Vladimir Putin’s announcement that Russia has approved the world’s first coronavirus vaccine has unleashed a stream of skepticism and criticism from Western scientists.
The Russian president said on Tuesday that health authorities have approved a vaccine developed by the Gamaleya Institute and that his own daughter had been inoculated with it. According to the Russian Health Ministry, the vaccine will be made available to medical workers, teachers and at-risk groups already this month, while widespread vaccinations could get underway by October.
The Russian authorities acknowledged that the vaccine has not yet undergone widespread Phase 3 testing but Putin insisted it is safe and that further testing will continue.
“What counts most is for us to be able to ensure the unconditional safety of the use of this vaccine and its efficiency in the future. I hope that this will be accomplished,” he said on Tuesday.
‘Reckless and foolish’
According to reports, the Gamaleya vaccine has only been administered to 76 volunteers. The US National Institutes of Health’s ClinicalTrials.gov database includes no results from the Gamaleya trials but said the two-dose vaccine consists of two adenoviruses, the Ad26 virus and the Ad5 virus, that produce antibodies against the spike protein of the novel coronavirus.
Almost immediately after Putin’s announcement on Tuesday, skeptics sounded the alarm about the vaccine’s contracted timeline and expressed concerns that the vaccine, dubbed Sputnik V, was being rushed in order to give the Russian president a geopolitical victory.
Scientists cautioned that the decision to roll out the vaccine so quickly could not only endanger those who take it but might also set back global efforts to develop a higher-quality, more thoroughly-vetted vaccines to fight the COVID-19 pandemic.
“This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical,” Francois Balloux, a geneticist at University College London, 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.”
Balloux’s remarks were included in a collection of statements distributed by the UK Science Media Centre. Many of the scientists included in the round-up said that there is simply not enough known about the Russian vaccine at this point.
“It is unclear precisely what is actually happening with the Russian vaccine. It is vital that any vaccine roll-out has the confidence of the general public, and that there is good communication of the level of effectiveness and any likely side effects,” Michael Head, a senior research fellow at the University of Southhampton, said. “At this point in time, there is no data on the Russian-led vaccine for the global health community to scrutinize.”
‘Not being very transparent’
Some Western governments were also quick to express skepticism. German Health Minister Jens Spahn said in a radio interview that “the problem is that we know very little because the Russian authorities are not being very transparent.”
“It can be dangerous to start vaccinating millions, if not billions of people too early because that would likely kill off the [public] acceptance of vaccination if it goes wrong. So I’m very skeptical about what’s happening in Russia,” Spahn told Deutschlandfunk, according to the Financial Times.
US Health and Human Services Secretary Alex Azar told ABC News that Russia has not yet proven its claims.
“We need transparent data, and it’s got to be phase three data, that shows that a vaccine is safe and effective,” he said.
The World Health Organization (WHO), which still officially lists the Gamaleya vaccine as being in Phase 1 of testing, has said that it is in discussions with Russian health authorities to discuss prequalification for the vaccine.
“We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine, but again prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data,” WHO spokesman Tarik Jasarevic told a U.N. briefing in Geneva, according to Reuters.
Shortly after Putin’s announcement on Tuesday, Kirill Dmitriev, head of the Russian Direct Investment Fund that supports the Gamaleya project, told the Washington Post that the health authorities of 20 different countries have already applied for more than one billion doses of the vaccine.
On Wednesday, it was reported that the Brazilian state of Parana is already in talks with Russian authorities to begin production of the vaccine despite its questionable current status. This led Jarbas Barboas, the assistant director of the Pan American Health Organization, to caution against making such a move without Phase 2 and Phase 3 results.
“Any vaccine producer has to follow this procedure that guarantees it is safe and has the WHO’s recommendation,” he said in a virtual briefing from Washington, according to Al-Jazeera.
Peter Hotez, a vaccine scientist at the Baylor College of Medicine, warned that approving Sputnik V without full Phase 2 and Phase 3 results could affect the scores of other efforts underway to develop an effective vaccine against COVID-19, which as of Wednesday had infected over 20 million people and caused nearly 750,000 deaths.
“That the Russians may be skipping such measures and steps is what worries our community of vaccine scientists. If they get it wrong it could undermine the entire global enterprise,” he told the journal Nature.