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Vaccination can be harmful because it has not been tested in giant trials, researchers say
Russian President Vladimir Putin announced on August 11 that the country’s fitness regulator was the first globally to approve a coronavirus vaccine for widespread use; yet scientists around the world have condemned the resolution as dangerously hasty. Russia has not conducted large-scale trials to verify its protection and effectiveness, and the deployment of a poorly controlled vaccine can endanger those who receive it, according to the researchers. This can also hamper global efforts to expand quality vaccines opposed to COVID-19, they suggest.
“The fact that the Russians skip such measures and steps is what concerns our vaccine community. If they’re wrong, they can undermine the entire global enterprise,” says Peter Hotez, a vaccine specialist at Baylor College of Medicine in Houston, Texas. .
“This is a reckless and pointless decision. Mass vaccination with a poorly proven vaccine is unethical. Anyone with the Russian vaccination crusade would be disastrous, either because of its negative effects on fitness, but also because it would further delay the acceptance of vaccines in the population,” said Francois Balloux, a geneticist at University College London, in a distributed statement. uk Science Media Center.
In his announcement, Putin said the Russian regulator had approved a COVID-19 vaccine developed through the Gamaleya Institute for Epidemiology and Microbiology Research in Moscow, even though phase III trials of the vaccine had not yet been completed. These trials involve giving thousands of people a vaccine or placebo injection and then following them to see if the vaccine prevents the disease. They also allow researchers to verify vaccine protection and look for rarer side effects that may not have been observed in smaller previous trials. Russian Health Minister Mikhail Murashko said the vaccine will be gradually distributed to citizens and administered first to fitness staff and teachers.
More than two hundred COVID-19 vaccines are being developed internationally and several are already in Phase III trials, and more pioneers are expected to start with their own soon. But the researchers said the first of those vaccines could be approved in a few months.
The Gamaleya vaccine was administered to 76 volunteers in two initial trials in ClinicalTrials.gov; however, no effects of these trials or other preclinical studies have been published and little is known about the experimental vaccine.
According to ClinicalTrials.gov lists, the vaccine, administered in two doses, is composed of two adenoviruses that explicit the complex protein of coronavirus. The first dose is an Ad26 virus – the same strain is used in an experimental vaccine in progression through the pharmaceutical company Johnson and Johnson and its subsidiary Janssen – while the moment dose of “recovery” is made of an Ad5 virus, like that of an experimental virus. puncture in CanSino Biologics progression in China.
According to the Russian vaccine registration certificate, the 38 participants who won one or two doses of the vaccine had produced antibodies opposite the complex SARS-CoV-2 protein, adding resistant neutralizing antibodies that inactivate the viral particles. These effects are due to the effects of initial trials of other candidate vaccines. Side effects such as fever, headache and skin inflammation were also occurred at the injection site.
Hotez hopes the Gamaleya vaccine will cause a decent immune reaction opposite SARS-CoV-2. “The technical prowess of creating a COVID19 vaccine is not very complicated,” he says. “The most complicated component is to generate those vaccines under quality umbrellas – quality control and quality assurance – and then make sure that the vaccines are safe and that they oppose COVID19 in giant Phase III clinical trials.”
But little is known about the Plans of the Phase III trial for the Gamaleya vaccine. “I just couldn’t locate the main published points of a protocol,” says Danny Altmann, an immunologist at Imperial College London. It expects the trial to largely monitor participants’ immune responses and observe side effects.
The director of a Russian government-backed investment fund said the vaccine would pass through Phase III testing in the United Arab Emirates, Saudi Arabia and other countries, according to Russian state news firm TASS. The official said that requests for acquisition of one billion doses have been earned from 20 countries in Latin America, the Middle East, Asia and elsewhere, and that production is in a position to produce 500 million doses, with more capacity underway.
Altmann expressed fear that the vaccine may simply cause an aggravated disease that occurs when antibodies generated through the vaccine carry the virus to cells after exposure to the virus. Another challenge may simply be an asthma-like immune reaction that has a challenge with some experimental vaccines opposed to SARS virus (severe acute respiratory syndrome). To stumble upon these reactions, thousands of others who have won a vaccine or placebo and are potentially exposed to SARS-CoV-2 deserve to be compared.
“It is absolutely ridiculous to get permission on this data,” says Svetlana Zavidova, director of the Russian Association of Clinical Trial Organizations, which works with foreign pharmaceutical corporations and research organizations. Without a Phase III trial completed, Zavidova also fears that it will be transparent if the vaccine prevents COVID-19 or, or causes destructive effects, due to gaps in the way Russia monitors the effects of drugs. “Our security tracking system, I think, is the best,” he says.
Zavidova is also involved in the vaccine’s approval being “very harmful” to efforts to conduct clinical trials of other COVID-19 vaccines and other medicines in Russia.
“I don’t know what Russia is doing, but in fact I wouldn’t take a vaccine that hasn’t been tested in Phase III,” said Florian Krammer, an immunologist at Icahn School of Medicine in Mount Sinai, New York, in a Pio. “No one knows if it is or if it works. They put [health workers] and their population at risk.”
This article is reproduced with permission and was first published on August 11, 2020.
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