Phase III? What Phase III? Russia Approves Second COVID-19 Vaccine After 100 Person Trial
Two months ago, Russia planted its flag as the first coronavirus vaccine. This week, they rolled out their second vaccine, still leaps and bounds ahead of the rest of the world who’s currently engaged in rigorous testing to prove their candidate’s safety and efficacy.
Russia has apparently bypassed the Phase III portion and granted regulatory approval to the peptide-based drug, EpiVacCorona, which was developed by the Vector Institute in Siberia. In Phase II, 100 volunteers received the shot in Novosibirsk, the third most populous city in Russia. Results are yet to be published.
Despite the lack of any public results at this point, President Vladimir Putin said, “We need to increase production of the first and second vaccine. We are continuing to cooperate with our foreign partners and will promote our vaccine abroad.”
Experts had already raised the alarm in August over Russia’s first vaccine, a vector vaccine developed by Gamaleya Institute called their vaccine Sputnik V, a nod to Russia’s early success in the space race. Putin touted the safety and efficacy of this vaccine by reassuring the people that one of his own daughters was a recipient of the vaccine, which is just now ramping up Phase III testing. The Phase III testing of Sputnik started with residents of Siberia and has since administered the vaccine to trial participants in Belarus and soon the UAE. Further expansion is expected soon in Venezuela.
Sputnik V is a vector vaccine, which is produced on the basis of adenovirus. Former FDA Commissioner Dr. Scott Gottlieb had some doubts about the efficacy of this type of delivery system for a coronavirus vaccine, due to the fact that the viral vector being used is that of the common cold. So, if the recipient has antibodies against the common cold, their bodies neutralize the viral vector that’s being used to deliver the gene sequence.
The new Russian EpiVacCorona was created on the promising synthetic platform of peptide vaccines. These peptides are synthesized to cause the immune system to recognize and neutralize the virus. Peptide vaccines are beneficial in that they have a decreased risk of stimulating an autoimmune response or other adverse reactions. Deputy Prime Minister of Russia Tatiana Alekseevna said the Vector Institute will begin clinical trials with 40,000 volunteers soon.
Russia’s race to “be the first” in the coronavirus vaccine race has been called “reckless” by the scientific community. The Phase III trial phase is the largest, and its data essential for determining whether the drug actually works and if it is considered safe for most of the population. Fast approvals mean that adverse side effects may not have yet had time to be observed.
In August at the announcement of their first vaccine approval, Francois Balloux, an expert at University College London’s Genetics Institute called it a “foolish decision.”
“Mass vaccination with an improperly tested vaccine is unethical,” Balloux said. “Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.”
Even without seeing Russia’s results, there has been an increasingly negative perception of the COVID-19 vaccine, with now just 13% of Americans saying they would be willing to try a vaccine immediately once approved by the FDA. A mere 30% said they will plan to get it a few months after it becomes available.
Kirill Dmitriev, chief executive of Russia’s sovereign wealth fund, argued, “We’re completely transparent and open. There is a very negative narrative in some of the Western nations, and frankly we feel it’s very sad because basically it doesn’t allow people to have honest information on our vaccine. We all need to be very practical and stop this rhetoric of trying to paint each other’s vaccine black. It’s very unhealthy, it’s very unethical and very unproductive.”
Russia has yet to publish the results of the early-stage trials of EpiVacCorona. Meanwhile, they encourage countries to “test for themselves” and try it out.
Gotlieb reassured the American public saying that the US would not allow mass distribution of a drug that had only been tested on a few hundred patients at most.