Russian President Vladimir Putin announced Tuesday that the country’s health care regulator had approved a coronavirus vaccine for use, Reports Nature News.
Although this makes Russia the first country to do so, the experimental vaccine has not been tested in complex clinical trials, which are necessary to determine whether the vaccine is safe and effective.
“This announcement breaks all the guiding principles you’d like to have on the table to ensure a vaccine that maintains public confidence,” said Dr. Jon Andrus, assistant professor of global vaccination and vaccine policy at the Milken School of Public Health School at George University in Washington.
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, adding the Russian vaccine, and 139 are in the preclinical stage, which includes animal testing, according to the World Health Organization.
Five of these applicants are in Phase 3 trials, adding one from the modern biotechnology company, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID); University of Oxford and AstraZeneca.
Most of the vaccines that completed the first clinical trials showed promising results. But they have not yet been tested as opposed to placebo in large-scale trials, which would show whether the vaccine is effective.
Many vaccine experts doubt that the U.S. will see a coronavirus vaccine approved on Election Day, which President Donald Trump said “optimistic.”
The Russian candidate vaccine was administered to a small number of volunteers in phase 1 and phase 2 clinical trials.
These effects are those observed with initial 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 barriers to a COVID-19 candidate vaccine that produces neutralizing antibodies “are not very high.”
This would require a Phase 3 test, involving thousands of volunteers. During these tests, researchers are the candidate vaccine for an inactive placebo.
This later-stage trial is the only way to know with statistical certainty whether a vaccine protects others from infection or reduces the severity of the disease.
These tests may also identify side effects that may have been overlooked or not detected in previous tests.
This is a harmful condition called “antibody-dependent enhancement” or EAD, in which a vaccinated user shows more severe symptoms when exposed to the vaccine-oriented virus.
This has been observed with vaccines, an evolved dengue.
Another prospective-looking effect is an asthma-like immune reaction that has occurred with some experimental SARS vaccines, caused by a similar coronavirus.
To identify these less common but serious types of side effects, the vaccine or placebo should be given to thousands or tens of thousands of people.
“You may or may not see protection issues in your phase 1 or 2 clinical studies,” Andrus said. “At the end of the day, you want more numbers.”
That’s why the Centers for Disease Control and Prevention continues to monitor vaccine protection after approval.
“As you vaccinate more people, you’ll start to see rarer side effects,” Andrus said.
All vaccines, medicines and remedies carry safe risks. Doing Phase 3 studies and continuous tracking provides a broader concept of what it is.
“If an adverse opportunity arises from the vaccine, but is overcome by the benefits that the vaccine gives to save lives, then the voice of explanation of why he would say yes, we use the vaccine, because the threat of this adverse occasion is so rare,” Says Andrus.
Others are concerned that Russia’s willingness to approve its vaccine may have repercussions in other countries.
“However, the fear is that the White House sees this as a kind of “arms race” and will use it as an excuse to try and promote a vaccine opposed to the speed of Operation Warp before the fall election,” Hotez wrote on Twitter. , in reference to the Trump administration’s coronavirus immunization program.
Andrus says that while recent advances in genetic sequencing and other technologies have allowed scientists to expand COVID-19 candidate vaccines more quickly, there are limits to the rate at which a Phase 3 test can be run.
“The speed of distortion means we can take shortcuts when it comes to safety,” he said, “and we don’t need to do that.”
To warn against accelerated clinical trials, it highlights disorders with a vaccine developed in 1976 for a new form of influenza.
U.S. President Gerald Ford pushed for the advancement of a flu vaccine, which public fitness experts first believed was very similar to the strain that caused the 1918 influenza 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 feared never materialized and the virus differed genetically from the pandemic influenza of 1918. In addition, of the forty-five million Americans vaccinated, more than forty-five other people have developed rare Guillain-Barré syndrome, which can cause paralysis.
FDA Commissioner Dr. Stephen Hahn said in a briefing monday that the firm will “take shortcuts” to determine the protection of a possible coronavirus vaccine.
He also stated that “it is possible” to have a vaccine in the United States before the end of 2020.
However, Dr. Anthony Fauci, Director of NIAID, hopes that early 2021 will be a more likely timeline, assuming that recently conducted Phase 3 clinical trials are successful.
Andrus, however, warns that there is no guarantee that one day we will have an effective coronavirus vaccine for COVID-19.
“We’ve been working for decades with a vaccine against HIV, respiratory syncytial virus (RSV) and other deadly diseases, and we’ve still done that,” he said.
He adds that any vaccine opposed to coronavirus, if successful, will also have to be used in conjunction with other public fitness measures known to the paintings: physical remoteness, dressing in masks, self-insulating other people in disrepair, and washing their hands normally.
“We don’t know how effective a coronavirus vaccine will be. We don’t know how the source will be obtained when deployed. And it may not be available to everyone on the first day,” he said. “So when a vaccine is available, it will have to be incorporated into those approaches.”
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