Trump’s vaccine czar says the first vaccine should be submitted for emergency authorization around T

[PeteS in CA]

Trump’s vaccine czar says the first vaccine should be submitted for emergency authorization around Thanksgiving

https://www.marketwatch.com/story/trumps-vaccine-czar-says-the-first-vaccine-should-be-submitted-for-emergency-authorization-around-thanksgiving-2020-10-08?mod=home-page

Moncef Slaoui, an immunologist by training and a longtime pharmaceutical executive, is running the Trump administration’s Operation Warp Speed program to spur development of vaccines on the fastest ever timetable.

While none of the four vaccine candidates to enter Phase 3 trials have publicly reported data from the mid-stage studies, Slaoui is hopeful that drug makers will file for emergency authorization with the Food and Drug Administration by late November, immunization in high-risk populations could begin this year, and that the vaccines may be more effective in clinical trials than previously assumed.

“My expectation is really something between 80% and 90% efficacy,” he said.
...
“I hope this never happens again, that such events are politicized,” he told MarketWatch on Wednesday. “We’re forgetting something, which is people are dying, and forgetting another thing, which is never ever before has an effort of this proportion been made and vaccines been developed in a period of less than a year.”

Actually there are five vaccines in Phase III in the Operation Warp Speed effort - AstraZeneca, Moderna, Pfizer, Johnson & Johnson, and Novavax. The one that's been in Phase II - outside of the US - is AstraZeneca. Moderna and Pfizer started Phase III the same day, but Moderna started Phase I earliest, so it may have more data from earlier phases.

One hidden implication in the backing-and-forthing about early or late November authorization is that the necessaries and logistics for distribution to start in early November will be ready for either timing.

My guess, from the timing of testing starts is that AstraZeneca will receive authorization in November - probably the latter half - Moderna will receive authorization in December, and Pfizer will receive authorization in late December or January. All have production facilities and distribution outlets in place, and the US military may assist with some of the logistics. Then J & J and/or Novavax will probably receive authorization some time in the spring. There are a couple more that are even earlier in the process, including one that would be oral rather than by injection.

The big picture is that the vaccine "eggs" are in multiple "baskets", with authorizations coming in stages that will continually increase supply. Also, it's not "just" the US government that has purchase contracts with all these various companies. OWS will end up benefiting much of the world.

[jmyrlefuller]

Let's hope they work.

[PeteS in CA]

Let's hope they work.

Phase III for each vaccines involves 30,000-60,000 patients each. And if AstraZeneca is doing separate Phase III tests in the several countries, probably 10s of thousands more. So the vaccines are being tested with at least 150K-300K people, and probably 10s or even 100s of thousands more.

The Dems and their MSM-shills are trying FUD tactics, maligning these vaccines as largely untested, when they are in fact being fully tested under protocols that mostly eliminate bureaucratic delays.

FUD = Fear, Uncertainty, and Doubt