Seems like with all these data coming in on its safety issues, it would or could never get approved, which is what I want as it appears to be a death shot.
I assume they would do BS fuckery with the numbers to push through for approval.
But if it were judged like a 'regular' vaccine, could it ever be approved?
I worry if they push for approval, they will push it on everyone including the kids.
I've been involved in getting a medical product FDA approval before. It takes years. It took us ~5 years from finished product already in phase two clinical trials to approval. The bureaucracy in the system is so ridiculous I am fairly certain it was designed to keep us from advancing medicine.
For these vaccines, they are illegally EUA, so how likely is they could be approved tomorrow? Exactly as likely as whoever is running the show wants it to be. There is nothing standard about this.
Why do you say "Illegally EUA?" This could be a good red pill.
The law shows, the vaccine is not allowed to be used for emergency use if there is a viable treatment available.
"(c)Criteria for issuance of authorization ...
(3)that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition;"
These studies show that there are numerous treatments available for Covid-19. These are metadata analyses which include in total links to hundreds of studies and journal papers that have looked into the efficacy of Ivermectin, Hydroxychloroquine, Vitamin D and many other treatments (tabs at the top of page for meta analysis on each treatment type, each one containing links to many independent studies). By all available data these treatments have higher efficacy than the vaccines. All of these have been proven far past the level the vaccine has in all categories of numbers, tests, efficacy and safety.
Back in 2020 HCQ was being reported as the worst thing ever. This was fundamental in getting the vaccine an EUA. Of course in 2005 they knew it was a viable treatment for SARS, but in 2020 they said it would kill people. Here is a report with links to a paper that shows that a study done in March 2020 was using a potentially lethal dosage of HCQ which will have almost certainly skewed the results of the tests.
From the paper:
"A loading dose is important because of the large volume of distribution. The loading dose will be 800 mg, administered 6-hourly,until 2 doses have been administered. Subsequently, starting 12 hours after the first loading dose,the dose will be 400 mg administered 12-hourly for 12 doses"
That is 2400 mg in 24 hours.
This shows the recommended dosages for HCQ. The maximum dose for a single day is half that, most are 1/6th. At the very least these extreme dosages skewed the results on this "failure" of HCQ in the beginning of the testing. At worst such high dosages caused overdose related death or injury in the sick people it was used in.
Since there are viable treatments available, the EUA is illegal. They are not "approved" treatments, but they have far exceeded the standard of proof of approval by any standard, and far, far above the vaccines in use. They all have decades of safety usage and are considered among the safest (and best) medications known to man for numerous other infection type diseases.
Oh! I didn't know the rule for there being "no adequate, approved, and available alternative to the product..." applied to Emergency Use Authorization. For some reason, I was thinking this only applied to FDA-approved vaccines. Wow, this is really a game-changer.
Thanks for the info, fren!
The FDA is in on the agenda. They have violated their own standards by approving any of the vaccines as well as the CDC.
So they are war criminals. Like Dr. Mengele.
Listen, THE WHOLE FED GOVT APPARATUS IS COMP'D AND THEREFORE, BROKE BEYOND REPAIR.
In Naval Aviation, when an item is broke beyond repair, it's called BCM, Broken Cannot Maintain. When this happens, that item gets destroyed and thrown away, or sent back to the manufacturer to ascertain why. The Fed Govt, Legislature, Judicial Branch, etc is BCM now. And since we can't just send it back to the manufacturers any more, we must destroy the item and remake a better version.
Exactly what is about to happen to the medical/nursing field. This is where I plan to MAKE A DIFFERENCE!
Also in Naval Aviation, most aviators would rather have the equivalent weight in extra fuel than democrats onboard.
Still not getting vaxaclotted, approved or not. Wouldn't be prudent.
Yes I’m certainly not getting it nor are my kids. I just see writing on the wall and they plan on making it difficult for us holdouts.
It depends upon the bribe offer meeting the reserve price.
I think it is unlikely. How do they sweep all the dead people under a rug? If they do, social media will be forced to stop censoring a moment later. Mandated FDA approved death shots + total censorship = Revolutionary War 2.0. If patriots are in control, it will be mitigated somehow.
Im researching and seeing all these MSM stories on Approval in 2022 like it's a done deal or something. I'm like "WTF? these vaccines are poison, are they out of their minds?"
They're trying to groom ppl into thinking it's inevitable. But they're going to overplay their hand and get some nasty pushback.
How they going to explain it this fall when the common cold starts killing all the people who took the vaccine. Antibody dependent enhancement will wipe out the democrat voter base and may be why they are pushing so hard for all of us to take the clotshot.
The very fact that they are pushing so hard makes me not want it. The ones that lied about everything so far, now I’m supposed to just “trust them” on not to try to kill me? No Thanks. Them pushing so hard makes my spider-senses tingle “danger!”
Also how they really put the hammer down on HCQ and ivermectin was super suspicious to me. Tells me they were fixated on the vaccines and not brokering any alternative paths. As they needed the EUA and any alternative effective therapeutics would derail the EUA. Why? Maybe simple reason might be plain old greed and that the vax is ok. Seems to be a convoluted way to make money but ok. but more nefarious reasons seem to be becoming more evident by the week as bears numbers climb up.
If you haven't been paying attention, [they] manipulated the numbers so as to make it appear that the "common cold" and "flu" weny away with COVID left standing. Why else would [they] do this, but to force a "vaccine" onto us?
Oh, I have been paying attention. All I am saying is the next corona virus is going to wipe out a shit ton of people(common cold is a corona virus). Dr Sheri Tenpenny talks about these MRNA vaccines causing ADE and how it creates a cytokine storm that will cause multi system organ failure.
It won't kill everyone.
There's likely a large control group who received benign injections.
The enemy's plan is likely to implement a mandatory annual or semi-annual booster shot that kills a small percentage of the population each year. They can sneak it on to us that way. They could also selectively cull any particular sheep by controlling whether they got the kill-shot or the placebo.
Lots of ways they could be playing this but an intentional mass die off would be very stupid of them.
You have to first be considered sane in order to be declared "out if your mind." These "people" and agencies were NEVER of the right mind. Everything we see now is a culmination if millennia if planning and prep work for what's coming.
NCSWIC goes both ways, after all.
They deadline was pushed back to early 2022 which means there is enough time for more horror stories with the vaxx to come out.
But Pfizer is getting expedited or preferred(?) review this September. It could be earlier than Jan 2022.
They delayed it till January 2022.
It was supposed to be this September.
From July 21st
Sounds like who ever wrote this article is in bed with Big Pharma. Tells you what we're up against.
When might the vaccines be approved?
On 16 July, FDA accepted Pfizer’s application “under priority review”—meaning it will move faster than during standard reviews, which typically take at least 10 months; the agency now has until January 2022 to review the materials. That seems like a long time, but last week an FDA official told CNN that the decision is likely to come within 2 months. “The review … has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the [January] Date,” an FDA press officer confirmed to Science in a statement.
FDA has not formally accepted Moderna’s application, possibly because the company has not yet submitted all the required materials.
Why have there been calls for faster approval?
Full approval could help overcome vaccine hesitancy, Eric Topol, director of the Scripps Research Translational Institute, wrote in a recent op-ed in The New York Times. “Some people who understand that the ‘E’ in ‘EUA’ stands for ‘emergency’ are waiting for full FDA approval before they receive a shot,” he wrote.
“I think it’s fair to say that any number of us who are clinical infectious disease doctors and in public health are frankly a little surprised at how long the process is taking,” says William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center.
“I want [FDA] to be careful. I also want them to move it along,” Schaffner says. “Frankly, I’d like them to work on the weekends. The people who are vaccinating are working on the weekends. The virus is working on the weekends.” Will approval really convince more people to get vaccinated?
About 30% of unvaccinated people say they were waiting for vaccines to receive full approval, according to a survey of 1888 adults conducted in June by the Kaiser Family Foundation. But the report cautions that for many people, FDA approval is likely “a proxy for general safety concerns.” Not everyone now focused on approval may actually get a vaccine, especially if they perceive the approval process as rushed or politically motivated.
“For the people who are really dead set against getting the vaccine at this point, I don’t know that the FDA giving it full approval is going to make a huge difference,” says Krutika Kuppalli, an infectious disease doctor at the Medical University of South Carolina who says many of her patients are wary of COVID-19 shots.
But full approval may sway some people. For example, for members of groups that have been treated poorly by the health care system, signing a consent form to get vaccinated—a requirement for vaccines with an EUA—may be a psychological barrier, Gandhi says: “Signing a consent that says ‘experimental’ and the phrase ‘experimental’ brings up issues of experimentation on Black and brown communities.” Will approval pave the way for mandatory vaccinations?
More than 500 U.S. universities and some high-profile hospitals have already issued vaccine mandates, meaning staff and students must be vaccinated.
But many schools and hospitals are hesitant to ask their employees to take what is technically still an experimental product and are holding out for full approval; so is the U.S. military. Some states, including those with some of the lowest vaccination rates in the country, such as Alabama, Arkansas, and Tennessee, have gone so far as to ban mandates in schools and colleges until vaccines are fully approved. (Conversely, a judge this week upheld Indiana University’s vaccine mandate after it was challenged by a group of eight students.) Once a vaccine is approved, “I think it will be on firmer foundation for organizations and businesses to mandate it,” Goodman says.
In France—where vaccine hesitancy is also running high—more than 1 million people signed up for a vaccine after President Emmanuel Macron announced on 12 July that vaccination would become mandatory for health care workers and “health passes” would be required to enter malls, bars, restaurants, and other public places. But those measures proved controversial as well: Tens of thousands took to French streets on Saturday in protest. Could FDA speed up its approval process?
Perhaps, but the agency does not want to rush. “Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy,” FDA’s Peter Marks wrote in The New York Times in response to Topol’s plea for speed.
“Any claims that this is taking a long time [are] almost like saying you don’t want FDA to do the normal, complete job that it does,” Goodman says. Regulatory rigor is especially important for messenger RNA vaccines, which use an entirely new technology, he adds. Is it safe to get a vaccine that only has an emergency approval, not full approval?
Every expert Science talked to had the same message: The data amassed so far show the vaccines given an EUA in the United States are very safe and very effective. “It was really incredible to see how well these vaccines worked in the clinical trials,” Gandhi says.
“The vaccines are such a gift,” says Cody Meissner, a pediatrician at Tufts Children’s Hospital specializing in infectious diseases and a member of FDA’s vaccine advisory committee. “Every adult should get this vaccine.”
Yes definitely starting to see more articles like this presupposing it will be approved (rubber stamped).
Ironic because in German “Gift” means poison.
Exactly what I deduced from the article, that the deck in stacked to produce exactly the results they want to achieve. Notice the guy that's on the advisory board said, "Everyone need to be vaxed."
I tell people I’m waiting for FDA approval, but only as a stalling tactic.
It’s a no from me, dog.
To me the basic question remains: Why would I get a vaccine that is either no good now, or will be ineffective soon after given, when there is a drug I can take to make the virus worse severe than a common cold.
Exactly! And, for this very reason, the jabs should never be approved.
Not to mention, if you get the coof and survive, which 99+% of the population will, your immune response will be much more effective than the jabs.
My health system is banking on September approval. The official line is that the jab is optional until approval. But plans are being made to add per diem staff after Labor Day.
If the DOD is preparing to make COVID shots mandatory by 9/1/2021, then it's a fair bet to say that these shots will be fully approved by then.