The move by the medical products regulatory body of Russia to approve Covid-19 vaccine before completing clinical trial steps has attracted mixed reactions from experts.
Russia has not released any report about the clinical trial of the approved vaccine.
The vaccine is said to have completed the first and second clinical trial phases, awaiting the third phase expected to start in October, Russia’s health ministry said.
Although most scientists have criticised Russia for violating the important protocol required to come up with a safe vaccine, others say following the lengthy phases of a clinical trial in a time when dozens of people are dying from Covid-19, is irrational.
While announcing the development yesterday, Russian President Vladimir Putin said the vaccine has gone through all the necessary steps.
Mr Putin also said he had given the vaccine to his daughter, who was feeling fine despite having a brief rise in temperature.
“It works effectively enough for a stable immunity and, it has gone through all necessary tests...This [is the] first, important step for our country, and generally for the whole world,” the New York Times quoted Mr Putin to have told a cabinet meeting on Tuesday.
“After the first injection, her (Putin’s daughter) temperature was 38 degrees, the next day 37.5, and that was it. After the second injection, her temperature went up slightly, then back to normal,” BBC quoted Mr Putin to have said.
Dr Bruce Kirenga, the head of Makerere Lung Institute, said although it would have been very important that the scientists in Russia shared the clinical trial report for scrutiny, it is wrong to blame Russia for rushing.
“I even think we delayed to come up with a vaccine. The existing system of developing treatment is costing us a lot of lives; why do you take a month to review a document yet people are dying?” he asked. Dr Kirenga said the approval process for a vaccine or drug takes longer than the actual time needed to develop the product.
“For any vaccine or anything that prevents disease, the key determinant is the incubation period for the remedy. For instance, within two to three weeks, you can be able to know that the vaccine works against Covid-19 or not,” he said.
“What would give the scientists proof of this vaccine is if there was a publication about the vaccine to help scientists make a better conclusion about it,” he added.
Prof Moses Joloba, the dean of School of Biomedical Sciences and head of Makerere University laboratory that is testing for Covid-19, said they will be interested in testing the vaccine to see if it works.
“The world is in the process of finding a vaccine for Covid-19, I don’t think there is worldwide consensus that we found a vaccine already. In science there is what we call reproducibility; if you say something works, you put it out and other people also test and see if it works,” he said.
Dr Andrew Kambugu, the head of Infectious Diseases Institute, cautioned the public to go slow on the vaccine.
“The vaccine should go through all the phases of testing and regulatory approvals, including the national ones in the case of Uganda,” he said.
The vaccine is manufactured by Gamaleya Research Centre. It uses two strains of adenovirus that typically cause mild colds in humans. The adenovirus used are genetically modified to cause infected cells to make proteins from the spike of the new coronavirus. This method of vaccine development is similar to that of the Oxford University and AstraZenaca vaccine which is being tried in Britain, South Africa and Brazil.