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In the phase 1 study, the researchers will test three different doses of the mRNA-1273 vaccine.
The first human trail of an experimental vaccine for the new coronavirus began Monday in the US. A woman received the first shot of the vaccine in the first-stage clinical trial at the Kaiser Permanente Washington Health Research Institute in Seattle.
The vaccine, mRNA-1273, was developed by biotechnology company Moderna in combination with researchers from the National Institutes of Health (NIH). Once the vaccine is found to be safe, the researchers will determine how well it works in later studies.
In the phase 1 study, the researchers will test three different doses of the mRNA-1273 vaccine. They will enrol 45 healthy adults ages 18 to 55 for the initial trial. Each participant will receive two shots, 28 days apart. They will be monitored to evaluate both the safety and immunogenicity of the vaccine.
The researchers hope that the vaccine will stimulate the immune system to make antibodies that can stop the coronavirus from replicating and prevent development of COVID-19.
The first vaccine shot was given to Jennifer Haller, a 43-year-old woman from Seattle. Total four participants were vaccinated on Monday. Four more will get shots on Tuesday.
Even if the vaccine is proved safe and effective against the new coronavirus, it will not be available for at least a year. The study participants will be followed for 12 months after the second vaccination. It will take considerable time to collect the data and figure out whether it is safe and effective.
However, the researchers may get the safety data a few weeks after the injections were given. If the vaccine is found safe, the company will seek permission from the Food and Drug Administration to move ahead to the next phase of testing. The second round of testing will involve more participants. It will be done to measure efficacy of the vaccine and verify its safety.
Researchers at Moderna began work on the vaccine in January, immediately after Chinese scientists posted the genetic sequence of the SARS-CoV2 coronavirus on the internet.
U.S. researchers began the first human trial of a #coronavirus vaccine
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The vaccine was not tested in mice before beginning human clinical trials. This has raised concern among many experts.
While some experts say it is justified considering the severity and urgent need of the current situation, others fear that this could break various ethical and safety standards. They are also concerned that such immediate trial could put participants at greater risk.
While mRNA-1273 is the first vaccine to reach a clinical trial, many other companies are also using different approaches to manufacture coronavirus vaccines.
Israel's state-funded Migal Galilee Research Institute has also developed an oral vaccine for coronavirus. Clinical testing of the vaccine is expected soon. The researchers claimed that the oral vaccine could turn COVID-19 into a very mild cold.
In the US, a biotech firm is conducting clinical trial of the antiviral medicine remdesivir on Covid-19 patients.
Meanwhile, doctors in many countries are using also a combination of two anti-HIV drugs to treat coronavirus patients. The Drug Controller General of India has also approved restricted application of lopinavir and ritonavir for treating COVID-19 patients.