‘I would like to see the data’: Experts skeptical of Russian COVID-19 vaccine
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Russian President Vladimir Putin said Tuesday that his country has approved a COVID-19 vaccine, apparently without completing clinical trials to fully test its safety and efficacy, according to multiple news reports.
On Russian state TV, Putin said the vaccine “works quite effectively” and “forms stable immunity,” CNN reported.
Source: Official White House Photo by Shealah Craighead
Former FDA Commissioner Scott Gottlieb told CNBC that he would not take the vaccine outside of a clinical trial because “it appears it’s only been tested in several hundred patients at most.” A vaccine at this stage of development — “effectively a phase 1 trial” — would not be approved in the U.S., Gottlieb said.
“You wouldn’t want to take that outside of a clinical trial where you’re being closely monitored,” he said. “In a lot of these situations, you might only get one shot at taking a vaccine within a season, so if you put a vaccine on the market that’s not efficacious, it’s going to be hard to revaccinate the population. You want to make sure it works, and you also want to make sure it’s safe.”
More than 20 million cases of COVID-19 have been reported globally, including more than 5 million in the U.S. Russia has reported just under 900,000 cases, according to tracking by Johns Hopkins University.
Other vaccine efforts have been more open. Last month, researchers published encouraging early-stage data on three vaccine candidates, including one being developed by the NIH and Moderna Inc., the first U.S. COVID-19 vaccine to enter phase 3 trials. Two vaccine candidates in development at Oxford University in the U.K. and in Wuhan, China, also have produced encouraging results in early-stage trials.
According to reports, Putin said one of his daughters has already taken the Russian vaccine, which is named “Sputnik V” — a reference to the Russian-launched satellite that ignited the space race in the 1950s.
“This approach is counter to the one that we are using in the United States,” Kathryn Edwards, MD, director of the Vanderbilt Vaccine Research Program, told Healio. “Here data are being released on each vaccine and they are being submitted to peer-reviewed journals where scientists can review and critique the studies. Then large efficacy studies are being done to assure that the vaccines are safe and effective. If they are shown to be at least 50% then they will be licensed. This seems like the safest and most reasonable approach.”
The Russian vaccine, which was developed by the Gamaleya Research Institute, is a “technically complex” adenovirus vector vaccine rather than a protein-based vaccine, meaning more can go wrong from a technical standpoint during development, Gottlieb said.
“I would like to see the data on the safety and the immunogenicity of the vaccine that was licensed,” Edwards said. “Also, it would be helpful to see if the vaccine protects nonhuman primates from disease with no vaccine-induced enhancement. Finally, did the vaccine work to protect individuals from COVID-19 disease?”
Peter J. Hotez, MD, PhD, co-director of the Texas Children’s Hospital Center for Vaccine Development, said it is scientifically inaccurate to describe the Russian announcement as being part of “a race” to develop a COVID-19 vaccine because of the concerns that it skipped the steps necessary to ensure the vaccine is effective and safe.
“My other worry is that the Russians will export a vaccine that is either untested or undertested to countries in Africa or in Latin America — Cuba, Nicaragua, Venezuela — as a means to exert old-fashioned ‘Cold War’ style political influence,” Hotez tweeted. “The dark side of vaccine diplomacy.”
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