“Russian President Vladimir Putin announced that his nation’s inoculation is safe for a mass audience, despite the fact that it has not yet finished its final round of testing.”

As the world races to develop a coronavirus vaccine, Russia declared victory on Tuesday. Although it has cleared a virus, named Sputnik-V, for public use, skeptics questioned the vaccine’s safety, CNBC reported.

“I wouldn’t take it, certainly not outside a clinical trial right now” said Dr. Scott Gottlieb, former Food and Drug Commissioner and CNBC contributor. “They’re claiming that it’s fully approved, but it’s not fully approved.” 

He added that Russia has yet to publish data from the drug’s trials.

“We certainly wouldn’t allow a vaccine to be used for mass distribution at this point based on the data we have at hand,” Gottlieb said. “We just don’t know if the vaccines are safe and effective at this point.” 

The former FDA commissioner wasn’t the only skeptic who questioned the vaccine’s safety, CNN reported.

“It is unclear precisely what is actually happening with the Russian vaccine,” said Michael Head, Senior Research Fellow in Global Health at the University of Southampton in the UK. “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. At this point in time, there is no data on the Russian-led vaccine for the global health community to scrutinize.”

America Is Keeping Pace

US Health and Human Services Secretary Alex Azar maintained that the priority is not to be the first to have a vaccine, but to have a candidate that is both safe and effective. For that to happen, vaccine candidates must clear phase three trials, which the Sputnik-V vaccine has not completed.

American companies are currently trialing two vaccines in phase three trials. Russian President Vladimir Putin announced that his nation’s inoculation is safe for a mass audience, despite the fact that it has not yet finished its final round of testing, POLITICO reported.

“I would like to repeat that it has passed all the necessary tests,” Putin said. “The most important thing is to ensure full safety of using the vaccine and its efficiency.”

The Russian leader is so confident of the vaccine that one of his daughters already received it. It was distributed in two parts, both of which caused her body temperature to spike up for one day.

“She’s feeling well and has high number of antibodies,” Putin said of his daughter.

Skipping A Step

Data from Russia’s Association of Clinical Trials Organizations indicates that fewer than 100 people have been injected with the vaccine, Bloomberg reported. The small scope of publicly-available research data suggests it may not be the silver bullet the world has been searching for.

“The bar is necessarily set very high for criteria that must be satisfied for approval after Phase 3 clinical trials,” said Danny Altmann, professor of immunology at Imperial College London. “The collateral damage from release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably. I hope these criteria have been followed. We are all in this together.”

In order to mitigate possible side effects in addition to assuring safety and efficiency, vaccines are tested in incremental steps. The first two phases typically include a maximum of 200 patients, Gottlieb said. Phase three trials are considered mass testing, which can involve tens of thousands of patients of different backgrounds. 

The Russian Health Ministry declared Sputnik-V can ensure immunity from COVID-19 for up to two years and Moscow is aiming for mass distribution as soon as October. The short time frame leaves little opportunity for a full analysis of phase three results. 

Putin Needs A Win

Skeptics questioning the vaccine’s safety suggested Putin could be eager to push out a virus to distract his nation from dismal recent events. The leader has faced protests over his removal of a governor in Eastern Russia and an economic downturn from COVID-19 and sunken oil prices.

Furthermore, Putin’s support continues to erode despite him successfully amending the constitution to allow him to seek more terms in office. For Putin, being first to deliver a vaccine could improve his political stature.

Moscow defended the rush and vaccine’s safety.

“According to the results, the vaccine has shown high efficiency and safety. All volunteers developed high [tiers] of antibodies to Covid-19, while none of them showed serious complications of immunization,” Russian Health Minister Mikhail Murashko said.

The Gamaleya Institute, which developed the vaccine, has already secured orders from Saudi Arabia, the United Arab Emirates as well as manufacturing agreements with South Korea, Brazil, and India.