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Member Run Boards >> Coronavirus >> Why Aren’t the Vaccines Approved?
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Message started by Sir lastnail on Aug 13th, 2021 at 11:20am

Title: Why Aren’t the Vaccines Approved?
Post by Sir lastnail on Aug 13th, 2021 at 11:20am
Yeh we are always told to take the jab and they are so good and so safe so why aren't they approved ??

https://www.nytimes.com/2021/07/21/briefing/covid-vaccines-fda-approval.html



Quote:
Why Aren’t the Vaccines Approved?
The F.D.A. is encouraging people to get a Covid-19 shot — but hasn’t formally approved those vaccines.

It is the most discordant part of the U.S. government’s response to Covid-19.

Even as President Biden, the C.D.C. and virtually the entire scientific community are urging — pleading with, even — Americans to get vaccinated, the government has not formally approved any vaccine. The Food and Drug Administration has instead given only “emergency use authorization” to the shots from Moderna, Pfizer and Johnson & Johnson. That’s a temporary form of approval that allows people to receive shots while the agency continues to study their effectiveness and safety.

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The difference between emergency authorization and full approval matters. Right now, the military, schools and other organizations cannot easily require vaccinations. The “lack of F.D.A. licensure leave schools, colleges, businesses in a legal quandary,” Dr. Jerome Adams, a former surgeon general, recently wrote. Adams argued that lives were at stake and that the issue should be receiving more media coverage than it has.

The situation also feeds uncertainty and skepticism among some Americans who have not yet gotten a shot. Those skeptics, as Matthew Yglesias of Substack wrote yesterday, are effectively taking the F.D.A. at its word. The F.D.A. leaders’ official position is that “they don’t have enough safety data yet,” Yglesias noted.

The strangest part of all this is that the F.D.A.’s official position does not reflect its leaders’ actual views: They agree with the C.D.C. and other scientists that Americans should be getting vaccinated as soon as possible.

Dr. Janet Woodcock, the F.D.A.’s acting commissioner, has said that the F.D.A. “conducted a rigorous and thorough review” of the vaccines before allowing them to be given to people and that the Pfizer vaccine “meets F.D.A.’s high standards for safety and effectiveness.” She also said, “Getting more of our population vaccinated is critical to moving forward and past this pandemic.”

Hurry up and wait

Why, then, hasn’t the F.D.A. taken the final step of formal approval?

It is following a version of its traditional, cautious process for vaccine approval. That process has historically had some big advantages, reducing the chances that Americans end up taking a faulty drug. To move much more quickly would risk undermining the public’s confidence in the F.D.A. and, by extension, the medicines it approves, Dr. Peter Marks, who oversees the process, has argued.

But I think the F.D.A.’s leaders have failed to understand how most Americans really think about the vaccines. It is different from the way that scientists and epidemiologists do. It’s less technical and based more on an accumulation of the publicly known facts.

It reminds me of another example of expert miscommunication, early in the pandemic. Back then, public health officials made highly technical statements about masks that many people interpreted as discouragement from wearing them. These statements ignored the many reasons to believe that masks could make a difference (like their longtime popularity in Asia to prevent the spread of viruses) and focused instead on the absence of studies showing that masks specifically prevented the spread of Covid.

Later, officials insisted that they were merely “following the data.” In truth, though, they were basing their advice on a narrow reading of the data — and not understanding how most people would interpret their comments.

The long wait to approve the vaccines is similar. F.D.A. officials are acting as if most Americans are experts in the nuances of their approval process and will be shocked if the agency expedites it. In reality, many Americans know almost nothing about that process. But some are understandably confused by the mixed messages that the F.D.A. is sending.

Hundreds of millions of people around the world have been vaccinated. Tens of thousands of them were followed for months in clinical trials. And F.D.A. officials have repeatedly urged other Americans to get vaccinated. “In the history of medicine, few if any biologics (vaccines, antibodies, molecules) have had their safety and efficacy scrutinized to this degree,” Dr. Eric Topol of Scripps Research wrote in The Times.



Title: Re: Why Aren’t the Vaccines Approved?
Post by Sir lastnail on Aug 13th, 2021 at 11:21am

Quote:
Big costs, few benefits

Think of it this way: In the highly unlikely event that the evidence were to change radically — if, say, the vaccines began causing serious side effects about 18 months after people had received a shot — Americans would not react by feeling confident in the F.D.A. and grateful for its caution. They would be outraged that Woodcock and other top officials had urged people to get vaccinated.

The combination means that the F.D.A.’s lack of formal approval has few benefits and large costs: The agency has neither protected its reputation for extreme caution nor maximized the number of Americans who have been protected from Covid. “In my mind, it’s the No. 1 issue in American public health,” Topol told me. “If we got F.D.A. approval, we could get another 20 million vaccinated,” he estimated.

Rebecca Robbins, who covers the vaccines for The Times, says she is less sure about the size of the impact. But she agrees that full approval, whenever it happens, is “probably going to be the catalyst for many new mandates.”

My colleague Noah Weiland says: “Right now, it appears a full approval for the Pfizer vaccine could come in September, with Moderna not far behind.”

In the meantime, more Americans may get sick from Covid. About 34 percent of Americans who are eligible for the vaccines have not yet gotten a shot. The number of new cases has roughly tripled this month, largely because of the Delta variant. The number of deaths has almost doubled in the past two weeks.

If you want to read the F.D.A.’s explanation, I recommend a letter Marks wrote to The Times: “We want to assure the public that the review of applications for full approval of Covid-19 vaccines is one of the highest priorities at the Food and Drug Administration.”

Title: Re: Why Aren’t the Vaccines Approved?
Post by John Dillermand on Aug 13th, 2021 at 11:34am
Glad we live in Australia where the TGA did approve them. FMD.

Title: Re: Why Aren’t the Vaccines Approved?
Post by greggerypeccary on Aug 13th, 2021 at 11:35am

Sir lastnail wrote on Aug 13th, 2021 at 11:20am:
Yeh we are always told to take the jab and they are so good and so safe so why aren't they approved ??


I guess they're just doing the final tweaks on the chips that get implanted under your skin with the jab.

They have to be synced up with the 5G towers.

Once that's done, I'm sure the vaccines will be approved.


Title: Re: Why Aren’t the Vaccines Approved?
Post by JaSin. on Aug 13th, 2021 at 11:45am
Highly infected world says...


Look at those whinging self-indulgent Australians with hardly any infections and leading economy in the world cry for our much needed Vaccines.

Australia: Minimal infection: Crying "Me First!" for vaccines.
World: Highly infected: having to send Vaccines to whinging Australians.



Title: Re: Why Aren’t the Vaccines Approved?
Post by Sir lastnail on Aug 13th, 2021 at 3:10pm

John Dillermand wrote on Aug 13th, 2021 at 11:34am:
Glad we live in Australia where the TGA did approve them. FMD.


How much kick back did they get ?? :D LOL

Title: Re: Why Aren’t the Vaccines Approved?
Post by Sir lastnail on Aug 13th, 2021 at 3:11pm

greggerypeccary wrote on Aug 13th, 2021 at 11:35am:

Sir lastnail wrote on Aug 13th, 2021 at 11:20am:
Yeh we are always told to take the jab and they are so good and so safe so why aren't they approved ??


I guess they're just doing the final tweaks on the chips that get implanted under your skin with the jab.

They have to be synced up with the 5G towers.

Once that's done, I'm sure the vaccines will be approved.



more likely they are doing their final tweaks on stupid people like yourself who blindly take their unproven sh.t :D LOL

Title: Re: Why Aren’t the Vaccines Approved?
Post by Carl D on Aug 13th, 2021 at 3:18pm

greggerypeccary wrote on Aug 13th, 2021 at 11:35am:
I guess they're just doing the final tweaks on the chips that get implanted under your skin with the jab.

They have to be synced up with the 5G towers.

Once that's done, I'm sure the vaccines will be approved.


I read somewhere the other day that some idiots believe the chips injected with the vaccine will turn you into a 5G mobile hotspot. :D :D

I'll just settle for a 4G one seeing as my mobile 4G reception with Vodafone is pretty abysmal where I live here. I need to have the phone set to 3G when I'm home.

Plus, I'd need to buy a new phone to use 5G, I'll have to specify a 4G chip with my second Covid vaccination next month. ;D ;D

Title: Re: Why Aren’t the Vaccines Approved?
Post by chimera on Aug 13th, 2021 at 3:22pm
So does your phone bill go down?  Mine has since I started getting ringing in my ears.

Title: Re: Why Aren’t the Vaccines Approved?
Post by John Dillermand on Aug 13th, 2021 at 5:12pm

Sir lastnail wrote on Aug 13th, 2021 at 3:10pm:

John Dillermand wrote on Aug 13th, 2021 at 11:34am:
Glad we live in Australia where the TGA did approve them. FMD.


How much kick back did they get ?? :D LOL


None. Its a government agency. Learn your facts you pilled halfwit.

Title: Re: Why Aren’t the Vaccines Approved?
Post by Karnal on Aug 13th, 2021 at 5:56pm

Sir lastnail wrote on Aug 13th, 2021 at 3:11pm:

greggerypeccary wrote on Aug 13th, 2021 at 11:35am:

Sir lastnail wrote on Aug 13th, 2021 at 11:20am:
Yeh we are always told to take the jab and they are so good and so safe so why aren't they approved ??


I guess they're just doing the final tweaks on the chips that get implanted under your skin with the jab.

They have to be synced up with the 5G towers.

Once that's done, I'm sure the vaccines will be approved.



more likely they are doing their final tweaks on stupid people like yourself who blindly take their unproven sh.t :D LOL


Either that, or they're approved.

Which one would you like to go with, dear?

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