Oso planning to go pro
Moderna Therapeutics said Wednesday that the drug-making company’s coronavirus vaccine won’t be available for widespread distribution until at least next springCEO Stéphane Bancel told the Financial Times that Moderna would not apply for emergency use authorization from the Food and Drug Administration until at least Nov. 25. An emergency use authorization lets frontline medical workers and at-risk individuals use the vaccine during the pandemic.Bancel also told the publication that his company will not seek FDA approval for vaccine use in the general population until late January, adding that such an approval will more likely come closer to late March or early April.
Ballsy move by the FDA, and the right move if they want the public to have any confidence in the safety of any Covid vaccine that gets approved.
57-41
Great news from Eli Lilly this morning. A reduction in ER/hospital visits from almost 6% in placebo to under 1% with this antibody cocktail.Ready to roll out millions of doses, let’s get it done!!https://www.google.com/amp/s/www.wsj.com/amp/articles/eli-lilly-asks-fda-to-authorize-covid-19-antibody-drug-11602074998
Again, from very early on I've been a proponent of these monoclonal antibodies being the most likely to have an impact on COVID in a rapid manner. It was a major strategic error by the administration not to include these in project Warp speed. There should have been billions of dollars guaranteed to these companies to backstop the cost in production (in case trials failed), and they should have been being pushed hard in accelerated trials. And financial support to ensure that every American could have access and afford these expensive drugs.
Polling #s.
Have they ever been asked why these monoclonal antibodies weren’t included? Would be interesting to see if the medical folks consulting Operation Warp Speed fought for the inclusion and told no for some reason or if it was really never discussed by Fauci, Birx, etc.. as an option.
The Whitehouse has been notified, the group of scientists in the COVID-19 advisory group (partnering with manufacturers and billionaires), clearly indicated the importance of monoclonal antibodies as the most likely bridge to a vaccine. That groups insistence on its importance is what let the administration to work with Regeneron (possibly saving the president's life). It was highly prioritized. Now, for the mea culpa. I know people on that advisory group. My criticism is in part unwarranted and incomplete. Operation Warp Speed did fund Regeneron's production, I had missed this. But only enough funding to backstop 70k-300k doses, far too low to be widely available to the public this calendar year. That is still a major strategic error.Other promising candidates either did not obtain any funding, or simply received funding to help support trials (not production), with the priorities going to vaccines instead. The big cost and risks are in production, which is why in most drug developments, planning and scaling up production waits to after phase 3, when you have a good baseline for whether it will be approved or not.The WH decided to prioritize vaccines and try to rush them out by Election Day. That was their strategic decision.
Interesting, thanks for detailed update. In hind sight you’re saying those priorities should have been flipped with the antibody development taking precedent over the vaccine or both routes treated more equally in importance?Glad to hear the task force helped with some of the support for trails/production in what appears to be a pretty promising treatment cocktail and it wasn’t negligence/denial that jockey throws around with no evidence. Your criticism is that they’re should have been more support/funding if I’m reading you correctly? With more support these treatments you think might have been readily available by now?
I won't speak for forgetful, but my sense is that monoclonal antibody therapy should have been better funded generally - both at Regeneron and other companies.The emphasis (overemphasis?) on getting a vaccine out before the election arguably took funds away from these monoclonal antibody studies, and the resources to produce and distribute them.