Russia’s vaccine ‘passes preliminary test’

A view of the Binnofarm pharmaceutical factory in the city of Zelenograd on the outskirts of Moscow on August 12, 2020, where Russia is starting to produce the coronavirus vaccine. Russia claimed it has developed the world’s first vaccine that offers “sustainable immunity” against the coronavirus, despite growing skepticism about its efficacy as fears mount about a second wave of infections around the world. President Vladimir Putin said the vaccine was safe and that one of his own daughters had received the inoculation, nicknamed “Sputnik” in honor of the pioneering Soviet satellite of the 1950s. Photo by Alexander NEMENOV / AFP

LONDON – Early tests of a Russian coronavirus vaccine showed encouraging results when details were released on Friday, but experts said the trials were too small to prove safety and efficacy.

Russia announced last month that its vaccine, named “Sputnik V” in honor of the Soviet-era satellite that was the first to be launched into space in 1957, had already received approval.

This raised concern among Western scientists about a lack of safety data, with some caveats that moving too fast on a vaccine could be dangerous.

Russia denounced the criticism as an attempt to undermine the Moscow investigation, and a Russian investor claimed their claim when the prestigious British journal Lancet published research showing that patients in early tests developed antibodies without “serious adverse effects.”

In the Lancet study, the Russian researchers reported on two small trials, each involving 38 healthy adults ages 18 to 60, who received a two-part immunization.

Each participant was given one dose of the first part of the vaccine and then boosted with the second part 21 days later.

They were monitored for 42 days and all developed antibodies within the first three weeks.

The report said the data showed the vaccine was “safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers.”

The trials were open-label and non-randomized, meaning there was no placebo and the participants knew they were receiving the vaccine and were not randomized to different treatment groups.

The researchers stressed that larger and longer trials, including a comparison with placebo, would be needed to establish the long-term safety and efficacy of the vaccine in preventing Covid-19 infection.

The report said the 76 participants in these trials would be monitored for up to 180 days, adding that a more rigorous phase 3 clinical trial involving 40,000 volunteers “of different age and risk groups” was planned.

‘Powerful answer to the skeptics’

Kirill Dmitriev, who runs a Russian investment fund behind the vaccine, told an online press conference in Moscow that the Lancet’s publication “is a powerful response to skeptics who unreasonably criticized the Russian vaccine.”

Independent experts were still cautious.

Naor Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health, who was not involved in the study, said the research was “encouraging but small,” adding that it did not provide any data on effectiveness among older age groups. , who are particularly vulnerable. to Covid-19.

“Showing safety will be crucial with Covid-19 vaccines, not just for vaccine acceptance, but for overall vaccination confidence,” he said in a comment in The Lancet.

“Since vaccines are administered to healthy people and, during the Covid-19 pandemic, potentially to all people after approval after phase 3 trials, safety is paramount.”

The pandemic has seen an unprecedented mobilization of funds and research to rush a vaccine that can protect billions of people around the world.

This week, the US urged states to prepare for a possible launch of the Covid-19 vaccine two days before the November presidential election, raising concerns that the administration of President Donald Trump is accelerating the investigation to adapt to a political calendar.

Objective of the ‘international market’

Russia has said that industrial production of its version is expected from September.

President Vladimir Putin said in early August that the vaccine provided “sustainable immunity” and that one of his own daughters had been inoculated, although Russia’s Health Ministry said clinical trials were not yet complete.

The World Health Organization has urged Russia to follow established guidelines and go “through all the stages” necessary to develop a safe vaccine.

Sputnik V was developed by the Gamaleya epidemiology and microbiology research institute in Moscow in coordination with the Russian defense ministry.

It uses a cold-causing adenovirus, which is then modified and combined with a part of the new coronavirus, SARS-CoV-2.

The report’s lead author, Denis Logunov of Gamaleya, said that the adenovirus vaccine enters people’s cells and delivers the genetic code for the SARS-CoV-2 spike protein, helping the immune system to “recognize and attack “the virus.

Dmitriev said that vaccine production “will initially be aimed at a Russian market, but we hope to have the possibility of supplying the vaccine to an international market,” indicating interest from around 40 countries.

The WHO insisted that it would never endorse a vaccine that has not been shown to be safe and effective and also said that it did not expect widespread immunization against the new coronavirus until mid-2021.

The organization said a total of 176 potential vaccines were in development worldwide, including 34 that are being tested in people. Among those eight are in stage three, the most advanced.

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