11 August 2020
BY NSIKAN AKPA National Geographic
CONCOCTING A VACCINE is not the same thing as proving a vaccine is safe and effective. That’s Anthony Fauci’s take on the news out of Moscow that Russia has approved and is ready to market a coronavirus vaccine.
Fauci, the director of the U.S. National Institute of Allergy and Infectious Diseases, made the comments as part of a keynote interview for Stopping Pandemics, an exclusive event due to air August 13 via National Geographic.
“I hope that the Russians have actually definitively proven that the vaccine is safe and effective,” Fauci said to ABC News correspondent Deborah Roberts, who is moderating the event. “I seriously doubt that they've done that.”
Russia has hinted all summer that it’s progressing quickly on its vaccine candidate, which is named Sputnik V after the nation’s groundbreaking satellite launched in 1960. In May, the director of the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, where the vaccine is being developed, said he and other researchers had begun testing the drug on themselves before the first phase of human trials began with 76 subjects a month later.
But Gamaleya has yet to publish any results from human trials, which typically involve three phases to check a drug’s safety, efficacy, and dosage. The institute also has not released any preclinical research involving animal models or experiments with cells raised in petri dishes. (Dozens of COVID-19 vaccines are in development—here are the ones to follow.)
Despite this dearth of public information, Russian president Vladimir Putin says that the country’s health regulator is ready to approve the vaccine for widespread use. “We have to be grateful to those who have taken this first, very important step, very important for Russia and for the entire world,” Putin said in a statement released today by the Kremlin.
The approval comes even though other Russian officials say that phase three trials are still ongoing. Kirill Dmitriev, chief executive of the Russian Direct Investment Fund that is financing the vaccine, told the Associated Press that these advanced trials had been scheduled to begin August 12 across several countries, including Russia, Saudi Arabia, the United Arab Emirates, the Philippines, and possibly Brazil. But the AP could find no documentation in the Russian Health Ministry’s records citing these trials had been approved.
Phase three trials are crucial for validating if a vaccine is ready for wide distribution. This final step in testing is designed to pinpoint the safest dose for the mass public—a determination that can only be made by giving the vaccine to a diverse group of thousands of people. This stage of vaccine development also determines the degree to which a vaccine works.
According to a 2018 study by Massachusetts Institute of Technology, one in three vaccines make it through phase three trials—establishing a recommended dosage, and meeting established standards for safety and efficacy. The U.S. Food and Drug Administration has stated it will only approve a coronavirus vaccine if it has at least 50 percent efficacy.
“We have half a dozen or more vaccines,” Fauci told Roberts. “So if we wanted to take the chance of hurting a lot of people or giving them something that doesn't work, we could start doing this, you know, next week if we wanted to. But that's not the way it works.”
During the chat, the NIAID director also remarked on his pandemic expectations for the autumn and offered tips for how schools can safely reopen. Overall, Fauci is not pleased with the nation’s trajectory, given the country has now surpassed five million cases and more than 160,000 deaths. He is also disappointed by the vitriol being directed at him and other public health researchers. Fauci, who became NIAID director in 1984, says today’s backlash far surpasses anything he experienced during the politically heated days of the HIV pandemic in the early 1980s.
In response to his guidance about COVID-19, people are threatening his life, and they “terribly harass my wife and my children with phone calls,” Fauci told Roberts. “It seems inconceivable … that when you're trying to promote public health principles to save people's lives and keep them healthy, that there's such divisiveness in the country that that's interpreted to be so far from your own way of thinking that you actually want to threaten the person.”