Originally Posted by
OpMidClimax
Steps for j and j..
1.. refine lead antigen to promote immunological response.
2.. finalize formula and delivery platform
2.. perform carc and mutagenic studies
2.. Perform animal clinical studies
September
3... phase 1 in human clinical study.. small scale
3.. manufacturing and engineering studies
3.. compile data, submissions to FDA
3.. laboratory work
December or January
4.. initiate phase 2a and 2b in human clinical studies... large scale
4... finalize final formula and delivery platform
4.. stability and shipping studies.
4.. manufacturing
4... laboratory work..
4.. compile data and submit to fda.
Maybe next year sometime
5. Large scale phase 3 concurrent with limited approval..
.. this would be how much of the population will start receiving the vaccine ahead of a formal approval.
5.. manufacturing
5... laboratory work..
5.. compile data and submit to fda.
6.. final FDA approval
7.. broad release of the vaccine
7.. collect post approval safety and efficacy data
This is all a very, very, very very advanced timeline. One little hiccup in any step could doom the vaccine and your basically starting from zero.
A few more are close but j and j has the resources. Merk and Sanofi Aventis would be my other bets as they have very good vaccine and manufacturing abilities with very large scientific knowledge banks.
Vaccines are tough to develop. Coronavirus vaccines are difficult, and fingers crossed one is effective soon.
I've worked in bio med mfg., and am professionally familiar with that process. It was harder in my day, computer modelling has come a very long way since then.
The fed can waive some of that, and expedite some more of it. Some of it can be worked in parallel. As you mentioned, you can do volume production in advance of approval, and I believe Fauci said the Fed will help underwrite the financial risk.
Some of the timeline is economic in nature (ie don't commit money to step B until you know step A is good) and some is bureaucratic. But this is a national emergency, leadership can accept some risk to expedite a solution. That risk will be balanced with the risks of allowing ongoing economic disaster, and decisions made at the appropriate times.