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Tags Current Affairs

Experimental coronavirus vaccine

Date: 17 March 2020 Tags: Biotechnology

Issue

A healthy volunteer is the first person in the U.S. to receive a dose of an experimental coronavirus vaccine as part of a new clinical trial.

 

Background

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.

 

Details

  • 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.

  • 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.

  • The trial 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.

  • 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.

  • In addition to monitoring for side effects, the researchers will test whether the vaccine triggers an immune response by analyzing the volunteers' blood for antibodies.

  • 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 coronavirus SARS-CoV-2.

  • 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).

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