- Russia approved its experimental coronavirus vaccine for widespread use, even before it has been tested in late-stage clinical trials, raising many concerns about safety.
- Experts say the approval “breaks every guiding principle” to ensure a safe and effective vaccine.
- Putin said that the coronavirus vaccine developed by Moscow-based Gamaleya Research Institute was approved for widespread use, in spite of it not having been tested in vital phase 3 clinical trials.
Russian President Vladimir Putin announced on Tuesday that the country’s healthcare regulator had approved a coronavirus vaccine for widespread use, reports
While this makes Russia the first country to do so, the experimental vaccine has not been tested in late-stage clinical trials, which are needed to know if the vaccine is safe and effective.
“This announcement breaks every guiding principle you would want to have on the table to ensure a safe vaccine that maintains public trust,” said Dr. Jon Andrus, adjunct professor of global vaccinology and vaccine policy at the Milken Institute School of Public Health of George Washington University.
No phase 3 trials
According to Nature, Putin said that the coronavirus vaccine developed by Moscow-based Gamaleya Research Institute was approved for widespread use, in spite of it not having been tested in phase 3 clinical trials.
Russian healthcare minister Mikhail Murashko said that the experimental vaccine would be given first to healthcare workers and teachers, and then gradually rolled out to the rest of the population.
Worldwide, 28 candidate vaccines are in clinical trials, including the Russian vaccine, with another 139 in preclinical stages, which includes animal testing,
Five of these candidates are in phase 3 trials, including one from biotechnology company Moderna, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID); and another from the University of Oxford and AstraZeneca.
Most of the vaccines that have completed early clinical trials have shown promising results. But they have not been tested yet against a placebo in widespread trials, which would show if the vaccine is safe and effective.
Many vaccine experts are doubtful that the United States will see a coronavirus vaccine approved by Election Day, something President Donald Trump has said he is “optimistic” about.
Too early to know if Russia vaccine works and is safe
Russia’s candidate vaccine was given to a small number of volunteers as part of phase 1 and phase 2 clinical trials.
These trials showed that people who received the vaccine produced neutralizing antibodies against the spike protein of SARS-CoV-2, the virus that causes COVID-19. The most common side effects were headache, fever, and pain at the site of injection.
These findings are similar to what was seen with early-stage trials of other candidate vaccines.
Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, wrote on Twitter that the technical hurdles to developing a candidate vaccine for COVID-19 that produces neutralizing antibodies are “not very high.”
“The hard part is making a vaccine that you know actually works and [is] safe in humans,” he wrote. “That takes time.”
This would require a phase 3 trial, which involves thousands of volunteers. During this testing, researchers compare the candidate vaccine to an inactive placebo.
This later-stage trial is the only way to know with statistical certainty whether a vaccine protects people against infection or reduces the severity of the illness.
These trials can also identify side effects that may have been missed or not detected in earlier testing.
This includes a dangerous condition called “
This has been seen with vaccines including one developed for Dengue fever.
Another potential adverse effect is an asthma-like immune reaction that occurred with certain experimental vaccines against SARS, which was caused by a similar coronavirus.
Identifying these types of less frequent, but serious, side effects requires giving the vaccine or a placebo to thousands or tens of thousands of people.
“You may or may not see safety concerns in your phase 1 or 2 clinical studies,” said Andrus. “The bottom line is you need larger numbers.”
This is also why the Centers for Disease Control and Prevention continues to
“As you get larger numbers of people vaccinated, you will then begin to see more rare side effects,” said Andrus.
All vaccines, medications, and treatments carry some risks. Doing phase 3 studies and ongoing monitoring provides a better idea of what those are.
“If an adverse event due to the vaccine is present, but is overwhelmed by the benefits that the vaccine provides in saving lives, then the voice of reason would say yes, let’s use the vaccine, because the risk of that adverse event is so rare,” said Andrus.
Later-stage clinical trials can’t be rushed
Others are concerned that Russia’s push to approve its vaccine could have ripple effects on other countries.
“Still another worry is that the White House will see this as an ‘arms race’ of sorts and use it as an excuse to try and push an Operation Warp Speed Vaccine ahead of the fall election,” wrote Hotez on Twitter, referring to the Trump administration’s coronavirus vaccine program.
Andrus says while recent advances in genetic sequencing and other technology have enabled scientists to develop candidate vaccines for COVID-19 more quickly, there are limits to how fast you can run a phase 3 trial.
“Warp speed implies that we may be cutting corners on safety,” he said, “and we don’t want to be doing that.”
As a warning against fast-tracking clinical trials, he points to the problems that occurred with a vaccine developed in 1976 for a novel form of influenza.
U.S. President Gerald Ford pushed for the development of a vaccine for this flu, which public health experts initially thought was closely related to the strain that caused the 1918 flu pandemic.
“At that time, President Ford and others involved had the best of intentions to fast-track vaccine development,” said Andrus. “But they did not consider all of the safety aspects.”
In the end, the pandemic that some people feared never materialized, and the virus was found to be genetically distinct from the 1918 pandemic flu. In addition, of the 45 million Americans vaccinated, over 450 people developed the rare Guillain-Barré syndrome, which can cause paralysis.
FDA commissioner Dr. Stephen Hahn said in a briefing on Monday that the agency “will not cut corners” in determining the safety of a potential coronavirus vaccine.
He also said “it’s possible” that a vaccine could be available in the United States before the end of 2020.
However, Dr. Anthony Fauci, director of the NIAID, expects early 2021 is a more likely timeline — and that’s assuming the phase 3 clinical trials currently in progress are successful.
Andrus, however, cautions that there is no guarantee that we will ever have an effective vaccine for the coronavirus that causes COVID-19.
“We’ve been working for decades on a vaccine for HIV, respiratory syncytial virus (RSV), and other diseases that kill, and we have yet to be successful,” he said.
He adds that any coronavirus vaccine, if successful, also needs to be used alongside other public health measures that are known to work — physical distancing, wearing masks, self-isolation of sick people, and regular handwashing.
“We don’t know what the efficacy of a coronavirus vaccine is going to be. We don’t know what the supply availability will be when it’s rolled out. And it won’t be available for everybody on day one,” he said. “So when a vaccine becomes available, it has to be integrated with these approaches.”
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