Vaccines and Therapeutics 2.0 & 3.0 Merge

[canpakes]

It's indisputable fact that the vaccines are working.

He doesn’t know why he won’t use the vaccine.

Too much fear porn, maybe. Who knows. Poor guy.

[Jersey Girl]

It's indisputable fact that the vaccines are working.

He doesn’t know why he won’t use the vaccine.

Too much fear porn, maybe. Who knows. Poor guy.

Pick one or more from the following options.

[ ] He's ill or under informed.
[ ] He's unteachable.
[ ] He's simply trolling the thread.

[Gadianton]

Suppose a right-winger out there wishes to prove their repeated claim that the vaccines are totally, 100% ineffective.

medrxiv is just fine as a source for articles to make that case.

So far, the articles housed there and cited as evidence against the vaccines have only substantiated the importance of the vaccines.

Twitter, for instance, is a much lower quality source than medrxiv, but I suppose it's worth an occasional look.

But not even the Twitter feed recently cited makes the case of a very persistent right wing, that the vaccines are ineffective.

[canpakes]

.
The vaccine is badly not working.

It’s not working so badly that it’s doing a great job of protecting vaccinated folks.

If only we could make it not work even more badly, almost everyone would benefit.

[canpakes]

.
Some conclusions from the Washington State Department of Health report of August 18 -

https://www.doh.Washington.gov/Portals/1/Docume ... inated.pdf

• 93.7% of COVID-19 cases from February 1, 2021 – August 10, 2021 were not fully vaccinated

• More than 92% of all cases, hospitalizations, and deaths in individuals 12 years or older from Washington state can be attributed to individuals who have not been fully vaccinated.

[Jersey Girl]

FDA approves Pfizer vaccine!

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Ongoing Safety Monitoring
The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

https://www.fda.gov/news-events/press-a ... 19-vaccine

[Gadianton]

...props for at least finally coming to the realization of how stupid he ended up making himself look.

Yes, concerning the participant who has left for good, never to return, I think this must have been the final motive.

I can understand calling people names and playing social justice super hero, it's silly, but I understand it.

What I didn't understand was the repeated claims that vaccines offer exactly zero protection, and then citing sources that say the opposite, plain as day. I mean, what are the chances that any source is going to claim the vaccines are 100% ineffective, anyway? Lin Wood maybe? Anybody else? And then he would be so angry that a person doesn't purposely misread the source and agree with him. I can understand if his audience were his right-wing friends; there is an expectation to support each other's fantasies and lies. Why would he expect his ideological foes to lie and misread a paper on Covid just because he demands it? I don't think he's so unintelligent that he couldn't see that his sources don't claim what he insisted they did. But that part wasn't trolling, he was really invested in it. He was really desperate to exclaim that nobody will listen to reason, no matter how many resources he links that say the opposite of what he says they say.

I think as you suggest, ultimately he had to admit that he was outclassed in rhetorical skills, and there was no chance of making progress by hyperbole and grossly misrepresenting sources.

[Jersey Girl]

I don't think I can stand much more of this crazy. HOW can people see people like this in the hospital and neighbors dying around them and harp on about their freedom to choose? What on earth has happened to this country when people are under some kind of crazy spell like they are? Believe me when I tell you that I am not a smart person. But when I heard about the vaccines, I did the best that I could to inform myself. I read things that I didn't understand and kept reading them until I thought I understood because I believed my life depended on it, because it DID. When I went for the first shot was I a bit nervous about it? You bet I was, but that didn't stop me!

People talking about fear of side effects? They want a 100% guarantee? TYLENOL has possible side effects. The coffee in your cup has possible side effects!!

On our health department Facebook when the FDA approval was announced, now there are people claiming the FDA is corrupt. It's just one excuse after another and the people on camera (like in the interviews linked below) look like they're eyes are glazed over as they tell you that everyone has the right to choose and rave on about their freedom.

I can almost take it from younger folks who don't know a world without vaccines, but from the older folks? Are you kidding? What on earth has gotten into them? Politicians? Who in the hell trusts politicians to tell the truth? One person in the interviews below claimed that we had our own God given antibodies or something. Does she not realize that we build up antibodies from getting SICK??? Does she even hear herself and how stupid she sounds?

Is it that these people like to think they are part of a powerful movement? This movement leads to the GRAVE. This is empowering?

We've tried educating them. We've tried talking to them. Shouting at them. Shaming them. We've tried PAYING them for god sakes. Can't they SEE what is in front of their very eyes?

Honestly, I feel myself needing to look away from all of this stuff. How in the world can you compete with crazy?

I thank the God that I believe exists for the scientific community and the people who volunteered as candidates for the clinical trials. Seriously what is wrong with people that they don't recognize the GIFT of these vaccines? Will they reject the new studies that are being conducted for other mRNA vaccines? When will they SEE that they are living in a world of exciting scientific innovation and transformation?

I don't know how to deal with this vaccine hesitancy any more. I really do not. It's morbid. It's sick. It's like they're all drugged and out of their minds. It's surreal.


Dying in the Name of Vaccine Freedom | NYT Opinion
https://www.youtube.com/watch?v=pd8P12BXebo

[Atlanticmike]

JERSEY SAID ""We've tried educating them. We've tried talking to them. Shouting at them. Shaming them. We've tried PAYING them for god sakes. Can't they SEE what is in front of their very eyes?

Honestly, I feel myself needing to look away from all of this stuff. How in the world can you compete with crazy?

I thank the God that I believe exists for the scientific community and the people who volunteered as candidates for the clinical trials. Seriously what is wrong with people that they don't recognize the GIFT of these vaccines? Will they reject the new studies that are being conducted for other mRNA vaccines? When will they SEE that they are living in a world of exciting scientific innovation and transformation?

I don't know how to deal with this vaccine hesitancy any more. I really do not. It's morbid. It's sick. It's like they're all drugged and out of their minds. It's surreal.""

And there you have it!! A statement from a spoiled, self absorbed, brat that thinks that "THEY" have done everything "THEY" can to help the poor little dumb people that unfortunately have to exist at the same time she does on Earth! For Christ sake!! Grow up!!

Here let me show you the key words in your last post that shows you think you're better than everyone else! """CRAZY, HARP ON ABOUT THEIR FREEFOM,. SOME KIND OF CRAZY SPELL,. ONE EXCUSE AFTER ANOTHER,. THEIR EYES ARE GLAZED OVER, WHAT ON EARTH HAS GOTTEN INTO THEM,. HOW STUPID SHE SOUNDS,. THESE PEOPLE,. WE'VE TRIED EDUCATING THEM,. SHOUTING AT THEM, SHAMING THEM, WE'VE TRIED PAYING THEM FOR GOD SAKES. CAN'T THEY SEE WHAT'S IN FRONT OF THEIR EYES,. HOW CAN YOU COMPETE WITH CRAZY, WHAT IS WRONG WITH PEOPLE, WHEN WILL THEY SEE, IT'S LIKE THEY'RE ALL DRUGGED AND OUT OF THEIR MINDS.""" You just don't get it do you? YOU are the problem, your self absorbed attitude is the problem. You're never going to convince people to take the vaccine demeaning them and putting them down every chance you can get. It's what I call the backfire effect. You're contributing to it and so is all your crazy liberal friends. Also, you do realize a certain percentage of liberals have a fear of the vaccine? The people I know who haven't taken the vaccine are all Democrats. I have I guy that picks up debree for me that I've known since I was a young kid. One of the nicest men I know. He's a very old black guy that is healthy as an ox. The kind of guy that still wears a one piece underwear the old timers used to wear, then long pants and a long sleeve shirt, everyday, no matter the temperature, it could be 105 degrees and he's still dressed the same way. He's driven the same vehicle since 1976. Eaten they same food since forever, never, and I mean never tries different food than what has worked for him. Doesn't use deodorant. Only a certain kind of soap. You ever met an old timers like this?? They are great people!! A treasure trove of information. He's inspired me probably more than any other man I know. His whole family is life long Democrats and none of them have taken the vaccine and WILL NOT TAKE IT NO MATTER WHAT!! They're very cautious about the white people they trust. For the guy I described it has to do with the Tuskegee project and other factors. I'm talking about a family of like 30 to 40 people combined.

The way you described the people who won't take the vaccine is unbelievable. Almost as if you have absolutely no heart. there's all kinds of reasons people won't take the vaccine most of them are out of fear. If you're that scared to be around certain people, wear your mask, exercise as much as you can, make sure you're at your correct weight for your size, eat a very sensible diet, don't smoke, don't drink alcohol, get a booster shot when it becomes available. But for Christ's sake, please stop trying to shame people into what you believe is correct for them to believe!!

[Lem]

I don't think I can stand much more of this crazy. HOW can people see people like this in the hospital and neighbors dying around them and harp on about their freedom to choose? What on earth has happened to this country when people are under some kind of crazy spell like they are? Believe me when I tell you that I am not a smart person. But when I heard about the vaccines, I did the best that I could to inform myself. I read things that I didn't understand and kept reading them until I thought I understood because I believed my life depended on it, because it DID. When I went for the first shot was I a bit nervous about it? You bet I was, but that didn't stop me!

People talking about fear of side effects? They want a 100% guarantee? TYLENOL has possible side effects. The coffee in your cup has possible side effects!!

On our health department Facebook when the FDA approval was announced, now there are people claiming the FDA is corrupt. It's just one excuse after another and the people on camera (like in the interviews linked below) look like they're eyes are glazed over as they tell you that everyone has the right to choose and rave on about their freedom.

I can almost take it from younger folks who don't know a world without vaccines, but from the older folks? Are you kidding? What on earth has gotten into them? Politicians? Who in the hell trusts politicians to tell the truth? One person in the interviews below claimed that we had our own God given antibodies or something. Does she not realize that we build up antibodies from getting SICK??? Does she even hear herself and how stupid she sounds?

Is it that these people like to think they are part of a powerful movement? This movement leads to the GRAVE. This is empowering?

We've tried educating them. We've tried talking to them. Shouting at them. Shaming them. We've tried PAYING them for god sakes. Can't they SEE what is in front of their very eyes?

Honestly, I feel myself needing to look away from all of this stuff. How in the world can you compete with crazy?

I thank the God that I believe exists for the scientific community and the people who volunteered as candidates for the clinical trials. Seriously what is wrong with people that they don't recognize the GIFT of these vaccines? Will they reject the new studies that are being conducted for other mRNA vaccines? When will they SEE that they are living in a world of exciting scientific innovation and transformation?

I don't know how to deal with this vaccine hesitancy any more. I really do not. It's morbid. It's sick. It's like they're all drugged and out of their minds. It's surreal.


Dying in the Name of Vaccine Freedom | NYT Opinion
https://www.youtube.com/watch?v=pd8P12BXebo

Good point about everything having side effects. Including the topical animal medication apparently some people take internally. Taking a chance on stuff like that, but ruling out a vaccine as too risky is not very rational.