Posted on 05/04/2021 7:26:31 AM PDT by SeekAndFind
The Chronicle of Higher Education published an astonishing list of 195 colleges and universities, both public and private, that will require all students to receive the COVID-19 vaccination to attend classes on campus in the fall. It would be astonishing if no students challenged this requirement based on the status of the vaccine alone. According to the FDA, the vaccines for COVID-19 are still considered investigational:
This guidance describes FDA’s current recommendations regarding the data and information needed to support the issuance of an Emergency Use Authorization (EUA) under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19, including chemistry, manufacturing, and controls information (CMC); nonclinical data and information; and clinical data and information, as well as administrative and regulatory information.
The FDA defines an investigational drug as experimental:
An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:
- If the drug is safe and effective.
- How the drug might be used in that disease.
- How much of the drug is needed.
- Information about the potential benefits and risks of taking the drug.
No one should be forced to be part of a clinical trial. This decision should be made between a patient and a healthcare provider based on many factors, including the risk of severe disease, the likely efficacy of current treatments, and other criteria. It might even include a second opinion. These universities ignore both fundamental features of our medical system and the right to informed consent and a second opinion. These are especially important for an investigational drug.
(Excerpt) Read more at pjmedia.com ...
Students who do not want to get vaccinated should request an ADA reasonable accommodation. The amount of paperwork, legal involvement, etc will make the cost of this policy beyond what most colleges are willing to carry. Oh and the school cant simply say, no you are not a student any more. That would be an automatic discrimination case and potential ADA lawsuit.
Furthermore, schools who disarm law abiding citizens should also be held similarly liable for the safety of all those on campus.
It’s almost comical that they’ll make myriad accommodations for food allergies or service animals, but this?!? No way!!
Read Denninger’s take on these shots:
http://market-ticker.org/akcs-www?post=242268
‘High school senior Emma Burkey received her “one and done” Johnson & Johnson coronavirus vaccine on March 20, and within two weeks was in an induced coma following seizures and clotting in her brain.”
She’s making a slow recovery, having recently been transfered from the hospital to a rehabilitation center, and the first round of bills totaled $513,000. The 18-year-old’s family friends in the Las Vegas area started a GoFundMe account to help with medical expenses from the very rare vaccine reaction.
“
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“Maybe health insurance will pay Emma’s bill, at least in part. What’s Emma’s deductible, if she has insurance? Will she be eating that deductible every year for the rest of her life with a continuing care requirement? Will her insurer refuse to pay entirely, since these were experimental shots? What happens if Emma wants to start a family and tries to get life insurance down the road? Will it be available at any reasonable price? Has her ability to bear a child been damaged or destroyed? What about her ability to enjoy all the things she used to enjoy; will she, for example, still be able to go for a nice jog? Can she hold a driver license? What about a CDL or pilot’s license? What about something as simple as driving a forklift in a warehouse? Have the seizures permanently destroyed those options for Emma?
Emma’s medical chart has been permanently branded by this incident and there is no possible way to erase that branding which is now in the MIB and will be with her forever. It will impact her ability to get a job and it will do lifelong damage to her economically, even if medically it appears she fully recovers, which of course nobody knows at this time.”
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NOBODY in my family will be getting the bogus “vaccines”.
The risk is too high.
Nazi doctor Karl Brandt was hung in the Nuremberg gallows for allowing medical experiments to be conducted on humans without Informed Consent.
History has a way of repeating itself sometimes.
Thanks seviex for the post. same here.
The FDA.
Something I have noticed about all the reports of bad reactions is that it seems to affect females more than males.
Rashes, clots, strokes, spontaneous miscarriages.
It’s almost as if this a means to reduce our population of newborns by making women infertile.
A private business should be able to require whatever it wishes. To support that idea is to be a conservative.
If you don’t like a businesses rules, you are free to go to a competitor. That’s called the free market.
Mask mandates are only wrong when GOVERNMENT requires them.
Oh yeah, I forgot about the breast feeding babies who have died.
The government is pushing for employers to mandate the shot. Thankfully my employer doesn’t trust the shot. If he did require it, I have no problem giving my 2 week notice, but that puts them in a sticky situation. They are desperate for workers.
https://media.tghn.org/medialibrary/2020/11/C4591001_Clinical_Protocol_Nov2020_Pfizer_BioNTech.pdf
Hosted on The Global Health Network; https://tghn.org/
Page 42
Study Population > Exclusion Criteria
Women who are pregnant or breastfeeding
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Meanwhile we've heard of pregnancy losses and pregnant women were excluded from trials yet they are going jabbing pregnant women.
Page 27
2.3 Benefit/Risk assessment
"There is an ongoing global pandemic of COVID-19 with no preventative or therapeutic options available."
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LIE
Page 44
Lifestyle considerations
(make sure all women are taking a contraception)
Page 68
Spontaneous abortion including miscarriage and missed abortion
Page 88
24-Month Follow-up Visit: (714 to 742 Days After Visit 4)
~~~~~~~~~~
Guess they're doing that sometime next year?
Page 136
Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations intransaminases) are termed “tolerators,” while those who show transient liver injury, but adapt are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a more serious potential outcome. These participants fail to adapt and therefore are "susceptible" to progressive and serious liver injury, commonly referred to as DILI. Participants who experience a transaminase elevation above 3×ULN should be monitored more frequently to determine if they are an “adaptor” or are “susceptible.”
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Page 67 takes the cake though. Is that why they're pushing everyone to get the jab? Will be interesting to see the birth rates over the next year or three and also pregnancy issues like spontaneous abortion, still births etc.
"exposed to the study intervention by inhalation or skin contact"
So when full approvals are issued this summer or early fall, this objection will no longer be there, correct?
Pfizer and Moderna are expected to file for full FDA approval in the next few weeks. They have all the required trial data to do so already.
It's been posted on this blog multiple times that the FDA authorizes COVID19 vaccines under an Emergency Use Authorization. As you have ignored time and time again, the COVID vaccines are authorized by the FDA, not 'approved'.
The current vaccines necessary for schools are 'approved' by the FDA.
The law against forcing people to take an experimental medicine will not be in play once the shots are fully approved, but I am curious how the manufacturers managed to collect long-term safety information in less than a year. It was my understanding that the minimum duration of such trials was 2-3 years.
The objection will remain for many people - the law will no longer protect them.
The first clinical trials began March 16, 2020, so that’s over a year. It’s not 2-3 years, but it’ll be about 18 months after trials began when FDA approvals come for the first two.
For many schools the headline reads - require
These schools in the details say - intend to require
Drexel is one excellent example of this scare tactic.
Please post evidence of your fast timeline for full fda approval.
Mers vaccines were never approved, Due to ADE, antibody dependent enhancement. The vaccines made the coronavirus infection more deadly.
In sars-cov2, the spike protein itself may prove to be a disease agent, on top of potential ADE.
Who says full approval is just days away?
TIA
Colleges requiring “vaccine” seems so anti-American.
MERS infected a grand total of 2,574 people in the entire world. That’s 0.00003%. Few trials were conducted because there’s no market for a vaccine to a disease nobody has. However, development work that began for SARS2003 and MERS2012 vaccines provided a lot of lessons, like how the nucleocapsid proteins are a poor target due to ADE risk and low neutralization rates and how the S protein was the safest and most effective target. That made it real easy to see where to start when SARS-CoV-2 arrived.
S proteins in the lungs have been shown to potentially (and this is all very preliminary) cause some issues in lung tissue. Which is all the more reason to avoid a COVID-19 infection since that tends to produce a huge number of S proteins running wild throughout the body. A vaccine produces a small number of S proteins in your arm and dendritic cells transport a small number of them to your lymph nodes for T cell production.
No signs of ADE have been found in any vaccine recipients and people have now been vaccinated for well over a year. No sign of lung damage either. With over 140 million Americans now vaccinated, there is ample evidence the vaccines are both safe and effective. FDA pulls an EUA at the first sign of any possible issue (just as they did with J&J). There have been no signs of issues with the Pfizer or Moderna shots aside from the known anaphylactic reactions which occur at a low and predictable rate. FDA has signaled no hesitancy to approve them, but they HAVE signaled that they will provide expedited review (meaning a response expected within 6 months of filing).
Full approval is not “just days away”. That’s not the timeline I gave. Filing for full approval will happen in May, likely for both Moderna and Pfizer, but almost certainly for Pfizer. FDA approvals will likely come by August or September. It’s possible they could do it by July, but that would surprise me, especially with Biden in office. President Trump would gladly light a fire under them to keep them moving, but Biden will sit back while some FDA bureaucrat lets the paperwork sit in his inbox while he sleeps off the sauce he’s been hitting all morning at his desk.
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