View Single Post
Old 17 March 2020, 11:09 AM   #2330
BNABOD
"TRF" Member
 
BNABOD's Avatar
 
Join Date: Sep 2013
Location: USA
Posts: 663
Quote:
Originally Posted by 77T View Post
Moderna is the outfit who is first mover on the US vaccine. They are using Messenger RNA tech to engineer a vaccine.

Rather fast timeframe - I hope the first recipient has positive outcome for the purpose of testing safety. They hit NIH & FDA fastrack process ahead of all others.

Here’s a bit about the timeline of Moderna’s response and a link:

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.

https://www.modernatx.com/modernas-w...ainst-covid-19


Sent from my iPhone using Tapatalk Pro


Thanks and for anyone that does not know how this works (my wife is in the industry) this is very fast and about time the fda cut down some red tape. Now it will take time to go through the data from a safety and efficacy stand point but if it all goes well then let’s just pray it gets out there ASAP and that this virus doesn’t mutate for the worse .
BNABOD is offline