Vaccine/Antibody updates

[Jockey]

Moderna Therapeutics said Wednesday that the drug-making company's coronavirus vaccine won't be available for widespread distribution until at least next spring

CEO 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.

[wadesworld]

The president said in the next couple weeks.

Who are you gonna believe?

[GooooMarquette]

Moderna Therapeutics said Wednesday that the drug-making company's coronavirus vaccine won't be available for widespread distribution until at least next spring

CEO 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.

And when the company says not until at least 'next spring,' they are giving you their educated guess on the best-case scenario. Typical CEO trying to encourage shareholders without violating SEC rules. And it isn't surprising, or necessarily the company's fault - you can only speed things along so much in vaccine development, no matter how many resources you plough into it. Ethical review boards, data safety monitoring boards, unpredictable side effects - they all add time to a necessarily time-intensive process.

I will be pleasantly surprised if we have a vaccine in widespread distribution by mid-2021. Earlier might have been great, but it's a pipe dream IMO.

[shoothoops]

https://twitter.com/markmobility/status/1313263900062777344?s=19

"White House blocks new FDA COVID-19 Vaccine guidelines"

[GooooMarquette]

The F.D.A. releases advice for vaccine developers, including recommendations the White House had blocked.

https://www.nytimes.com/live/2020/10/06/world/covid-coronavirus?name=styln-coronavirus-markets&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=Article&impression_id=cb63f870-0804-11eb-8e53-77965d24cd50&variant=1_Show#the-fda-releases-advice-for-vaccine-developers-including-recommendations-the-white-house-had-blocked

The Food and Drug Administration on Tuesday released a summary of the advice it has given to developers of vaccines for Covid-19. The advice contained key parts of new F.D.A. vaccine guidelines that the White House had blocked.

The advice was nestled at the end of a document the F.D.A. prepared for the meeting on Oct. 22 of the Vaccines and Related Biological Products Advisory Committee. The committee will be discussing the development, authorization and licensing of Covid vaccines.

-----------

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.

[Frenns Liquor Depot]

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.

We need this.  Interestingly Pfizer CEO also tweeted on this topic today as well as Scott Gottlieb on interviews (BOD member for Pfizer but former Head of FDA) try to support the integrity and independence of the FDA.

It seems like the CDC is also waking up that they need to do their jobs with yesterdays reinstitution of the aerosol guidance. 

There seems to be something that emboldened the scientists recently.  Not sure if its the Atlas dynamic or the admin just cutting the agencies out, but something happened to get them to speak up.

[tower912]

57-41

[rocky_warrior]

57-41

=16

The google search box will do math for you if you type in the equation 

[tower912]

Random numbers

[copious1218]

57-41

Halftime of Game 4 tonight?

[tower912]

Perhaps.

[MU Fan in Connecticut]

57-41

Polling #s.

[Warriors4ever]

 Yeah, I knew. But it's only the swing states that matter.

[pacearrow02]

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

[forgetful]

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.

[Jockey]

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.

I would use negligence or denial rather than "strategic error", but you are 100% correct.

[pacearrow02]

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.

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.

[HansMoleman]

Polling #s.

Oct 2016 polling #s

[Frenns Liquor Depot]

It would be interesting to hear why it wasn't included. 

I dont know why the conjecture about doctors opposing, you could as easily make a case that the head of the pandemic response was against them because they use stem cells in their development.  But instead of unhelpful conjecture maybe there is a source that is out there.

Here are some:
https://www.politico.com/news/2020/10/02/warp-speed-covid-antibody-treatments-425649

https://www.statnews.com/2020/09/08/operation-warp-speed-promised-to-do-the-impossible-how-far-has-it-come/

https://www.sciencemag.org/news/2020/08/designer-antibodies-could-battle-covid-19-vaccines-arrive

Conclusion: It's been long ID'd that we are not ramping up capacity here as part of Warp speed, just trial support.  No discussion I could find about why or who.

[forgetful]

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.

[pacearrow02]

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?

[GooooMarquette]

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.

[Hards Alumni]

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.

Eh, hindsight is 20/20.  No win situation.  If these therapies were unsuccessful, then the government would have caught criticism for wasting money, or a corporate giveaway.  I'm fine with funding all of these therapies, but it's easy to say which one we should have thrown more money at after the fact.

[tower912]

Both/and, not either/or.   

[forgetful]

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?

Gooo pretty much has it right. By no means should the priorities have been flipped. But the monoclonal antibody therapies should have been better funded, both at Regeneron and other options. For an extra $1-2B, we could have these treatments in widespread usage right now around the nation.

In my opinion, the WH lost sight of the forest for the trees. They looked at this as an election issue. Getting a vaccine by Election Day became priority number 1, 2, and 3. They lost focus on the overall picture and long term plan/goals.

Also my opinion, and not at all related to any information I have from others, but I believe that member of the Trump administration did not, and still do not, fully understand the difference between antibody treatments from convalescence plasma, and these monoclonal cocktails. I think this led some in the administration to simply decide, the convalescent plasma would be a sufficient bridge to a vaccine.

I also think their absurd belief that HCQ was truly a miracle cure, disrupted funding to more promising options.