News: First person in the U.S. receives a dose of an experimental COVID-19 vaccine.
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This is great news for the scientific community! A healthy Seattle volunteer is the first person in the United States to receive a dose of an experimental coronavirus vaccine in a new clinical trial, government health officials announced today, Monday, March 16, 2020.
Expedited research:
The National Institute of Allergy and Infectious Diseases (NIAID) has allowed the new vaccine to enter clinical trials more quickly without extensive animal testing, which is usually a strict prerequisite for human trials. While the move to human trials may speed the vaccine to market, it is only the first step.
The testing phase has begun:
The vaccine has undergone accelerated human trials, but it will be some time before it is ready for public use.
Over the next six weeks, researchers plan to enroll 45 participants in the trial, which will test the safety of the vaccine as well as its ability to induce an immune response in volunteers. The trial will take place at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.
When will this vaccine be ready for distribution?
New drugs must go through three iterative phases of clinical trials before they are deemed safe and effective for widespread use. Assuming the initial tests go well, it could take 12 to 18 months before a vaccine is ready for public use, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), told the House Oversight and Reform Committee.
"Finding a safe and effective vaccine to prevent the virus is an urgent public health priority," Dr. Fauci said in a NIAID statement released March 16. "This Phase 1 study, launched in record time, is an important first step toward achieving that goal."
The new vaccine is the result of a collaboration between NIAID scientists and the Cambridge, Massachusetts-based biotechnology company Moderna Inc.
What is a "phase 1" trial?
The trial launched this week is a Phase 1 clinical trial, which means its main purpose is to provide information about how the vaccine interacts with a healthy human body, according to the U.S. Food and Drug Administration (FDA).
Phase 1 trials examine a small group of people, usually between 20 and 80 individuals, who receive different doses of an experimental treatment. Over several months, researchers monitor how each volunteer metabolizes the given treatment and what common side effects occur in response to the different doses. The 45 volunteers in the new trial will receive varying doses of the new vaccine, called mRNA-1273, and will be followed for a period of 14 months. Volunteers will receive two injections of the vaccine in the upper arm, with a 28-day interval between doses.
The first participant will receive the lowest dose of the vaccine, 25 micrograms (mcg) per injection, according to the NIAID statement. Three other participants will receive the same initial dose, and four more will each receive a 100-microgram dose of vaccine and undergo further evaluation before the volunteers receive their second dose. If participants' responses to the low doses prove acceptable, a third group of participants will receive 250 mcg of the vaccine per injection.
In addition to monitoring for side effects, researchers will test whether the vaccine triggers an immune response by testing volunteers' blood for antibodies.
Next steps:
After the phase 1 trial of the experimental vaccine, the drug must then be tested in larger groups of people and over longer periods of time in phase 2 and phase 3 trials, according to the U.S. Centers for Disease Control and Prevention (CDC).
Phase 2 trials typically examine several hundred people and follow participants for periods ranging from several months to two years. Phase 2 trials serve primarily as a secondary measure of safety and help researchers refine the dosage of a particular drug. At this stage, researchers select participants whose characteristics, such as age and physical health, match those of the people for whom the vaccine is being developed. (For example, although anyone can get COVID-19, people of advanced age and those with chronic illnesses are more likely to develop severe symptoms, so this could be considered in Phase 2 trials.)
Phase 3 trials typically follow 300 to 3,000 volunteers over one to four years. With a larger group of people, researchers can take note of unusual side effects of the drug, and by extending the study period, they can detect long-term side effects as soon as they appear. Phase 3 trials must demonstrate that a given drug provides the intended medical benefit. If this coronavirus vaccine passes this test, the FDA could approve the drug for widespread use.
Once approved by the FDA, drugs undergo phase 4 clinical trials, also known as "post-marketing surveillance trials." Once a drug enters the public domain, researchers monitor several thousand volunteers for side effects not seen in previous trials and to track the vaccine's effectiveness over extended periods, according to the National Cancer Institute.
This coronavirus vaccine may or may not reach Phase 4 trials, although so far limited studies in mice have shown promising results. Meanwhile, research groups around the world will continue to develop other vaccines to combat the spread of COVID-19.
Sources : Livescience
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