Enbal Sabag, a nurse, promotes immunization for a patient at CVS Pharmacy at MinuteClinic on September 03, 2020, in Key Biscayne, Florida. Joe Raedle / Getty Images / AFP
Patients involved in the first trial of Russia’s coronavirus developed a vaccine without “serious side effects”, according to a study published in Lancet Friday, but experts said the tests were too small to demonstrate safety and effectiveness.
Russia announced last month that its anti-aircraft missile, dubbed “Sputnik V” after the first Soviet satellite launched into space in 1957, has received support.
This has raised concerns among western scientists over the lack of safety data, as well as some warnings that moving too quickly with vaccines could be dangerous.
Russia has criticized the criticism as an attempt to undermine Moscow’s investigation.
In the Lancet study, Russian researchers reported two small trials, each involving 38 healthy adults between the ages of 18 and 60, who were given double-dose vaccines.
Each participant was given the first dose of the vaccine and given the second dose after 21 days.
They were tested for more than 42 days and all vaccines developed within the first three weeks.
The statement said data showed that the vaccine was “safe, well tolerated, does not cause serious harm to healthy adult volunteers”.
The trials were open and randomized, meaning that there was no placebo and participants were aware that they were receiving the vaccine and were not assigned to the same treatment regimen.
Researchers point out that large and long-term trials — including placebo comparisons — will be needed to establish long-term safety as well as the effectiveness of antibiotics for the prevention of Covid-19 disease.
The statement said the 76 participants would be screened for 180 days, adding that a third rigorous clinical trial was planned with the participation of 40,000 volunteers “from different ages and those with threats “.
‘Safety is important’
Naor Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health, who was not involved in the study, said the study was “encouraging but limited”, adding that it did not provide any data for effective among the elderly, the infirm. for Covid-19.
“Demonstration of safety will be critical to Covid-19 vaccines, not only for the acceptance of vaccines but also for the reliability of vaccines,” he said in a statement to the Lancet.
“Since immunization is provided to health care providers and, during the course of COVID-19, it can be given to everyone after the third dose, safety is extremely important.”
The epidemic has seen an unprecedented amount of money and research to speed up vaccination that could protect billions of people worldwide.
This week, the U.S. urged states to be prepared for the launch of the Covid-19 vaccine two days before the November presidential election, sparking concerns President Donald Trump’s administration is conducting a quick investigation. to support the political process.
Russia has said it is expected to produce a new version of its model by September.
President Vladimir Putin said in early August that the vaccine had provided “permanent protection” and extended one of his daughters, although Russian health information said hospital trials had not yet ended.
The World Health Organization has urged Russia to follow the guidelines and go through the “necessary procedures” to develop vaccines.
Sputnik V developed the Gamaleya research center for infectious diseases and microbiology in Moscow with the design and processing of Russian information.
It uses the cold-blooded adenovirus, which is modified and linked to a new component of the coronavirus, SARS-CoV-2.
The report’s editor-in-chief, Denis Logunov of Gamaleya, said the adenovirus vaccine enters human cells and releases SARS-CoV-2 protein, helping the immune system ” identify and fight the ” virus.