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

[DLgal]

Can anyone tell me why the meeting for the EUA is not until Dec 10? It is my understanding that the paperwork was filed a week ago- what is taking them so long? I understand they need to review the information but considering the dire need you would think that they could skip black friday shopping and put in some over time? (sorry don't mean to be cross about this but I truly don't understand why it is taking two weeks to meet!)

Governments don't do anything quickly and efficiently. You should know this by now. This IS the fastest they can get this done.

 

[Jonfw2]

As everyone here knows, nobody on earth wants these vaccines approved and done so quickly more than I do- having said that, I'm completely on board with the FDA's timeframe. There is A TON of material to digest here and it is absolutely critical they do this right.

 

[BrianL]

As everyone here knows, nobody on earth wants these vaccines approved and done so quickly more than I do- having said that, I'm completely on board with the FDA's timeframe. There is A TON of material to digest here and it is absolutely critical they do this right.

Right. As long as they are making steady progress I'm good. We've just got to hang in there.

 

[Katiebird]

Can anyone tell me why the meeting for the EUA is not until Dec 10? It is my understanding that the paperwork was filed a week ago- what is taking them so long? I understand they need to review the information but considering the dire need you would think that they could skip black friday shopping and put in some over time? (sorry don't mean to be cross about this but I truly don't understand why it is taking two weeks to meet!)

Apparently the FDA is required to publish notices for these meetings, before the first of the month it happens in, and at least 15 days before it happens. They announced the meeting ~20 days ahead of time, and published it (iirc) ~17 days ahead.

FDA applications are also thousands of pages long, and while I’m sure they already know they’ll approve, they still need to actually review the applications.

 

[anniemae]

They said on the news that the Moderna vaccine is the one that does not require special storage. The Pfizer one does. I thought they said the Pfizer one would be the one that he masses would most likely get. Wouldn't the easier to transport/store vaccine i.e. the moderna one be the one most would get?

 

[Jonfw2]

They said on the news that the Moderna vaccine is the one that does not require special storage. The Pfizer one does. I thought they said the Pfizer one would be the one that he masses would most likely get. Wouldn't the easier to transport/store vaccine i.e. the moderna one be the one most would get?

That's correct on the storage. It is trickier for Pfizer. But the concerns have been pretty overblown- Pfizer has never once given any indication that they would have a problem with transporting and storing.

The simple reason the Moderna one won't be the first "go to" is that the Pfizer one will likely be approved a few weeks earlier.

 

[mefordis]

Reading this article it seems like the goal of the vaccines are to prevent "severe disease", not actually prevent the virus. At least that's how I'm reading the results of the trials. I don't see any mention of those taking the vaccine testing positive or negative, just whether or not they had severe symptoms. Please let me know if I have overlooked this in the article.

https://www.sciencemag.org/news/202...ernas-vaccine-trial-developed-severe-covid-19
"Only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says, far above what many vaccine scientists were expecting just a few weeks ago."

 

[Jonfw2]

Reading this article it seems like the goal of the vaccines are to prevent "severe disease", not actually prevent the virus. At least that's how I'm reading the results of the trials. I don't see any mention of those taking the vaccine testing positive or negative, just whether or not they had severe symptoms. Please let me know if I have overlooked this in the article.

https://www.sciencemag.org/news/202...ernas-vaccine-trial-developed-severe-covid-19
"Only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says, far above what many vaccine scientists were expecting just a few weeks ago."

Well...no.

The goal of the vaccines is to prevent you from getting it in the first place. Which they did at a rate far better than expected.

It's essentially a bonus that of the very few who actually got Covid, none got severe symptoms.

 

[Jonfw2]

"“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy".

https://www.cnbc.com/2020/11/30/mod...e-plans-to-apply-for-emergency-ok-monday.html

 

[mefordis]

Well...no.

The goal of the vaccines is to prevent you from getting it in the first place. Which they did at a rate far better than expected.

It's essentially a bonus that of the very few who actually got Covid, none got severe symptoms.

I'd like to know how many tested positive with Covid after receiving the second vaccine. All this article tells me is that 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. How many more who received the vaccine tested positive but with no symptoms?

Asymptomatic people can still spread the virus. Hence, the need for long term mask mandates.

 

[Jonfw2]

I'd like to know how many tested positive with Covid after receiving the second vaccine. All this article tells me is that 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. How many more who received the vaccine tested positive but with no symptoms?

Asymptomatic people can still spread the virus. Hence, the need for long term mask mandates.

Well, Moderna's CEO used the word PREVENT. Not sure what else I can tell you.

 

[mefordis]

Okay on the CHOP website, my question is answered:

• The vaccine will likely be highly effective at preventing disease but might not be as effective at preventing asymptomatic infection, where the recipient of the vaccine might not get sick but could still spread the virus.

https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/prevent-covid

 

[mefordis]

Well, Moderna's CEO used the word PREVENT. Not sure what else I can tell you.

Looking for the numbers of those in trials who tested positive for Covid19 after receiving the vaccine. I assumed the vaccine would prevent testing positive for Covid19, not just lessen the symptoms.

 

[Jonfw2]

Okay on the CHOP website, my question is answered:

• The vaccine will likely be highly effective at preventing disease but might not be as effective at preventing asymptomatic infection, where the recipient of the vaccine might not get sick but could still spread the virus.

https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/prevent-covid

That page has not been updated to reflect the actual vaccine results now coming in.

 

[Jonfw2]

Looking for the numbers of those in trials who tested positive for Covid19 after receiving the vaccine. I assumed the vaccine would prevent testing positive for Covid19, not just lessen the symptoms.

I can tell you from personal experience, we received Covid tests 3 times during our trial. We also had blood work for antibody detection 3 times. Had we tested positive while asymptomatic, that would have been picked up, as would any antibody development.

 

[mefordis]

I can tell you from personal experience, we received Covid tests 3 times during our trial. We also had blood work for antibody detection 3 times. Had we tested positive while asymptomatic, that would have been picked up, as would any antibody development.

Just looking for recent data from the trials showing how many tested positive after receiving the vaccine, first then second dose. I'll continue to look.

 

[NotUrsula]

Arrived at O'Hare overnight!

15,000 pounds of dry ice wow! I did remember reading recently that United would be part of it kinda cool when you think about it, everyday airline company being part of it.

What that story doesn't make clear is that getting permission for 15,000 lbs of dry ice isn't the sticking point; it's getting permission for sealed containers of dry ice on a plane at all. The FAA normally restricts dry ice to no more than 5.5 lbs per package (440 lbs of it total for the flight), and they require that special vented containers be used. There are 2 hazards to having it on a plane: 1) as it melts it forms gas, so in a sealed container it is a pressure explosion hazard, and 2) the gas is CO2, so the formation of the gas displaces the oxygen in the pressurized cabin.

Most air cargo carriers simply will not transport dry ice (FedEx will not, in any quantity), it's just too great a potential liability that could wipe out the entire cargo (and the crew, of course) if there was a problem with the container.

In other interesting news, the interim results of the Stage 3 Oxford trial came in a few days ago; they show 60% effectiveness, which is considered very promising, because it uses a simpler vaccine design and has the least restrictive storage requirements. This one only needs to be cooled to about 40F, so it is fine in an ordinary cooler or fridge; super important in parts of the world where electricity is a scarce commodity. It also costs less than $5/dose. Assuming nothing happens in the final testing phases to knock it off course, this one is probably going to end up being the most widely used worldwide. (Nature has an article this week about one very surprising result that is showing up in their data: a site that reversed the usual quantities and administered the smaller "booster dose" before the full-strength main dose actually showed better immune response, so they want to test that more widely. If it holds true, it will help the vaccine distribution situation immensely because the earlier doses will go twice as far, buying a lot of time to make the larger quantities for the second dose.)

 

[jlwhitney]

I'd like to know how many tested positive with Covid after receiving the second vaccine. All this article tells me is that 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. How many more who received the vaccine tested positive but with no symptoms?

Asymptomatic people can still spread the virus. Hence, the need for long term mask mandates.

There will become a point its going to fall back to personal responsibility like most things in life. If you get the vaccine for the most part the point won't matter. If you are uber high risk for it and can't or don't get the vaccine that its on that person to do what they need to limit their risk just like they do with every other contagious illness. The general public isn't going to take long term masking and such for years or even another full year, especially once they can get the vaccine or at least feel like they have the option to.

 

[Mackenzie Click-Mickelson]

What that story doesn't make clear is that getting permission for 15,000 lbs of dry ice isn't the sticking point; it's getting permission for sealed containers of dry ice on a plane at all. The FAA normally restricts dry ice to no more than 5.5 lbs per package (440 lbs of it total for the flight), and they require that special vented containers be used. There are 2 hazards to having it on a plane: 1) as it melts it forms gas, so in a sealed container it is a pressure explosion hazard, and 2) the gas is CO2, so the formation of the gas displaces the oxygen in the pressurized cabin.

Most air cargo carriers simply will not transport dry ice (FedEx will not, in any quantity), it's just too great a potential liability that could wipe out the entire cargo (and the crew, of course) if there was a problem with the container.

In other interesting news, the interim results of the Stage 3 Oxford trial came in a few days ago; they show 60% effectiveness, which is considered very promising, because it uses a simpler vaccine design and has the least restrictive storage requirements. This one only needs to be cooled to about 40F, so it is fine in an ordinary cooler or fridge; super important in parts of the world where electricity is a scarce commodity. It also costs less than $5/dose. Assuming nothing happens in the final testing phases to knock it off course, this one is probably going to end up being the most widely used worldwide. (Nature has an article this week about one very surprising result that is showing up in their data: a site that reversed the usual quantities and administered the smaller "booster dose" before the full-strength main dose actually showed better immune response, so they want to test that more widely. If it holds true, it will help the vaccine distribution situation immensely because the earlier doses will go twice as far, buying a lot of time to make the larger quantities for the second dose.)

I honestly was just more thinking about how much dry ice that is (because who here has thought about 15,000 pounds of it!?) not necessarily considering the background permissions and whatnot (as the article mentioned normally there are limitations) but thanks for the additional information and about the Oxford vaccine

 

[DLgal]

Reading this article it seems like the goal of the vaccines are to prevent "severe disease", not actually prevent the virus. At least that's how I'm reading the results of the trials. I don't see any mention of those taking the vaccine testing positive or negative, just whether or not they had severe symptoms. Please let me know if I have overlooked this in the article.

https://www.sciencemag.org/news/202...ernas-vaccine-trial-developed-severe-covid-19
"Only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says, far above what many vaccine scientists were expecting just a few weeks ago."

Ok, here is the quick and dirty: VIRAL vaccines (as opposed to bacterial vaccines) are designed to prevent SEVERE ILLNESS AND DEATH, and they do NOT always prevent viral entry and subsequent viral replication in your cells. For example, the flu shot does not prevent you from contracting flu and getting sick, but it is mostly effective at preventing severe illness, hospitalizations, and deaths.

The long, complex explanation:
Viruses are not "alive." They are microscopic particles consisting of DNA surrounded by a shell of sorts. They are similar to parasites. They cannot "live" without a host. So, when you are infected by a virus, that means the virus organism has entered YOUR cells, hijacked them and turned your cells into little replication factories that churn out more and more virus infected cells. When your cells are so full of virus DNA, they explode and release new virus particles, which then hijacks new healthy cells to start the process again. This cellular death is what triggers your immune system to respond. It goes "what caused all those cells to die?" Once your immune response messenger cells determine what is killing all the healthy cells, it identifies the pathogen and starts attacking it using antibodies and other killer cell types. At this point, you are heavily infected, and your symptoms are the result of this cellular warfare and the side effects of all the destruction.

When you get a vaccine, it sort of simulates this process, but with weakened or inactivated virus, as like a practice run. Your immune response learns how to fight the virus and then remembers how for next time. It is ready. This is why sometimes vaccines make you feel a bit under the weather.

Now imagine you are exposed to the virus later. Your immune response begins when the first cell that has been infected dies off. The response is fast and furious, and your immune system quickly takes care of the virus, well before it has replicated out of control. You don't get sick, because the amount of cell death was minimized and contained. However, you DID still get infected, technically.

Now, these vaccines are designed to detect the protein spikes that cover the surface the SARS-COV2 virus. The hope is that by targeting this spike, they can train your immune system to detect the presence of this spike as an enemy. The virus uses this spike to attach to the ACE2 receptors on the surface of cells in our noses, throats, and lungs. The spike is kind of like a key and the ACE2 receptor is like a lock. The key has to fit in the lock, which is what allows the virus to inject its DNA into our cells. Ideally, this vaccine teaches our cells that this "key" is an enemy, so our cells should NOT allow it to attach to the "lock." In essence, we are trying to get our cells to block the key, so that the virus CANNOT enter our cells, and instead simply gets eaten by our innate immune cells. The goal is to prevent viral replication in theory, but in practice, it obviously did not work 100%.

In the case of this particular vaccine, 6% of vaccine recipients contracted the virus and then showed symptoms, which is the definition of "Covid-19." Covid-19 is the disease caused by SARS-COV2.

Someone who is asymptomatic, but tests positive for the presence of the virus does not "have Covid-19." Essentially, this means the person has an excellent immune system that quickly neutralized the virus before it spread to lung cells, or in the case of the vaccine trial, the vaccine worked. It is unknown how many vaccine recipients tested positive for the virus while remaining asymptomatic. If that data was collected during the trials, it may be part of the data set that will be reviewed, although at this time, only one vaccine company has publicly stated that they DID collect this data during the trial and it DID indicate the vaccine prevented INFECTIVITY (which means that no virus particles capable of replication were detected during routine nasal swabs). That is good news.