President Vladimir Putin announced on Tuesday that his country had developed the Gamaleya vaccine against the pandemic. Putin claimed that his daughter had received the treatment and that he was certain of its effectiveness. He said it formed a strong immunity and that it had ticked all the necessary boxes.
However, Professor Shabir Madhi, trial head for the Oxford vaccine study in South Africa and professor of vaccinology at Wits University, has poured cold water on the claims saying the licensing of the vaccine was premature.
Madhi said no data on the safety of the vaccine had been released yet therefore no concrete evidence was available on the type of immune response the vaccine infused.
“The country needed to do what the rest of the global scientific community is doing and that is to test the vaccine through proper stages. They have only done an equivalent of a phase one study and you do not license vaccines based on phase one studies,” Madhi said.
“If the licensing was based on what they are doing, then right now we would have at least ten different vaccines licensed but that is not the case because others are being more responsible in the manner in which they are going about doing their evaluations to ensure safety.”
Professor Tulio de Oliveira, director of the KwaZulu-Natal Research Innovation and Sequencing Platform (KRISP) at UKZN, explained that clinical development was a three phase process and that it was unclear which level Russia had already completed.
He said the country’s decision to make an announcement prior to the completion of phase three had been a hasty one.
Under normal circumstances, phase one and two results are published and that has not happened yet with Russia.
“Phase three of vaccine trials is the most important one, that is when you test not only the safety of the vaccine but also the effectiveness,” he said.
He explained that scientists give the vaccine to a number of people and wait to see how many become infected, compared with volunteers who received a placebo. Results can determine if the vaccine protects against Covid-19.
“When you run a double blinded trial people will receive either a placebo or a dose of the vaccine and you measure over a given time how many people acquired the virus or were infected with the virus.
“If the vaccine is highly efficient it should protect against infection, the coronavirus and the placebo results should be quite similar to the normal population.”
De Oliviera mentioned that Russia was not the first country to claim to have an effective vaccine.
He said the UK was also guilty of drawing contracts with various countries prior to completing all trial phases of its Oxford vaccine.
“The US is doing the same, they are running two or three potential vaccines that are in a phase three trial and they also advertised that they are close to developing a vaccine,” he said.
De Oliveira said there was now an evident decrease in numbers of transmissions, however, it was the responsibility of communities to ensure their safety by following protocols in place as we progress to lower lockdown levels.
“Our government has been very decisive during this pandemic and they are following every best case scenario on how to control the virus.”