, which can be shot for less than $ 10. Current agreements allow for the production of 1 billion batches in 2021, with the first batches being shipped internationally in January.