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MOSCOW (Reuters) – Russian “Sputnik-V” COVID-19 vaccine produced an antibody response in all participants in early-stage trials, according to results published Friday by The Lancet medical journal that were hailed by Moscow as an answer to their criticism. .
Results from the two trials, conducted in June-July this year and involving 76 participants, showed that 100% of the participants developed antibodies to the new coronavirus and no serious side effects, The Lancet said.
Russia authorized the two-shot jab for home use in August, the first country to do so and before data was released or a full-scale test began.
“The two 42-day trials, which included 38 healthy adults each, found no serious adverse effects among participants and confirmed that vaccine candidates elicit an antibody response,” said The Lancet.
“Large, long-term trials that include a placebo comparison and greater control are needed to establish the long-term safety and efficacy of the vaccine in preventing COVID-19 infection,” he said.
The vaccine is called Sputnik-V in homage to the world’s first satellite, launched by the Soviet Union. Some Western experts have warned against its use until all tests and internationally approved regulatory steps have been taken.
But with the results now published for the first time in an international peer-reviewed journal, and with a later-stage trial of 40,000 people released last week, a senior Russian official said Moscow had faced its critics abroad.
“With this (post) we answer all the questions from the West that have been diligently asked over the past three weeks, frankly with the clear goal of tarnishing the Russian vaccine,” said Kirill Dmitriev, director of the Russian Direct Investment Fund (RDIF). , Russia’s sovereign wealth fund, which has backed the vaccine.
“All the boxes are checked,” he told Reuters. “Now … we will start asking questions about some of the western vaccines.”
Dmitriev said that at least 3,000 people had already been recruited for the large-scale trial of the Sputnik-V vaccine launched last week, with initial results expected in October or November this year.
Commenting on the results of the early stage trials, lead author Dr. Naor Bar-Zeev of the International Center for Access to Vaccines, 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 that “the clinical efficacy of any COVID-19 vaccine has not yet been demonstrated.”
RACE TO DEVELOP THE VACCINE
Governments and big pharmaceutical companies are rushing to develop a vaccine to end the COVID-19 pandemic, which has killed more than 850,000 people worldwide and infected some 26 million.
More than half a dozen drug manufacturers are already conducting advanced clinical trials, each with tens of thousands of participants and several, including Britain’s AstraZeneca and American pharmaceutical companies Moderna and Pfizer are waiting to find out if their COVID-19 vaccines work and they are safe by the end of this period. year.
The Lancet said early-stage trials suggested that the Sputnik-V vaccine produced a response in a component of the immune system known as T cells.
Scientists have been looking at the role T cells play in fighting coronavirus infection, with recent findings showing that these cells can provide longer-term protection than antibodies.
The vaccine, developed by the Gamaleya Institute in Moscow, is administered in two doses, 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 have developed immunity against it.
In China and the United States, about 40% of people have high levels of antibodies from previous exposure to Ad5. In Africa, it could be as high as 80%, experts have said.
Denis Logunov, one of the vaccine’s developers at the Gamaleya Institute, told Reuters that the vaccine uses a strong enough dose of Ad5 to overcome any previous immunity, without compromising safety.
The booster dose, based on the rarer Ad26 adenovirus, provides more support because the likelihood of widespread immunity to both types in the population is minimal, he said.
Russia has said it expects to produce between 1.5 million and 2 million doses per month of its potential COVID-19 vaccine by the end of the year, gradually increasing production to 6 million doses per month.
(Reporting by Andrew Osborn and Polina Ivanova; written by Polina Ivanova, edited by Timothy Heritage)
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