Coronavirus Thread: Worldwide Pandemic

[ADevilYouKhow]

The dems are dropping the ball

voters will remember these draconian lock downs

desantis is doing all the right things

desantis flanking Dems from the left

 

[BK The Great]

shyt been in development since the sars outbreak. Just what exactly haven’t you had answers yet - what questions are you searching that you still don’t understand? How long does it need to exist before you feel comfortable with it?

Then what's the hold up of approving the damn thing?

Just admit you're full of shyt and trolling

Listen it's a person's choice to take it. There's still a 100 Million people who haven't took it. Can't be mad at me Ain't nothing wrong with being skeptical of this entire rollout. Again, i'm not mad at no one taking this thing.

 

[dora_da_destroyer]

Then what's the hold up of approving the damn thing?






Listen it's a person's choice to take it. There's still a 100 Million people who haven't took it. Can't be mad at me Ain't nothing wrong with being skeptical of this entire rollout. Again, i'm not mad at no one taking this thing.

I mean, I wish I could find the documentary I watched about the FDA - but FDA approval means absolutely shyt regarding safety, these pharma companies pay their way thru their process all the time. I also dated a guy who worked for the FDA some years back and even he corroborated that the FDA is shady, so if that’s the stamp of approval you’re waiting for

 

[BK The Great]

I mean, I wish I could find the documentary I watched about the FDA - but FDA approval means absolutely shyt regarding safety, these pharma companies pay their way thru their process all the time. I also dated a guy who worked for the FDA some years back and even he corroborated that the FDA is shady, so if that’s the stamp of approval you’re waiting for

So what's the point of the FDA existing if they doing shady business? It's all about money then.

 

[dora_da_destroyer]

So what's the point of the FDA existing if they doing shady business? It's all about money then.

Exactly...which is why I don’t see this whole “it needs to be fully approved” as a good line of reasoning when we have countless examples of drugs that were fully approved that were anywhere from ineffective to outright deadly.

 

[BK The Great]

Exactly...which is why I don’t see this whole “it needs to be fully approved” as a good line of reasoning when we have countless examples of drugs that were fully approved that were anywhere from ineffective to harmful.

Well that's what others are waiting on as well. Or maybe they just don't want to take it all together. It still seems a bit shady to begin with. Everyone is in the dark now as far as this whole pandemic is concerned.

 

[88m3]

If you can’t see his obviously associated with (insert evil political group) and making boatloads of money through (insert evil organization) I don’t know what to tell you

Fauci is Neoliberal and is saying the things he's saying to bankroll coups in socialist countries. This is all about money, neoliberalism, and power.

 

[88m3]

Concern grows over rise of respiratory virus and Delta infections among children.


Health officials are concerned about a simultaneous rise in Delta coronavirus infections and cases of a respiratory virus known as respiratory syncytial virus, or RSV — a highly contagious, flulike illness, that is typically more likely to affect children and older adults.


dudes keep playing around and tempting fate though

 

[Macallik86]

Random/unrelated. I feel like there are two types of unvaxxed camps at this point. There are people who are extremely on the fence about things but can be persuaded, and there are people that just keep moving the goal posts from conspiracy theory to conspiracy theory.

I can't tell if vaxxed people underestimated the people on the fence, or if people are shifting their POV as people around them are dropping. Either way, similar to low-information voters who have had their head buried in the sand, there are people out there that, despite it being late AF in the game, can be nudged in the right direction. Please keep that in mind as you engage with people in your daily. (This doesn't apply to people who are unvaxxed yet continuously posting in a thread about a pandemic... Olympic levels of cognitive dissonance there, I swear...)

 

[Pressure]

You wanted the shot so why do you gotta be mad at someone for not following suit? Neg or not, people are aware it’s a experimental shot and people are still skeptical. I’m not anti vaccine but I’m questioning what is going on here.

We all see what's going on here, buddy

 

[88m3]

Louisiana hospitals reach capacity as COVID-19 cases surge

 

[BK The Great]

We all see what's going on here, buddy

Ain’t it true though?

 

[nyknick]

Then what's the hold up of approving the damn thing?

After emergency use authorization to get full approval it needs to go through BLA. Which as @dora_da_destroyer said is there to hold the up the damn thing. It takes multiple years to get certain drugs approved.

To get EUA they needed to get through 3 phases of clinical testing which proved their safety. But if that isn't satisfactory for you, since then over 180 million Pfizer shots were administered in US and multiple peer reviewed studies have been done across multiple countries. That makes it more scrutinized and studied drug than anything that had to go through FDA's years long approval process.

FDA doesn't have the luxury to fukk around and take their sweet time with the process when it comes to covid so they already prioritized reviewing vaccines and they will fully approve them by January 2022 the latest. Pfizer is expected to get full approval by end of September this year, they applied for full approval in May but have been submitting necessary documents to FDA since 2020.

Reddit comment about BLA application:

Spoiler

Now to have full approval, and under normal circumstances, the vaccine makers have to get full approval through a Biologics License Application (BLA) submitted to the Food and Drug Administration. This is a 3-stage process.

The BLA application itself includes:

• Applicant information
  
  
• Product/Manufacturing information
  
  
• Pre-clinical studies
  
  
• Clinical studies
  
  
• Labeling

1. They schedule a bioresearch monitoring inspection. FDA comes out to inspect the production process and facilities.
   
   
2. Then they file a Form FDA 356th which includes:

• A summary of information submitted as part of the application.
  
  
• Information on the applicant submitting the biologics license application.
  
  
• A preclinical data section.
  
  
• A clinical data section that includes safety and efficacy data on the product.
  
  
• Draft labeling of the product to be licensed.
  
  
• Information on the manufacturing, chemistry, and controls of the product.
  
  
• A data summary of validation of important processes and assays involved in the manufacture of the product.
  
  
• A description of the facility where the product is manufactured.
  
  
• Case report form tabulations on the manufacturer’s clinical experience with the product.
  
  
• Case report forms and serious event narratives.
  
  
• An index.

1. Then we wait for the FDA review. This can take as much time as it needs to take.

Sources:

The Biologics License Application (BLA) Process Explained

Emergency Use Authorization for Vaccines Explained

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine | pfpfizeruscom

 

[BK The Great]

After emergency use authorization to get full approval it needs to go through BLA. Which as @dora_da_destroyer said is there to hold the up the damn thing. It takes multiple years to get certain drugs approved.

To get EUA they needed to get through 3 phases of clinical testing which proved their safety. But if that isn't satisfactory for you, since then over 180 million Pfizer shots were administered in US and multiple peer reviewed studies have been done across multiple countries. That makes it more scrutinized and studied drug than anything that had to go through FDA's years long approval process.

FDA doesn't have the luxury to fukk around and take their sweet time with the process when it comes to covid so they already prioritized reviewing vaccines and they will fully approve them by January 2022 the latest. Pfizer is expected to get full approval by end of September this year, they applied for full approval in May but have been submitting necessary documents to FDA since 2020.

Reddit comment about BLA application:

So it’s gonna take forever then.

 

[nyknick]

So it’s gonna take forever then.

Let me check

End of September is just two month away