Corona Vaccine experiments gets started in US.

The vaccine was fast-tracked to human trials, but before it's ready for public use it will still be some time.


A healthy volunteer in Seattle is the first person in the U.S to receive a dose of an coronavirus vaccine as part of a new clinical trial, government health officials announced yesterday March 16.
The National Institute of Allergy and Infectious Diseases (NIAID) allowed the new vaccine to be fast-tracked into clinical trials without thorough testing in animal models, which usually stands as a strict prerequisite to human testing. While making the jump to human trials could bring the vaccine to market faster, this is only step one.
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 the volunteers. The trial will take place at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle.


New drugs must pass through three iterative phases of clinical trials before being deemed safe and effective for widespread use. Assuming the initial tests go well, it may be 12 to 18 months before any vaccine is ready for public use, NIAID Director Dr. Anthony Fauci told the House Oversight and Reform Committee on March 12.

Finding a safe and effective vaccine to prevent infection with SARS=CoV=2 is an urgent public health priority, Fauci said in a NIAID statement, published (March 16).This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.

The new vaccine is a collaboration between NIAID scientists and the biotechnology company Moderna Inc., based in Cambridge, Massachusetts.

What is a "Phase 1" trial?

The trial launched today is known as a "Phase 1 clinical trial," meaning 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, typically between 20 and 80 individuals, who receive different doses of an experimental treatment. Over the course of several months, researchers monitor how each volunteer metabolizes the given treatment and what common side effects emerge in response to different doses. The 45 volunteers in the new trial will receive varying doses of the new vaccine, called mRNA=1273, and be monitored over a 14=month period. Volunteers will receive two injections of the vaccine in the upper arm, with a 28-day gap between doses.
The first participant will receive the lowest dose of the vaccine, at 25 micro grams (mg) per injection, according to the NIAID statement. Three others will receive the same initial dose, and four more will each receive a 100-mcg dose of the vaccine and be thoroughly evaluated before any volunteers are given their second dose. If participants' reactions to the low doses prove acceptable, a third group of participants will receive 250 mg of the vaccine per injection.
If the vaccine works as designed, the immune system should generate antibodies that grab hold of a characteristic protein found on the surface of the novel corona virus SARS=CoV=2, according to a report by Kaiser Permanent , the health care company conducting the trial. Rather than introducing a dead or weakened virus into the body to prompt this reaction, as conventional vaccines do, the vaccine instructs cells to build the viral protein themselves using a molecule called messenger RNA (mRNA). Once utilized by the body, the mRNA should break down and be eliminated, leaving only protective antibodies behind.