Posted on 12/27/2020 7:36:05 PM PST by blam
Major Covid Vaccine Glitch Emerges: Most Europeans, Including Hospital Staff, Refuse To Take It
All is not going according to plan in the biggest global rollout of what is arguably the most important vaccine in a century, and it is not just growing US mistrust in the covid injection effort that was rolled out in record time: an unexpected spike in allergic reactions to the Pfizer/BioNTech vaccine (and now, Moderna too) may prove catastrophic to widespread acceptance unless scientists can figure out what is causing it after the FDA’s rushed approval, and is also why as we reported yesterday, scientists are scrambling to identify the potential culprit causing the allergic reactions.
Making matters worse, Europe rolled out a huge COVID-19 vaccination drive on Sunday to try to rein in the coronavirus pandemic but even more Europeans than American are skeptical about the speed at which the vaccines have been tested and approved and reluctant to have the shot.
While the European Union has secured contracts drugmakers including Pfizer, Moderna and AstraZeneca, for a total of more than two billion doses and has set a goal for all adults to be inoculated next year, this is looking increasingly like a pipe dream: according to recent surveys, the local population has expressed “high levels of hesitancy” towards inoculation in countries from France to Poland, with many used to vaccines taking decades to develop, not just months.
“I don’t think there’s a vaccine in history that has been tested so quickly,” Ireneusz Sikorski, 41, said as he stepped out of a church in central Warsaw with his two children.
“I am not saying vaccination shouldn’t be taking place. But I am not going to test an unverified vaccine on my children, or on myself.”
(snip)
(Excerpt) Read more at nationandstate.com ...
Okay.
You are a member of the “health care system.”
A “health care system” is a bureaucracy.
The primary goal of any bureaucracy is to perpetuate itself and glom onto as many resources as possible.
Over time, all bureaucracies become metastatic cancers that demand so many resources that they overwhelm the host they are parasitizing.
By definition you are a professional affirmative-action self-perpetuating bureaucratic parasite.
I don’t really give an excrement what you think.
Skepticism is healthy and fine.
Making wild, insane, unfounded claims in order to convince people to alter their decisions is not. There is no “GMO” involved.
Weighing the risks and benefits is everyone’s right. When you fill their heads with false information in order to scare them, you’re robbing them of that right. It’s anti-freedom to spread baseless fearmongering. Stick to facts.
At least as far back as March? I apologize for not being clear... I think that is Moderna, I was talking about Pfizer—and I should have specified Phase 3—sorry I did not specify...Phase 1 and 2 seem to be very small-sized trials, and according to someone I know who does Biostats on clinical trials, Phase 1 is healthy adults—not ill...no co-morbidities.
Not sure the Phase 1/2 trial size on Pfizer, but Phase 1 it was started April 29. #1c
And it seems they combined Phase 1 and 2.
NEW YORK & MAINZ, Germany—(BUSINESS WIRE)— Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week. #1a
Jul 1, 2020 — ...from the ongoing Phase 1/2 clinical trial of four vaccine candidates will enable ... global Phase 2b/3 safety and efficacy study that may begin as early as ... Pfizer would work jointly to distribute the potential COVID-19 vaccine ...#1b
Phase 3 began last week July, first week August:
Pfizer and German biotech partner BioNTech have on the same day as rival Moderna kick-started a late-stage effort for their “best” attempt at an mRNA pandemic vaccine.
Moderna announced early Monday that, alongside a near half-billion extra in Biomedical Advanced Research and Development Authority dollars, it has started a boosted 30,000-patient phase 3 for its vaccine; not to be left out, Pfizer and BioNTech announced after-hours that they too were starting a late-stage attempt. #2
Thanks for the replies...I am trying to learn enough to have your level of trust to be an early market adaptor for experimental drug/new therapy...
At this point, I am still researching to find info to support my comfort zone...and I am taking the Zelenko protocol.
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#1c https://www.clinicaltrials.gov/ct2/show/NCT04368728
So what you’re saying is that you don’t really have a coherent, fact-based reason to fear these Trump vaccines. Rather, what you have is an irrational hatred of doctors, nurses, and pretty much every aspect of society including all religious organizations?
It isn’t “experimental”; it’s a drug which has been approved through the normal process following clinical human trials lasting for several months and involving tens of thousands of closely monitored volunteers.
Nothing was rushed and President Trump isn’t trying to kill you, despite what the Democrats have claimed.
Oh that may be the difference...tho I read 1955. I had a sugar cube—not a shot...
Polio vaccine has been available since 1955. The inactivated polio vaccine (IPV) was available first, given as a shot, in 1955. A more convenient form, called oral polio vaccine (OPV), was given as liquid drops via the mouth. It was developed in 1961.* May 11, 2020
ok
Risk factors for severe COVID-19 complications include obesity, cancer, diabetes, being over 65 years old, heart conditions, lung conditions, and kidney conditions.
42% of the US is obese. 5% have cancer or are cancer survivors. 10% have diabetes. 15% are over 65. Nearly half of American adults have cardiovascular disease. 11% have chronic lung disease. 11% have chronic kidney disease.
While there's overlap on much of these, some estimates put ~60% of the total US population as having risk factors for severe COVID-19 complications. 23% of the population are children. So we've got about 17% of the country who can actually work without high risk right now.
Not an argument in favor of shutdowns (I'm against shutdowns, mandates, etc.), but this "healthy people" concept is largely a myth. We are NOT a healthy nation. We're a nation primarily made up of sick and dying people who have failed to take care of themselves and are now paying the price.
The Chinese flu has a 99.98% survival rate for people without comorbidities.
There is no need for a “vaccine” forced on the general population, but that’s what you are going to do because that’s where the money is.
There should NEVER have been a lockdown, but thanks to self-serving, self-satisfied bureaucrats like you America is ending.
You aren’t going to like what comes next, but unlike a lot of us, you are going to deserve it.
So if we took care of ourselves we would live forever?
Nobody is forcing a vaccine on the general population. This is paranoid fantasy.
"but that’s what you are going to do"
Strawman argument pulled from fantasy. I'm neither capable nor willing to force anyone to take a vaccine. I'm against mandatory vaccination.
"thanks to self-serving, self-satisfied bureaucrats like you America is ending."
I'm not a bureaucrat and I'm not "ending America". Nor is anyone else. The country will be just fine. But if you're convinced the country is ending, you should investigate other options.
We would live longer, healthier, happier lives. And we would have far less reason to be concerned about a virus such as this. I don't think I've ever met anyone who was against living a healthy life. Interesting.
It isn’t “experimental”; it’s a drug which has been approved through the normal process following clinical human trials lasting for several months and involving tens of thousands of closely monitored volunteers.
Nothing was rushed and President Trump isn’t trying to kill you, despite what the Democrats have claimed.
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Ah perhaps I am wrong, but I seem to remember your previous post from a few days ago...Something about Freepers should not be able to question the vaccines...And look here you are.
And I don’t recall you indicating that you are an expert on clinical trials, vaccines,a scientist or MD working in ER or COVID ward. Therefore, I am going to take the word of the Frontline Doctors who state that these vaccines are experimental...
Normal Approval process? It is not normal approval process and new therapies—The vaccine received an “FDA EMERGENCY USE AUTHORIZATION”—it was fast tracked with no animal trials..
“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research.#1
Several months? Not rushed? Seriously?!?! What is an Emergency Use Authorization and only a 2 months for Phase 3?
Frontline doctors say...Since it was fast tracked, it is experimental.
Now for the hyperbole about Trump...Listen FRiend...I was supporting Trump when FR was Cruz Country...(long before you were here). I still support our President, have been to rallies, etc... I KNOW President Trump is not trying to kill me...And I never said he was. Sheesh! Don’t put words in my mouth...and it is not a Democrat/Republican issue.
That said, just because I support the President does not mean that I trust Drs. Slaoui and Fauci, or Pfizer; nor does it mean it is wrong to do research and ask questions.
As I believe I told you before, this is, after all, FREE Republic where differing points of view and facts are encouraged.
Why are you so concerned about how other people are living?
Too much time on your hands?
I've made no such post saying people can't ask questions. If you want to claim otherwise, post the link.
"I don’t recall you indicating that you are an expert on clinical trials, vaccines,a scientist or MD working in ER or COVID ward. Therefore, I am going to take the word of the Frontline Doctors who state that these vaccines are experimental."
You're going to take the word of Mom MD and gas_dr? Thank goodness. Finally we'll all be on the same page.
"It is not normal approval process and new therapies—The vaccine received an “FDA EMERGENCY USE AUTHORIZATION”"
EUA has an approval process which has been longstanding, documented, and followed to the letter here. There are different processes depending on the thing being reviewed and the urgency as determined by the Feds; not the drug makers. In this case, it was President Trump who made the call to authorize the Fast Track approval process. But that's a normal, documented process. There was nothing abnormal.
"with no animal trials."
False information. Pfizer and Moderna did not skip animal trials.
"What is an Emergency Use Authorization and only a 2 months for Phase 3?
It's a longstanding, documented process used when there's an urgent need for a new drug or therapy. President Donald J Trump determined that to be the case here and authorized that these vaccines be placed into the Fast Track process. Again, it's a normal process. This wasn't just invented for COVID-19. It's existed long before COVID-19. It'll exist long after COVID-19.
The accusation that the trials and approvals were rushed and that the vaccines are untested and dangerous are part of a Democrat narrative designed to discredit President Trump and tarnish his accomplishments. If you choose to continue parroting the Democrat narrative that President Trump has recklessly endangered all our lives with rushed vaccines, then you go right ahead. But I know which side I'm on.
"it is not a Democrat/Republican issue."
It shouldn't be, but Democrats have made it that. President Trump drove this program to get safe and effective vaccines into our hands quickly. He succeeded. Democrats chose to make the vaccines political in order to discredit the president. President Trump says the vaccines are safe and effective. Nancy Pelosi and Governor Cuomo say they're rushed and dangerous. VP Pence has taken the vaccine and says it's safe and effective. Louis Farrakhan says it's poison. Frontline healthcare workers including doctors like Mom MD and gas_dr have taken the vaccine and are thankful for it.
I see President Trump, VP Pence, the rest of the White House, the FDA, the CDC, and doctors on FR lining up on the side of the vaccines being properly tested, safe, and effective. I see Nancy Pelosi, Louis Farrakhan, Andrew Cuomo, Gavin Newsom, and the leader of Hezbollah making wild claims about the vaccines being untested and unsafe. So yeah, it's a pretty political thing. I'm going to defend the president's hard work. I'm going to defend his accomplishments. While we eventually would have gotten vaccines either way, it would have taken months or years longer to actually get them into the hands of those who need them without the smart moves our president made early on.
"does not mean that I trust Drs. Slaoui and Fauci, or Pfizer; nor does it mean it is wrong to do research and ask questions."
Doing research and asking questions is great. Everyone should do a lot more of that, particular in an age where the media does a shoddy job - on a good day - at reporting factual information. But there is a chasm of difference between asking legitimate questions and parroting uninformed Democrat talking points that were created specifically to damage President Trump and tarnish his accomplishments.
You staked out a position that all the healthy people should be going about their normal lives. I pointed out that we don’t actually have very many healthy people. I don’t care if people choose to live healthy lives or not; just putting some context in place so this narrative that suggests there’s a tiny group of sick people who need to be held aside is exposed. The reality is we’d have about 17% of the US population still about to work. My guess is that’s about what’s left now in most states anyway, particularly since many are ignoring the new lockdowns/shutdowns anyway.
Again, I’m against lockdowns/shutdowns, mandates, and so on. But there is no giant sea of healthy people yearning to break free here. There’s a giant sea of sick people and it’s a shame we don’t have smarter people in elected office who could do a better job of creating policies that actually did something useful to save lives. Or at the very least, it would be nice if they could stop forcing nursing homes to accept infected patients.
Thank you for the animal research link...I found where I got the idea that they did not do animal trials...They started human trials without doing animal trials first...Isn’t it great that fake-news AP is now working to support the President on the vaccine rollout? Who knew!
But STATnews reported this in March:
So they did Phase 1 and Phase 2 concurrently instead of sequentially...
So I stand by what the American Frontline Doctors said in a press conference...The EAU makes the drug “experimental” so that is not as you say “normal”...Let’s not forget that it is also a novel therapy.
And an Emergency Use authorization is DEFINITELY different than normal clinical trial timeline...this was shorter...I have a family member (PhD) who actually works with Pharma clinical trials who confirmed this...
You really have a problem with putting words in my mouth...I never made accusations, never used word “rushed.”
It is not an accusation to say trials were “fast-tracked”... It is a fact that they were...Phase 1 and Phase 2 concurrent, and approx. 2-2.5 months for Phase 3.
I did not make an accusation that they were unsafe or untested...Phase 1 and Phase 2 were concurrent...That is not normal...Again, I did not say it is unsafe. I am trying to determine how safe it is to assess risk in taking it... safe...And what is wrong with that? How do I do that? Ask questions, look at different sources, etc.
If you wish to imply that my asking questions, having concerns, and having some skepticism is somehow a lack of support for President Trump or VP Pence and “tarnishing” his achievements, you are barking up the wrong tree, FRiend. As I said, I have been a long-time Trump supporter as many here will attest...I understand the need for the vaccine ASAP, and I certainly commend our President for marshalling the resources to bring it, but that does not mean I can’t have concerns and ask questions.
Frankly, I don’t trust some of the leadership in our health
bureaucracies. They have not always supported the President’s initiatives, nor have they all been honest with the American public. Additionally, there have been pharma drug rollouts that have resulted in unintended side-effects. Ex. H1N1 ...Rise in children developing narcolepsy resulting from 2009 Pandemrix Influenza Vaccination in Europe—Dr. Slaoui and Fauci(?) https://www.cdc.gov/vaccinesafety/concerns/history/narcolepsy-flu.html
As far as being on same page with other Freepers, since when do we all need to be on same page?? This is not Democrat Underground...it is FREE Republic. We can have differing opinions and positions. Though I certainly appreciate and value all the Freeper medical personnel input, I don’t know their experience, field of expertise, etc...I have read CVs of America’s Frontline Doctors and seen them testify before congress. So I am eclectic and looking at what all open-minded reasonable Freepers have to say as well as other sources...
My asking questions or having some reluctance in no way prevents you from being first in your category to get the vaccine. You and yours, and Gas-Doc, Mom MD and anyone else are all welcome to take the vaccine ASAP...Actually, I think it is great because you all can report back to the rest of us who don’t qualify yet about your experiences and impressions.
My questions and comments are not “Democratic talking points” simply because you don’t like them. And actually America’s Frontline doctors have been supporting treatment regimens recommended by the President.
You may not have made the original post about which I wondered, but you certainly seem to want to go after me for asking some honest questions.
Clearly an oversight on their part. No doubt somebody got fired for accidentally posting truthful information.
"So they did Phase 1 and Phase 2 concurrently instead of sequentially..."
That's somewhat misleading. What they got approval to do was to start the Phase 2 clinical trials before full data was available from the Phase 1 trials. The purpose of the Phase 1 clinical trials is entirely safety: "does this thing you want to put into people cause severe problems?" You test this by giving to a very small group (e.g. 100 volunteers) and making sure it isn't killing anyone or causing major problems with any of them. Typically you would wait until all the data has been compiled and submitted to the FDA, let it sit in some bureaucrat's inbox for a few months (or longer) while he finishes up naptime, then you get approval to begin Phase 2. What many of the manufacturers were allowed to do in this case was to begin Phase 2 without waiting on approval. In practice, you give the drug to 100 people, observe them for a period of time in which any serious side effects should present themselves (e.g. if your drug breaks down in hours or a few days, a week or two is likely plenty of time to see if any of the components will cause major problems), then you just move right in to Phase 2.
Admittedly, this is less common. But it's not unheard of when something is in the fast track process. That process is designed to clear a lot of the inefficiencies that exist in the longer, extended process where non-urgent things go.
"an Emergency Use authorization is DEFINITELY different than normal clinical trial timeline...this was shorter."
My point was that there are multiple tracks/processes for drug approvals. There is nothing unusual or special about the process used for testing these vaccines. It's the same process for anything on the FDA fast track program. This process is the same for anything which is authorized for the fast track process. From the FDA site describing the program:
"Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients."
This is a normal thing. It happens for plenty of other drugs in development where there's an urgent need. If you're testing a new diabetes drug and there's 75 other options already available, you don't need to move quickly. If you're testing something that's going to prevent many fatalities, you (we, the American people) can't afford to wait for several years while overpaid, underworked FDA bureaucrats hit the snooze button at their desk.
You have to look at how economic coercion is going to wielded. If it was never the intent to use economic coercion, the employer protections by the federal government and EEOC would not have been needed. If that fails, next will be what CNN described as Vaccine Passports. First they vaccinate those who volunteer, then the coercion begins.
It is easy to see what was intended by looking at who other then the drug manufacturers have been given protection by the Federal Government over the administration of the vaccine. I am not an anti-vaccination type at all, but I will take a wait and see approach.
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