COVID-19 – Day 120: First Trial of COVID-19 Vaccine with Humans

MODERNA

(E) It goes without saying that some of the best biotech firms and researchers are working no stop to find a vaccine against the COVID-19 virus.  Today, Moderna , a biotech company based in Boston, is testing its mRNA-1273 vaccine on humans.

Moderna has developed its mRNA technology platform that “functions like an operating system on a computer. It is designed so that it can plug and play interchangeably with different programs. In our case, the “program” or “app” is our mRNA drug – the unique mRNA sequence that codes for a protein.”

Following is the timeline of their mRNA-1273 pioneering vaccine work:

  • “On January 11, 2020, the Chinese authorities shared the genetic sequence of the novel coronavirus.
  • On January 13, 2020, the U.S. National Institutes of Health (NIH) and Moderna’s infectious disease research team finalized the sequence for mRNA-1273, the Company’s vaccine against the novel coronavirus. At that time, the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, disclosed their intent to run a Phase 1 study using the mRNA-1273 vaccine in response to the coronavirus threat and Moderna mobilized toward clinical manufacture. Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
  • On February 7, 2020, the first clinical batch, including fill and finishing of vials, was completed, a total of 25 days from sequence selection to vaccine manufacture. The batch then proceeded to analytical testing for release.
  • On February 24, 2020, the clinical batch was shipped from Moderna to the NIH for use in their Phase 1 clinical study.
  • On March 4, 2020, the U.S. Food and Drug Administration (FDA) completed its review of the Investigational New Drug (IND) application filed by the NIH for mRNA-1273 and allowed to the study to proceed to begin clinical trials.
  • On March 16, 2020, the NIH announced that the first participant in its Phase 1 study for mRNA-1273 was dosed, a total of 63 days from sequence selection to first human dosing.

This Phase 1 study will provide important data on the safety and immunogenicity of mRNA-1273. Immunogenicity means the ability of the vaccine to induce an immune response in participants. The open-label trial is expected to enroll 45 healthy adult volunteers ages 18 to 55 years over approximately six weeks.”

Note: The picture above is a vaccination.

Copyright © 2005-2020 by Serge-Paul Carrasco. All rights reserved.
Contact Us: asvinsider at gmail dot com

Categories: Coronavirus