(CN) — Tens of thousands of Russians will be given a vaccine against the coronavirus after President Vladimir Putin announced approval Tuesday for a drug that has not undergone the most critical phase of its clinical trials.
In a cabinet meeting where he revealed that the vaccine has been dubbed Sputnik V, after the first Soviet satellite, Putin asserted that one of his two adult daughters has already received a dose.
“It works effectively enough, forms a stable immunity, and, I repeat, it has gone through all the necessary tests,” Putin said Tuesday morning.
Though the announcement ostensibly makes Russia first in a global race to roll out a vaccination against the novel coronavirus, Sputnik V’s developers at the Gamaleya Institute have yet to run phase-three tests on the injection — a process that would involve a highly controlled trial involving tens of thousands of volunteers. Since human trial testing of Sputnik V began in mid-June, the vaccine has only been tested on 76 volunteers, some of whom were recruited from the military.
The World Health Organization has maintained that all vaccine candidates should go through full stages of testing — completing the third phase of a clinical trial — before being made available to the public. By rolling out a vaccine that does not function as intended, experts warn that there is harm both to those who receive the vaccine, because they are at risk of suffering negative health impacts, and to the public.
“An ineffective vaccine can give a false sense of security to someone who received the vaccine, who may then not adhere to social-distancing practices,” Lee Riley, a professor of epidemiology at the University of California, Berkeley, explained in an interview Tuesday. “This will create a large reservoir of infected people and the pandemic can get even worse.”
More broadly, it could also undermine the trust in vaccinations built up over the last century.
Riley explained that the third phase of a vaccine trial is designed to assess effectiveness of a new vaccine and to identify adverse effects that were not picked up in a study’s first and second phases.
“Phase 3 trials involve a large number of volunteers, which enable the trials to detect adverse events that are relatively rare,” Riley said, noting that this number is often in the thousands. “If such events are detected after a vaccine goes to market, the vaccine will have to be withdrawn.”
When asked on ABC’s Good Morning America about the news Tuesday, U.S. Health and Human Services Secretary Alex Azar said he did not see vaccine registration as a rat race.
“The point is not to be first with a vaccine,” Azar said. “The point is to have a vaccine that is safe and effective for the American people and the people of the world.”
Compared with the U.S., which has seen more than 5 million cases and has the highest death and case count in the world with more than 163,000 fatalities, Russia has confirmed around 898,000 cases and 15,000 deaths.
Azar noted that the U.S. currently has six vaccine candidates thanks to its Operation Warp Speed initiative. He also touted the importance of having transparent data that supports a vaccine’s efficacy and safety before approving it for widespread use. Globally, around 165 vaccines have been developed — around 30 of these are in various stages of human trial testing.
Referencing the former Soviet Union’s coordination with the U.S. on space exploration, Kirill Dmitriyev, CEO of the $10 billion sovereign wealth fund that financed the vaccine, urged other countries to come knocking on Russia’s door if they’d like to “provide their citizens in the near future with a high-quality and safe drug that actually saves lives and can halt the pandemic.”
Dmitriyev said the third phase of the Sputnik V trials would begin Wednesday, involving an international subject pool with thousands of participants from United Arab Emirates, Saudi Arabia, the Philippines and Brazil. Russian authorities have promised that high-risk groups like medical workers and teachers will have primary access to the first vaccines.
Berkeley’s professor Riley suggested that Russia could be putting those who receive the vaccine at risk.
“The concern is whether this vaccine can induce a strong enough antibody response that can neutralize the coronavirus if someone gets naturally infected,” Riley explained. “If the antibody response is not high enough, it won’t be protective, or it can even cause the infection to get worse.”
Industrial production of the vaccine is projected for September, said Dmitriyev, adding that the country has already received “applications for over one billion doses” from 20 countries. In coordination with its foreign partners, Russia could manufacture 500 million doses of vaccine per year in five countries, Dmitriyev continued, denouncing media criticism in other countries of the vaccine.
Some Russian scientists, however, are among those critical of the early rollout.
“Fast-tracked approval will not make Russia the leader in the (vaccine) race, it will just expose consumers of the vaccine to unnecessary danger,” Russia’s Association of Clinical Trials Organizations said in a letter sent to Health Minister Mikhail Murashko on Monday, in which it pushed Russian officials to postpone the vaccine’s approval until it had completed the recommended trials.
According to Bloomberg News, ACTO Executive Director Svetlana Zavidova questioned the action Monday.
“Why are all corporations following the rules, but Russian ones aren’t? The rules for conducting clinical trials are written in blood. They can’t be violated,” Zavidova said. “This is a Pandora’s Box and we don’t know what will happen to people injected with an unproven vaccine.”
The Gamaleya Institute developed the vaccine by adapting a common cold-causing adenovirus to carry genes for a protein that coats the coronavirus — a method other vaccine candidates are also using, such as those by China’s CanSino Biologics as well as Britain’s Oxford University and AstraZeneca.
Riley warned that these candidates would be in trouble if there is a problem with Sputnik V’s rollout in Russia.
“Any adverse event reported with the Russian vaccine will have a serious impact on other vaccines based on a similar vaccine formulation,” he said.
Russia’s Health Ministry said in a statement Tuesday that it expects the vaccine to provide immunity from Covid-19 for up to two years based on other vector vaccine data.
The U.S., Britain and Canada in July accused Russian hackers of stealing vaccine research in the country’s haste to establish the world’s first Covid-19 vaccine and claim the national prestige that comes with it.