Coronavirus

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TheStorm
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bigeric said:

I have felt for some time that it is somewhat unseemly for Big Pharma to be advertising their expensive new drugs to the general populace. Especially with the admonishment to "let your doctor know" of all the drugs are taking, as if your doctor isn't the prescribing physician. Otherwise they could be encouraging doctor shopping in order to get the latest and greatest drug.
Honestly to me anyway, the "advertising" is just their "tax payment" to the propaganda peddlers (mainstream news outlets and big tech) for them to carry their share of the water for them...

These companies are making a fortune on these vaccines and so are all the government officials (on both sides) that all have their hands in the pot... and then you have the mainstream news outlets pushing the vaccine mandate narratives... it is ALL interconnected.
FlossyDFlynt
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bigeric said:

I have felt for some time that it is somewhat unseemly for Big Pharma to be advertising their expensive new drugs to the general populace. Especially with the admonishment to "let your doctor know" of all the drugs are taking, as if your doctor isn't the prescribing physician. Otherwise they could be encouraging doctor shopping in order to get the latest and greatest drug.
Agreed on the advertisement stuff. I do think we should go the route of Europe and ban advertising directly to the consumer with regards to prescription drugs.

I will say, the whole "let your doctor know" stuff, I am a little more understanding of. Yes, your primary care may have a record of all your prescription's, but the ER doctor, specialist, anesthesiologist, etc. probably doesnt, unless they all practice under the same umbrella (UNC Healthcare, for example). You would probably be surprised the number of people who cannot tell you what drugs they take on a day to day basis.
packgrad
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Daviewolf83
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Staff
This seems like big news, but there are going to be some very unhappy politicians and news organizations that have been hyping the approval of the Pfizer vaccine for kids 5 and under. Some people had looked at the data and were concerned about its pending approval (see the efficacy data for 2 doses mentioned in the article), based on their analysis. If Pfizer had not withdrawn their application, would the FDA still have approved its use for 5 and under?

Wayland
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Daviewolf83 said:

This seems like big news, but there are going to be some very unhappy politicians and news organizations that have been hyping the approval of the Pfizer vaccine for kids 5 and under. Some people had looked at the data and were concerned about its pending approval (see the efficacy data for 2 doses mentioned in the article), based on their analysis. If Pfizer had not withdrawn their application, would the FDA still have approved its use for 5 and under?



Wow. This is big news. I wonder if that means the advisory meetings next week are cancelled? Or will the agenda change.

I would love to see the FDA analysis that was supposed to drop today... and get the insight into why the request was pulled.

I think they are only pulling it because VRBPAC would have shredded them. Now, the FDA could still have ignored VRBPAC but the optics wouldn't be great (not that that mattered previously).
Daviewolf83
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Wayland said:

Daviewolf83 said:

This seems like big news, but there are going to be some very unhappy politicians and news organizations that have been hyping the approval of the Pfizer vaccine for kids 5 and under. Some people had looked at the data and were concerned about its pending approval (see the efficacy data for 2 doses mentioned in the article), based on their analysis. If Pfizer had not withdrawn their application, would the FDA still have approved its use for 5 and under?



Wow. This is big news. I wonder if that means the advisory meetings next week are cancelled? Or will the agenda change.

I would love to see the FDA analysis that was supposed to drop today... and get the insight into why the request was pulled.

I think they are only pulling it because VRBPAC would have shredded them. Now, the FDA could still have ignored VRBPAC but the optics wouldn't be great (not that that mattered previously).
My hunch is the FDA told Pfizer to withdraw the application, to avoid the potential of it not being recommended by the advisory committee. Pfizer did not make this decision on their own and the FDA likely wanted to avoid the optics of the vaccine's rejection for this age group. It would have cast more doubt with the public as to the efficacy of the vaccine for this age group.
Wayland
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This X1000. If public health had ANY sense whatsoever. And all the damage done to vaccine hesitancy for OTHER vaccines wouldn't have been done.
Daviewolf83
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Reading the comments to the under 5 vaccine on Twitter, there are a lot of people who really suck at science and suck at statistics. They do not understand why we would NOT give a vaccine with low efficacy to children under the age of 5. Here are a couple of my favorites so far:

Quote:

"Dr. Jha, as a parent of 2 children under 5, can you explain what would be the downside now of allowing 2 doses if we KNOW they are safe, and there's a chance they provide some small level of protection against severe illness? TY!"
Quote:

"No, this is not better to wait. We know it's safe and it's effective for 0-2. I can't protect my daughter when everyone is pulling mask mandates or had none to begin with! Stop jerking us parents around FDA and Pfizer."

And my favorite one:
Quote:

"Why not reject outright and up the dose (to 10g)? Safety profile is stellar. Even if not, does the delay make this a potboiler such that even if efficacy is poor on dose 3, pressure to approve?"

Bottom line, we should not approve drugs just because they are safe and only provide marginal increases in protection. Drugs must be both safe AND effective in preventing severe disease for a significant percentage of the population before we decide to put them in someone's body.

The White House, news media, and social media experts got way out in front of this approval. The White House had already approved state's being able to preorder the vaccine, prior to approval. Talking head experts had already primed the pump with parents - getting them excited about a vaccine that was showing some very limited efficacy in its trial. Now you will see tremendous backlash from already frightened parents. It is time for the talking heads to use their platforms to try and talk some of these parents off the ledge and give them a sense of the true risk to their kids.
wilmwolf
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"No, this is not better to wait. We know it's safe and it's effective for 0-2. I can't protect my daughter when everyone is pulling mask mandates or had none to begin with!"

My question for that person would be, if they believe that masks are currently what is protecting their children, why not just have their children continue to wear a mask, mandate or not? I just don't personally get the faith put in a piece of ill fitting cloth.

I very much get that folks want to do everything possible to protect their children from something that could cause them harm, but at this point, that could be said for the vaccine as well as the virus, when dealing with the unknown of long term effects of either. Demanding that they push through approval for use in those ages seems antithetical.
Just a guy on the sunshine squad.
The Gatekeeper.
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StateFan2001 will probably respond to this because he isn't smart enough to understand how ignore works.
Daviewolf83
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wilmwolf80 said:

"No, this is not better to wait. We know it's safe and it's effective for 0-2. I can't protect my daughter when everyone is pulling mask mandates or had none to begin with!"

My question for that person would be, if they believe that masks are currently what is protecting their children, why not just have their children continue to wear a mask, mandate or not? I just don't personally get the faith put in a piece of ill fitting cloth.

I very much get that folks want to do everything possible to protect their children from something that could cause them harm, but at this point, that could be said for the vaccine as well as the virus, when dealing with the unknown of long term effects of either. Demanding that they push through approval for use in those ages seems antithetical.
Exactly. The fact the application was withdrawn is a good example of how "following the science" should work.
statefan91
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wilmwolf80 said:

"No, this is not better to wait. We know it's safe and it's effective for 0-2. I can't protect my daughter when everyone is pulling mask mandates or had none to begin with!"

My question for that person would be, if they believe that masks are currently what is protecting their children, why not just have their children continue to wear a mask, mandate or not? I just don't personally get the faith put in a piece of ill fitting cloth.

I very much get that folks want to do everything possible to protect their children from something that could cause them harm, but at this point, that could be said for the vaccine as well as the virus, when dealing with the unknown of long term effects of either. Demanding that they push through approval for use in those ages seems antithetical.
Do you not think if the 0-2 is showing efficacy and safety that it should be approved?
Wayland
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statefan91 said:

wilmwolf80 said:

"No, this is not better to wait. We know it's safe and it's effective for 0-2. I can't protect my daughter when everyone is pulling mask mandates or had none to begin with!"

My question for that person would be, if they believe that masks are currently what is protecting their children, why not just have their children continue to wear a mask, mandate or not? I just don't personally get the faith put in a piece of ill fitting cloth.

I very much get that folks want to do everything possible to protect their children from something that could cause them harm, but at this point, that could be said for the vaccine as well as the virus, when dealing with the unknown of long term effects of either. Demanding that they push through approval for use in those ages seems antithetical.
Do you not think if the 0-2 is showing efficacy and safety that it should be approved?

But it wasn't showing an efficacy. The whole argument was "we don't think it does much harm and maybe we HOPE that a 3rd dose will work"....

That isn't a great precedent to set for drug approval. What IF the 3rd dose is ALSO ineffective? How about we just wait and ACTUALLY fully conduct the trials.

There have been enough short cuts and over authorizations lately allowing politicians to get out of control.
wilmwolf
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I don't know. I also don't have kids, so ultimately it doesn't really matter what I think Two years worth of data suggests that it is mostly unneeded, but if people are comfortable giving it to their children I don't necessarily oppose that, if it is properly vetted and not just swept through to approval as has been the norm to this point. The fact that the application has been withdrawn should certainly offer pause to those demanding is approval though, in my opinion.
Just a guy on the sunshine squad.
The Gatekeeper.
Homer Dumbarse.
StateFan2001 will probably respond to this because he isn't smart enough to understand how ignore works.
statefan91
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I thought it wasn't showing efficacy for a 2 dose regiment for 3-4 but was for 6 months - 2 based on the initial feedback. https://www.cnn.com/2021/12/17/health/pfizer-vaccine-children/index.html

Quote:

The company decided to add the third dose for all children and babies ages 6 months to 5 years after its independent outside advisers took a look at the data so far.

It showed that two child-sized doses of the Pfizer/BioNtech vaccine were not producing the expected immunity in the 2- to 5-year-olds, although they were doing so for the babies up to age 2.


To that point, I have one child old enough to be vaxxed (they are) and one that isn't old enough. I don't think I would have moved forward with Pfizer if they said you needed the 3 because 2 doses hadn't' displayed enough. Moderna is supposed to be submitting data in March, and both my children already have some level of natural immunity due to prior infection though that was in December 2020.
Wayland
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wilmwolf80 said:

I don't know. I also don't have kids, so ultimately it doesn't really matter what I think Two years worth of data suggests that it is mostly unneeded, but if people are comfortable giving it to their children I don't necessarily oppose that, if it is properly vetted and not just swept through to approval as has been the norm to this point. The fact that the application has been withdrawn should certainly offer pause to those demanding is approval though, in my opinion.

The bar for "needed" was becoming a VERY slippery slope. Having listened to the majority of the ACIP and VRBPAC meetings things were getting out of control.

If you sat in on those first booster advisory meetings and told them;

"Hey. Listen guys, if you approve boosters for everyone, then you are going to see universities MANDATE all their students take them."

I absolutely believe there would have been a lot more restrictions and hard NOs.

Their intent for boosters was really for the old and vulnerable, but they didn't want to limit anyone's personal choice (for some... not speaking for all). And that got warped into BOOSTERS FOR EVERYONE by the politicians. The messaging has been so out of whack for so long and all nuance lost.

This **** needed to get reined in a LONG time ago. This is the FIRST indication IN A LONG TIME that any of the adults in the room have actually spoken up.

When you have people like Paul Offit (who was on the VRBPAC) coming out publicly and saying that he recommended AGAINST his own 20 something son getting a booster, then you know something is off.

All nuance has been lost.

How about we do a trial and figure out what is ACTUALLY going to work for these kids before we say "F it" and medicate them with something that provides no benefit for ****s and giggles?
Wayland
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statefan91 said:

I thought it wasn't showing efficacy for a 2 dose regiment for 3-4 but was for 6 months - 2 based on the initial feedback. https://www.cnn.com/2021/12/17/health/pfizer-vaccine-children/index.html

Quote:

The company decided to add the third dose for all children and babies ages 6 months to 5 years after its independent outside advisers took a look at the data so far.

It showed that two child-sized doses of the Pfizer/BioNtech vaccine were not producing the expected immunity in the 2- to 5-year-olds, although they were doing so for the babies up to age 2.


To that point, I have one child old enough to be vaxxed (they are) and one that isn't old enough. I don't think I would have moved forward with Pfizer if they said you needed the 3 because 2 doses hadn't' displayed enough. Moderna is supposed to be submitting data in March, and both my children already have some level of natural immunity due to prior infection though that was in December 2020.

And if it weren't for the fact that I thought my son was going to be able to get around stupid bureaucratic restrictions, I would have stopped at 1 dose for him because the risk/reward for adolescent boys and the 2nd dose is a coin flip at best. But he got COVID anyways less than 2 months after dose 2.

And then they changed the definition of "up to date/fully vaccinated" anyways.
Daviewolf83
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statefan91 said:

I thought it wasn't showing efficacy for a 2 dose regiment for 3-4 but was for 6 months - 2 based on the initial feedback.

To that point, I have one child old enough to be vaxxed (they are) and one that isn't old enough. I don't think I would have moved forward with Pfizer if they said you needed the 3 because 2 doses hadn't' displayed enough. Moderna is supposed to be submitting data in March, and both my children already have some level of natural immunity due to prior infection though that was in December 2020.
They need to get the trial right and I really do believe the advisory council was set to reject the application, as it had been submitted. Pfizer could always go back and resubmit a new application for 6 months to 2 years, but they will need to make a new submission and this takes time. The current application had to be approved in the form it was submitted.

I do not believe they want to approve a vaccine for 6 months to 2 years and leave a gap for 3-4 year olds. The messaging for that would be troublesome. As well, having the full application rejected would have been very bad, from an vaccine acceptance standpoint. Of course, as we have seen, some people are so desperate, they do not care if it has a low efficacy. My personal opinion is you do not put chemicals into your body on a chance they might work. The efficacy has to be very compelling and provide significantly better protection than having no vaccine and relying on the body's natural defenses.

In the end, Pfizer needs to complete the 3 dose trial and see what the results would suggest. If the efficacy for it is also low, it is possible it could be rejected and there is no approved vaccine. Hopefully, they do find one for this age group to protect those kids who have comorbidities that can put them at a higher risk. For those who are healthy, the decision to vaccinate has to be left up to the parents on the advice of their pediatrician. The politicians need to stop playing doctor and giving medical advice.
statefan91
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You or someone else smarter than me can weigh in, but it seems strange that Pfizer went with the 3mg dose as their only true trial for those age groups, rather than different groups with different dosings like it looked like the 5-12 aged trials included. It seems like that plan has set everything back for the youngest by ~6 months at least.
Wayland
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Daviewolf83
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statefan91 said:

You or someone else smarter than me can weigh in, but it seems strange that Pfizer went with the 3mg dose as their only true trial for those age groups, rather than different groups with different dosings like it looked like the 5-12 aged trials included. It seems like that plan has set everything back for the youngest by ~6 months at least.
In this case, dosing comes down to how the immune system reacts to an unknown pathogen in the body. With younger kids, particularly this age group, it is a question of what is the minimum dose you need for the body to manufacture the spike protein and for the immune system to react. What is the dosing level that provides the best immune response, but does so at the lowest risk of complications and severe reaction?

In this case, it appears a couple of things might have happened:

1) Pfizer may have gotten the dosing wrong, since 3mg likely did not stimulate enough of the spike protein to cause a immune response to the extent it produced antibodies and T/B cells. Your immune system matures over time and what may cause a reaction in younger kids is quite different from what will cause a reaction in older adults. There can be distinct differences for kids aged 6 months of 4 years, versus 5-12 years of age. As I understand it, the age stratification can be quite sharp. The parts of the immune system that are "online" can vary, based on the age of the person.

2) Pfizer may have planned for this to be a 3 dose vaccine all along for his age group. As you know (since you have young kids), infant vaccines are typically given in series and this is for a good reason. The immune system in very young children can forget more quickly, so it needs more reminders. For this reason, it is likely a three or even four dose vaccine schedule may be more appropriate for this age group and the current trial results seem to be showing this to be the case. I think it is likely Pfizer planned for this to be a three dose schedule and were hoping two doses would be sufficient to provide some protection. Apparently, it is not, so more doses (at 3mg) are likely going to be required. I provided the chart below as a reminder as to the multiple doses we all receive to stimulate our body's immune response. Since they already have a 3 dose trial in process, I think this is the more likely explanation.

I also believe it is critical they get the spacing of the dosing schedule right. We know now that the dosing schedule for young males receiving the mRNA vaccines is likely too tight and should be spaced out. Recommendations are now out that spacing should be 8 weeks instead of 3-4 weeks. I mentioned this a couple of months ago and it appears it finally got to a point where the recommendation was changed.

I hope this helps. I do understand the frustration, but it is important they get this right. They can not afford to put a vaccine out that provides little to no protection or one that can cause adverse side-effects, if the increase doses. There is a reason why vaccine trials are complicated and in some cases, can take years to complete.







Werewolf
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So sad that this post is even necessary at this point.

Natural immunity vrs vaccine immunity
https://rumble.com/vunyo5-natural-immunity-vs.-vaccine-immunity.html
#Devolution #Expand Your Thinking #Eye of The Storm #TheGreatAwakening
Oldsouljer
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Packchem91 said:

Mountainman97 said:

For those of you who had it, did you ever get your energy back?
Yes. After just a few days. But I've kept a cough for 4 weeks now.
My wife took longer to get her energy back...a week or so I'd guess.
What you describe for yourself has similarities to what I had in Jan 2020, including the cough that wouldn't go way for four weeks. Never got an antibody test so can't be sure it was Covid, but for one night, I shivered and had muscle spasms. Not like any cold I ever had. Never had an energy issue afterward. Maybe it really was my type O blood, assuming it was Covid in the first place. I assumed it was in hindsight because I'm often around foreign nationals, particularly Chicoms.
Mountainman97
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TheStorm said:

Mountainman97 said:

For those of you who had it, did you ever get your energy back?
Tic. Toc. Tic. Toc. Tic. Toc. ?!?
Dude, just STFU.

Moron.

ETA - I've seen your little posts on here on this subject. Your time is coming.

I don't envy you.
Mountainman97
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Packchem91 said:

Mountainman97 said:

For those of you who had it, did you ever get your energy back?
Yes. After just a few days. But I've kept a cough for 4 weeks now.
My wife took longer to get her energy back...a week or so I'd guess.
Thank you.
Mountainman97
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TheStorm said:

Mountainman97 said:

For those of you who had it, did you ever get your energy back?
Tic. Toc. Tic. Toc. Tic. Toc. ?!?
Double post,

But this ass hat had the audacity to make fun of me for getting sick with COVID?

*** is wrong with him?

Can somebody help me out?
WarrenPeace
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Mountainman97 said:

TheStorm said:

Mountainman97 said:

For those of you who had it, did you ever get your energy back?
Tic. Toc. Tic. Toc. Tic. Toc. ?!?
Double post,

But this ass hat had the audacity to make fun of me for getting sick with COVID?

*** is wrong with him?

Can somebody help me out?



He's not as scared of a little cold as you are?
Mountainman97
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WarrenPeace said:

Mountainman97 said:

TheStorm said:

Mountainman97 said:

For those of you who had it, did you ever get your energy back?
Tic. Toc. Tic. Toc. Tic. Toc. ?!?
Double post,

But this ass hat had the audacity to make fun of me for getting sick with COVID?

*** is wrong with him?

Can somebody help me out?



He's not as scared of a little cold as you are?
You're time's coming with this, along with his. God have mercy on you.
packgrad
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Mountainman97 said:

WarrenPeace said:

Mountainman97 said:

TheStorm said:

Mountainman97 said:

For those of you who had it, did you ever get your energy back?
Tic. Toc. Tic. Toc. Tic. Toc. ?!?
Double post,

But this ass hat had the audacity to make fun of me for getting sick with COVID?

*** is wrong with him?

Can somebody help me out?



He's not as scared of a little cold as you are?
You're time's coming with this, along with his. God have mercy on you.


I don't think many that "haven't had" Covid yet are too concerned about their time "coming". We've heard about it for so long. I have 5 family members with it now. Sniffles for most. A cold is the worst.

Jesus appreciates your mercy though.
packgrad
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You should probably edit your drunk posts. Hate to see you get banned.
Civilized
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packgrad
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Civilized said:




You should see the DMs. He's threatening my wife and mom. Wants to drive from Asheville to Durham to fight. Lol.
Civilized
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LOLOL. I wondered what DM's were flying around behind the scenes. Classy.

Homeboy needs to sleep it off and come back and try again.
packgrad
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Civilized said:

LOLOL. I wondered what DM's were flying around behind the scenes. Classy.

Homeboy needs to sleep it off and come back and try again.


Homeboy shouldn't be welcome back again.
Mountainman97
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packgrad said:

Civilized said:

LOLOL. I wondered what DM's were flying around behind the scenes. Classy.

Homeboy needs to sleep it off and come back and try again.


Homeboy shouldn't be welcome back again.
Lolllllll.

What a ****ing *****. You're scared to death little boy.
Mountainman97
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packgrad said:

Civilized said:




You should see the DMs. He's threatening my wife and mom. Wants to drive from Asheville to Durham to fight. Lol.
Yep. You're a *****.
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