Russia COVID-19 vaccine trial results show it may be safe and effective

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Friday, September 4, 2020
Russian COVID-19 vaccine trials show no adverse side effects
All participants in the trials were able to generate antibodies to fight the virus, according to a report in The Lancet medical journal.

MOSCOW -- A vaccine being tested in Russia is showing promise at stopping COVID-19 in early trials, The Lancet medical journal reported Friday.

The doses known as Sputnik-V had no adverse events, meaning it was safe, and that it triggered an antibody response, the report stated.

Two trials conducted in June and July involved 76 participants who reported no serious side effects. All of the participants developed antibodies, according to The Lancet.

"The two 42-day trials - including 38 healthy adults each - did not find any serious adverse effects among participants, and confirmed that the vaccine candidates elicit an antibody response," The Lancet said.

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But with the results now published for the first time in an international peer-reviewed journal, and with a 40,000-strong later-stage trial launched last week, a senior Russian official said Moscow had faced down its critics abroad.

"With this (publication), we answer all of the questions of the West that were diligently asked over the past three weeks, frankly with the clear goal of tarnishing the Russian vaccine," said Kirill Dmitriev, the head of the Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, which has backed the vaccine.

"All of the boxes are checked," he told Reuters. "Now... we will start asking questions of some of the Western vaccines."

Dmitriev said at least 3,000 people had already been recruited for the large-scale trial of the Sputnik-V vaccine launched last week, and initial results were expected in October or November this year.

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Commenting on the results of the early-stage trials, lead author Dr. Naor Bar-Zeev of the International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, USA said the studies were "encouraging but small".

Bar-Zeev, who was not involved in the study, said "clinical efficacy for any COVID-19 vaccine has not yet been shown."

Governments and big pharmaceutical firms are racing to develop a vaccine to end the COVID-19 pandemic, which has killed more than 850,000 people globally and infected around 26 million.

More than half a dozen drugmakers are already conducting advanced clinical trials, each with tens of thousands of participants and several, including Britain's AstraZeneca and U.S. drugmakers Moderna and Pfizer expect to know if their COVID-19 vaccines work and are safe by the end of this year.

The Lancet said the early-stage trials suggested the Sputnik-V vaccine produced a response in a component of the immune system known as T cells.

Scientists have been scrutinizing the role played by T cells in battling coronavirus infection, with recent findings showing these cells may provide longer-term protection than antibodies.

The vaccine, developed by Moscow's Gamaleya Institute, is administered in two doses, with each based on a different vector that normally causes the common cold: human adenoviruses Ad5 and Ad26.

Some experts have said that using this delivery mechanism could make a COVID-19 vaccine less effective, since many people have already been exposed to the Ad5 adenovirus and developed immunity to it.

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