Originally Posted by Decadeofdave

I am not a doctor, but I stayed at a Holiday Inn express last night ---
It would seem to me that full FDA approval of the original vaccine should be done first, before a booster of this emergency vaccine is ready.

The FDA has collected the six months of data needed for full approval. Nothing adverse in the data but seems to be some delay is getting the recommendation finalized.

Originally Posted by drducat

Pfizer has postponed Boosters.....I do believe they have an ADE problem on their hands and trying to get ahead of it.

Have not heard of Pfizer’s issue but so far an ADE problem in the existing vaccines has not developed.
———————————————

Neither COVID-19 disease nor the new COVID-19 vaccines have shown evidence of causing ADE. People infected with SARS-CoV-2, the virus that causes COVID-19, have not been likely to develop ADE upon repeat exposure. This is true of other coronaviruses as well. Likewise, studies of vaccines in the laboratory with animals or in the clinical trials in people have not found evidence of ADE.

[MDLNB]

My daughter's cardiologist told her that he was vaccinated and still ended up in the hospital with COVID. He suggested that since she had already had the virus earlier that she should NOT get vaccinated. I'm just throwing that out since everyone seems to throw out all those deathly ill folks and deaths they insist on telling us about. Not that I am suggesting that this is not serious. I am just passing it on as another thought for some to think about. Personally, I was surprised to hear of any physician suggesting NOT getting a vaccination.
If my vaccination is only good for six months, I am thinking of taking my chances without a booster. I went a year without the vaccination. My choice and I figure that if anyone else is worried about me carrying the virus and exposing them, then they can wear a mask around me. They do not have to visit me if they are afraid, and I believe in social distancing anyway.

Originally Posted by drducat

How does one accelerate the process to fully approve the Pfizer-BioNTech COVID-19 vaccine? It take time not speed...........

The required six months of data collection has been completed for full FDA approval and no adverse issues. Seems a bottleneck in issuing the report which could remove vaccine hesitancy.

[drducat]

Originally Posted by John41

Have not heard of Pfizer’s issue but so far an ADE problem in the existing vaccines has not developed.
———————————————

Neither COVID-19 disease nor the new COVID-19 vaccines have shown evidence of causing ADE. People infected with SARS-CoV-2, the virus that causes COVID-19, have not been likely to develop ADE upon repeat exposure. This is true of other coronaviruses as well. Likewise, studies of vaccines in the laboratory with animals or in the clinical trials in people have not found evidence of ADE.

The longer they wait the better outcome.

[Escape Artist]

Originally Posted by John41

Have not heard of Pfizer’s issue but so far an ADE problem in the existing vaccines has not developed.
———————————————

Neither COVID-19 disease nor the new COVID-19 vaccines have shown evidence of causing ADE. People infected with SARS-CoV-2, the virus that causes COVID-19, have not been likely to develop ADE upon repeat exposure. This is true of other coronaviruses as well. Likewise, studies of vaccines in the laboratory with animals or in the clinical trials in people have not found evidence of ADE.

What is ADE?

[drducat]

Originally Posted by Escape Artist

What is ADE?

Antibody-dependent enhancement

[asianthree]

So immune comprised, patient in active chemo, or have a organ transplant. That is what was announced to us this morning, for guidelines for booster. At this time just because you think you need a booster, it’s not in the mix.
No exact date released, as of this morning to us. Our small group is over 26,000, and estimated those who possibly qualify will be less than 1%. But not taking into account those who have not had vaccine, or only one dose.
So I am very happy, I don’t qualify.

[coffeebean]

Originally Posted by drducat

Pfizer has postponed Boosters.....I do believe they have an ADE problem on their hands and trying to get ahead of it.

Pfizer or Moderna vaccines do not have an ADE problem. There is no evidence of this and I wonder where you get your information from?

Do the mRNA vaccines cause Antibody Dependent Enhancement (ADE) with COVID-19 disease? | Immunize BC

[drducat]

Originally Posted by coffeebean

Pfizer or Moderna vaccines do not have an ADE problem. There is no evidence of this and I wonder where you get your information from?

Do the mRNA vaccines cause Antibody Dependent Enhancement (ADE) with COVID-19 disease? | Immunize BC

Are you sure of that...the link is false...mRna vaccines never made it past animal trials. Most experienced Cytokine Storms when re-infected and died. It is a real thing. They are not sure about the human trial you are in.

[gdennis317]

Originally Posted by John41

Moderna is finalizing data on several booster shots for Covid 19 and urges elderly populations such as The Villages to get a booster shot to avoid respiratory complications. The efficacy of the first two shots diminishes after 6 to 9 months. We got our second shot in March 2021 so about November we will sign up for the booster. Moderna is a vaccine company that developed a vaccine against Covid 19 last year under Operation Warp Speed.

They may have boosters available then, but Moderna Executive said today that they do not know when it will be needed. He stated MAYBE by this winter.

He went on to state that Tests so far, based on cases, show Moderna still about 93% effective after six months, so has diminished only a couple of percentage points. Majority of even the more elderly people have only been covered for six months or less.

All speculation at this point.

[OrangeBlossomBaby]

Originally Posted by Bill14564

This sounds like the same marketing pitch Pfizer made within the last two months.

It will be interesting to see the studies that show not only that the antibodies are falling off but the level of antibodies needed to still be protected. There may be fewer antibodies today than nine months ago but if the level is still far above what is needed for protection against the virus then getting a booster is just putting money into the manufacturer's pocket.

It's not "within the last two months." Pfizer said from the very start of their development that they wouldn't know how long the vaccines would last, and this was part of the process. There was a big to-do when it passed the six-month mark and they said it was holding firm, but that they STILL didn't know how long it would remain as effective. Moderna said the same, and so did J&J.

We all knew that there was a distinct possibility there'd be a need for a booster, or even a vaccine every year indefinitely. It was always a possibility and no one ever tried to hide this from anyone, it was well-publicized.

Part of the problem is that the vaccine wasn't administered to the majority. If the majority had been vaccinated, the virus possibly wouldn't have lasted long enough to need a booster. It would've possibly died out. But since the majority isn't vaccinated, we'll never know for sure. And so we're in the situation we're in now.

[coffeebean]

Originally Posted by drducat

Are you sure of that...the link is false...mRna vaccines never made it past animal trials. Most experienced Cytokine Storms when re-infected and died. It is a real thing. They are not sure about the human trial you are in.

Here is another source. Still, no evidence of ADE with mRNA vaccines........
Antibody-dependent Enhancement (ADE) and Vaccines | Children's Hospital of Philadelphia

Here is one more that refutes ADE with mRNA vaccines.........
Are COVID-19 vaccines causing antibody-dependent enhancement?

[drducat]

Originally Posted by coffeebean

Here is another source. Still, no evidence of ADE with mRNA vaccines........
Antibody-dependent Enhancement (ADE) and Vaccines | Children's Hospital of Philadelphia

Here is one more that refutes ADE with mRNA vaccines.........
Are COVID-19 vaccines causing antibody-dependent enhancement?

Here is one from the NIH.

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease - PubMed

"Conclusions drawn from the study and clinical implications: The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent."

[Bill14564]

Originally Posted by OrangeBlossomBaby

It's not "within the last two months." Pfizer said from the very start of their development that they wouldn't know how long the vaccines would last, and this was part of the process. There was a big to-do when it passed the six-month mark and they said it was holding firm, but that they STILL didn't know how long it would remain as effective. Moderna said the same, and so did J&J.

We all knew that there was a distinct possibility there'd be a need for a booster, or even a vaccine every year indefinitely. It was always a possibility and no one ever tried to hide this from anyone, it was well-publicized.

Part of the problem is that the vaccine wasn't administered to the majority. If the majority had been vaccinated, the virus possibly wouldn't have lasted long enough to need a booster. It would've possibly died out. But since the majority isn't vaccinated, we'll never know for sure. And so we're in the situation we're in now.

My mistake. It was not "within the last two months," it was 28 days ago.

There was always the possibility that boosters would be necessary but on July 9 it was reported that Pfizer intended to request approval for a booster after six months. The FDA and CDC pushed back.