CDC Notifies States, Large Cities To Prepare For Vaccine Distribution As Soon As Late October

[Jonfw2]

I want a helicopter to land on my front lawn and take me to the hospital if I get COVID. I then want all of the experimental stuff too.

I can't promise the helicopter, but the experimental stuff is coming very, very soon.

 

[JaxDad]

"the White House chief of staff objected to provisions that would push approval past Election Day. "

What a shock. I'm flabbergasted. Truly gobsmacked.

Does anyone know why the FDA was proposing new, stricter guidelines for COVID?

 

[okeydokey]

Does anyone know why was the FDA proposing new, stricter guidelines for COVID?

They are not. The White house is trying to force less strict guidelines than the companies want to agree with. I was on a webinar with a person from one of them recently and he said that the major companies (I think he said 7?) entered into an agreement to hold tight to the science so that people will know that the vaccines are being created the safe way.

People need to have confidence that this process is safe and effective or they won't take the vaccine. Political needs have to step aside.

 

[FlightlessDuck]

Does anyone know why the FDA was proposing new, stricter guidelines for COVID?

We don't even know what the guidelines are, because they were blocked from being released.

The only information that can be gleaned from the article is this:

F.D.A. officials later provided additional justification to the White House, explaining that the two-month follow-up was necessary to identify possible side effects and ensure that a vaccine’s protection against Covid-19, the disease caused by the coronavirus, was not short-lived.

 

[JaxDad]

They are not. The White house is trying to force less strict guidelines than the companies want to agree with. I was on a webinar with a person from one of them recently and he said that the major companies (I think he said 7?) entered into an agreement to hold tight to the science so that people will know that the vaccines are being created the safe way.

People need to have confidence that this process is safe and effective or they won't take the vaccine. Political needs have to step aside.

Just going by the article subtitle...
"The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day."

 

[okeydokey]

The subtitle doesn't tell the story, nor does one article.

 

[Jonfw2]

I wonder if Eli Lilly's treatment also uses embryonic stem cells like in Regeneron. Some folks may prefer the non-embryonic cell treatment for this reason. It will be interesting to see how this plays out.

So, I can clarify this: Regeneron's antibody drug does NOT use embryonic stem cells. The confusion came from a report that said the drug itself was called "Regeneron". It's not. That's the name of the company.

 

[mousefan73]

Does anyone know why the FDA was proposing new, stricter guidelines for COVID?

Well according to Dr. Gottlieb, Board of Pfizer, these are NOT new stricter guidelines, but have been communicated for the past few months.. This timeline and process is nothing new, these are not "newer, stricter" . He also stated that officials in the WH had no issue with this. Mr. Trump had a Twitter moment concerning the election. He was on MSNBC this morning and addressed this.

edit: He also mentioned the anitbodies and most likely this will be the focus the next few weeks, politically speaking, less vaccine, more antibody.. A quicker win if Nov 3 is the timeline.

I suggest you guys find his interview online from today. He is on almost daily and IMO gives great insight. you can find usually his segments on Twitter. He's on Squawkbox

 

[Jonfw2]

Trump reiterated today that the immediate focus is treatment over vaccine.

 

[aggiedog]

Because that gets him possible good press prior to the election - though any treatment will need to be used on many patients to determine real efficacy and safety - but these treatments are much closer to that than any of the vaccines.

 

[Jonfw2]

Because that gets him possible good press prior to the election - though any treatment will need to be used on many patients to determine real efficacy and safety - but these treatments are much closer to that than any of the vaccines.

Trump's not the first person to get these- they've both been tested on hundreds of people with Covid and they've shown a noticeable positive impact.

 

[sam_gordon]

Trump's not the first person to get these- they've both been tested on hundreds of people with Covid and they've shown a noticeable positive impact.

From USA Today (link) (bolding mine)

This drug and similar monoclonal antibodies, including one made by Eli Lilly and Co., of Indianapolis, remain under development and are not yet approved for use in the U.S. or elsewhere. Trump was able to get it under a "compassionate use" exemption, which the company said it has granted to fewer than 10 people so far, after requests from their doctors and approval by the U.S. Food and Drug Administration, a process that typically takes days to weeks.

REGN-COV2 (the drug from above) has been given to about 2,000 people as part of clinical trials.

 

[Jonfw2]

From USA Today (link) (bolding mine)


REGN-COV2 (the drug from above) has been given to about 2,000 people as part of clinical trials.

Okay. I said hundreds. It's 2,000 then. Fair enough.

 

[godisney14]

You can be contagious even with a negative rapid test.

https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6940e2-H.pdf

CDC just put out a report on an incident of spread where the index case was a 13 year old adolescent.

This is a very interesting case study for a few reasons:

• contact tracing conducted back to index case
• case study of a situation where a rapid test result was unreliable (as I have mentioned previously, rapid tests have a relatively narrow range of reliability)
• further proof that a child can easily spread infection just as an adult

Whether it’s with family or friends, limit gatherings and wear masks. Stay home when you’ve been possibly exposed, and especially when you show any kind of symptoms possible with COVID-19.

 

[Colleen27]

I want a helicopter to land on my front lawn and take me to the hospital if I get COVID. I then want all of the experimental stuff too.

And don't forget... someone else to pay the six-figure cost of those treatments!

 

[mom2rtk]

I want a helicopter to land on my front lawn and take me to the hospital if I get COVID. I then want all of the experimental stuff too.

Then you should probably run for office.

 

[Jonfw2]

And don't forget... someone else to pay the six-figure cost of those treatments!

the government has already pledged to provide these treatments and the vaccines for free.

 

[Colleen27]

the government has already pledged to provide these treatments and the vaccines for free.

I've read that about the vaccine but not about any of the treatments currently in development. But even if the treatment itself is free, the days in hospital and team of doctors and other aspects of top-notch medical care won't be.

 

[Jonfw2]

I've read that about the vaccine but not about any of the treatments currently in development. But even if the treatment itself is free, the days in hospital and team of doctors and other aspects of top-notch medical care won't be.

Doesn’t require top notch medical care. Just requires access and an injection.

 

[godisney14]

Doesn’t require top notch medical care. Just requires access and an injection.

Haha, only if it was as easy as being administered a vaccine. That is definitely not how an individual gets treated with these options for COVID-19.