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

[anniemae]

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.

Are you in the Pfizer trials? when will you know if you got the vaccine or placebo?

 

[Jonfw2]

Are you in the Pfizer trials? when will you know if you got the vaccine or placebo?

We are in Moderna. Are hope is that the study will be unblinded after they get emergency approval.

 

[mefordis]

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.

This sounds like the case in children. It seems that children wouldn't need the vaccine since they have robust immune systems already and we are seeing so very few of them sick from this virus. It seems that those who could use the vaccine are the ones whose immune system is weak or those with co morbidities who have a higher risk of dying.

 

[DLgal]

This sounds like the case in children. It seems that children wouldn't need the vaccine since they have robust immune systems already and we are seeing so very few of them sick from this virus. It seems that those who could use the vaccine are the ones whose immune system is weak or those with co morbidities who have a higher risk of dying.

Yes, exactly right. However, children also have far less ACE2 receptors expressed on their cells, which also offers protection from this virus. As we age, and as a result of certain health conditions, the number of ACE2 receptors increases. It seems that children's frequent exposures to other coronaviruses and more recent vaccinations also provide a higher level of protection from this virus, due to higher circulating antibodies. It is already known that many viral vaccines produce something called crossover immunity (where a vaccine designed to protect against one virus ends up protecting against others). So, vaccinated kids in general have more responsive immune systems than older teens and adults due to shorter time from last vaccines. It has been theorized that anyone who has recently been sick with a cold, or even people who have recently received a "live" vaccine like the Flu Mist will also have a higher level of protection from Covid due to crossover immunity.

 

[bethbuchall]

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."

I know in the study I'm in, we were tested for COVID-19 only twice--once before each shot. We filled out a diary weekly as to any COVID-19 symptoms that we were experiencing and were to get tested if we displayed symptoms (or any time we decided that we may need a test). I do think that they should have tested more often to pick up any asymptomatic cases, but I'm not a scientist. They also drew blood for antibody testing pre-vaccine and again after both doses. So, they can state at this point that it prevented symptomatic and severe cases much better than the placebo during this trial and what resulting antibody production there was.

 

[Jonfw2]

Well, I have some news:

The owner of our local urgent care and I have been chatting about Covid stuff since this started. She has been very curious about the study, as she believes her facility will likely get some of the Moderna vax.

Tonight, she personally gave us antibody tests. I was negative, but my wife was positive.

As we suspected, I got the placebo and she got the real vaccine.

 

[DLgal]

Well, I have some news:

The owner of our local urgent care and I have been chatting about Covid stuff since this started. She has been very curious about the study, as she believes her facility will likely get some of the Moderna vax.

Tonight, she personally gave us antibody tests. I was negative, but my wife was positive.

As we suspected, I got the placebo and she got the real vaccine.

Cool to know, but didn't you have to sign something that said you wouldn't do something like that? You just compromised the study by unblinding yourself. Now you might change your behavior.

 

[Jonfw2]

Cool to know, but didn't you have to sign something that said you wouldn't do something like that? You just compromised the study by unblinding yourself. Now you might change your behavior.

the study that reported its results today?

 

[DLgal]

the study that reported its results today?

It's still ongoing. Those are preliminary results.

 

[lifesavacation]

Cool to know, but didn't you have to sign something that said you wouldn't do something like that? You just compromised the study by unblinding yourself. Now you might change your behavior.

I know 2 people who were trial participants who got private antibodies tests.

 

[DLgal]

I know 2 people who were trial participants who got private antibodies tests.

Interesting. I am not participating in any trial, but I thought I read somewhere that behavior that "unblinds" a double blind study means that person has to withdraw from the study. Whether it is intentional or not. I would have assumed this would fall under intentional unblinding.

 

[bethbuchall]

Cool to know, but didn't you have to sign something that said you wouldn't do something like that? You just compromised the study by unblinding yourself. Now you might change your behavior.

That was not something that I agreed to in my study. I've chosen not to unblind myself, but they never said that I was not to take an antibody test.

 

[DLgal]

That was not something that I agreed to in my study. I've chosen not to unblind myself, but they never said that I was not to take an antibody test.

Thanks for clarifying. I also did read that part of the initial FDA request for EUA is to allow the companies to unblind the trials so they can administer the vaccine to the placebo group on the grounds that it would be unethical not to, given the vaccine's success rate.

 

[Jonfw2]

So did I compromise the study or not?

 

[Mackenzie Click-Mickelson]

So did I compromise the study or not?

Psychologically speaking unblinding yourself can jeopardize the study because it can, consciously and subconsciously, altar your behavior. This vaccine study does rely on behavior. It's also why studies set up as double blind become paramount to keep it that way because the ones conducting the study can find themselves altering their behaviors which place the results in doubt. I am not sure how these studies were set up.

That said you'd have to look at your documents you signed for whether it was against the trial rules or not (fine print and all). I do know they are concerned with volunteers leaving the study if they find out they had the placebo because they want the vaccine, there's also cross-participants who were in multiple trials with different companies. Morally and ethically they would want the trial participants who got the placebo to get the vaccine; the timing of it is the crux because of needing to study longer term effects with both a placebo and with a vaccine.

 

[Jonfw2]

Psychologically speaking unblinding yourself can jeopardize the study because it can, consciously and subconsciously, altar your behavior. This vaccine study does rely on behavior. It's also why studies set up as double blind become paramount to keep it that way because the ones conducting the study can find themselves altering their behaviors which place the results in doubt. I am not sure how these studies were set up.

That said you'd have to look at your documents you signed for whether it was against the trial rules or not (fine print and all). I do know they are concerned with volunteers leaving the study if they find out they had the placebo because they want the vaccine, there's also cross-participants who were in multiple trials with different companies. Morally and ethically they would want the trial participants who got the placebo to get the vaccine; the timing of it is the crux because of needing to study longer term effects with both a placebo and with a vaccine.

Yeah...I think I'm good.

 

[Mackenzie Click-Mickelson]

Yeah...I think I'm good.

You might be good but that's really up to whatever trial you're under. IDK I would just check. I'm coming from a psychology background where I have conducted a study myself under a grad student and coded the results and been a participant in studies (for college) myself. Honestly, I've appreciated your wealth of information and agree often with what you say but this is one thing I would not have shared on the DIS. That is purely my opinion and absolutely no disrespect meant. With that I'll leave it alone

 

[Mackenzie Click-Mickelson]

Local news covered that the state next to mine could receive Pfizer's vaccine around December 15th if it was approved through EUA. It would be 1 shipment with 50,000 doses.

 

[bethbuchall]

Thanks for clarifying. I also did read that part of the initial FDA request for EUA is to allow the companies to unblind the trials so they can administer the vaccine to the placebo group on the grounds that it would be unethical not to, given the vaccine's success rate.

We were told (and it's in the paperwork that we signed) that once the vaccine is approved for use, we'd be told if we received the vaccine or placebo and allowed to get the vaccine, if we want to. They told us that it would be unethical not to let us know and allow us to get a vaccine that is out. We weren't told that we would be given the vaccine or have early access to it, but I've read in other sources (that may be inaccurate) that Pfizer may take the placebo arm into the vaccine arm to keep participants in the study.

 

[aggiedog]

It absolutely makes sense that the placebo patients would be offered the vaccine at the end, or when the study managers feel it is appropriate. I've seen several studies designed that way, particularly regarding therapeutics. I also agree that knowing if you are placebo or not prior to the study's stated end point, when THEY want you to know, may be problematic. Double blind trials are designed that way for a reason. Whether that's an issue in the above case is based on information I don't have.