Many people are unaware (we fear) that the SARS-CoV2 products are still in clinical trial studies and not fully FDA approved. Did you know that?
Both Pfizer & Moderna are becoming increasingly accessible for all humans 16 + years of age and higher. To some - they think this is good news. I personally am troubled by it and I am entitled to my perspective just like you. These injections are mostly available for mass market distribution and can be found at your local convenience stores. Convenience is wonderful for healthcare needs. However - we are most concerned with the fact that your average adult, when told that these drugs are not out of application process for full FDA approval, find themselves startled or unaware. They are clueless. In fact a member of our own family thought they were getting a flu vaccine!
It is apparent that there is a theme of a breech in Informed Consent for these patients somewhere down the line. We will not point the finger as to where. However it is important to share the following picture we compiled that is a shocker to some. This is because they did NOT know what they signed for when they "took the jab". They did not know that full FDA approval has NOT been granted yet. As we know - once you put these drugs in your body - there is no turning back from that decision!
According to the Clinical Trials Government website , readily available for purview (but very hard to find), these two injectable products specifically to right in photo are NOT out of their FDA approval timeframe. Yet millions of people stand in line and feel it is their duty to undergo being a specimen in a "trial" study. Why?
We are including the links here additionally so you can do the research on your own. You will be able to watch /follow the clinical news re: their application process for full FDA approval as time passes.
It is very important to note that both of these products above on this public database website do NOT have any official results posted under the "Results Posted" tab on these pages below..... We know a large database called the VAERS has patient initiated data but is very hard to circumnavigate for conclusion. We would like to know why though the Clinical Trials Government website in this section does not.....Wonder why?
Clinical Trials Website Link for Pfizer: Completion of Studies April 6 2023
Clinical Trials Website Link for Moderna: Completion of Studies: October 27, 2022
We are struggling to find the Johnson & Johnson Janssen data for end date of trials such as above. We think this is because the vaccine they offered was pulled from the market for a timeframe due to some severe side effects found in some patients. However on April 23, 2021 - a decision was made to allow J & J to resume injecting human beings with their product regardless of said data! We will upload an end date for their trials if we find it!
Let's not forget here; pursuant to earlier blog we did - that all of these SARS CO-V2 Virus products are still in what is called an EUA status for delivery. It's important to know what that means. You can read our post on that subject HERE.
However, in layman's terms, quickly to note: EUA means that these products have been initially approved for Emergency Use Authorization ONLY. This does NOT mean they have crossed the finish line yet! That's very important to consider.....
All drugs in order to garner full authorization and labeling through the U.S. Federal Drug Administration (FDA) - all manufacturers need to complete a Biologics License Applications (BLA) Process (CBER) after they have completed all phases of clinical trials. As shown in arrow below in yellow - It is "supposed to be" a stringent lengthy process. When you go to the link here in this section above - note we adults, as a human species, at present are still in the clinical studies phase on that list.
Pfizer in fact is now trying to submit an early BLA authorization with only six months of longitudinal data on humans after taking the vaccine at their disposal. We are worried that the long-range study for this group is not long enough. As you will see below from Johns Hopkins very own website - that other typical vaccines take a plethora of years to finalize. Not to mention it is so very important to do these studies with enough candidates willing to be studied in order to get a firm assessment. Read the article from Pfizer Investors directly here.
Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.
Our youngest children are just now beginning PHASE 3 portion of this arrow below for those who seek this product for their kids. Please know adolescent studies for these products are very limited on how many children are actually studied before these products are made available to you still in an EUA format.
Based on an article written today in fact, May 11 2011, by Harvard Health - It would appear they only have a small % of children being studied in comparison to a world of children who may be injected. Keep that in mind. Read this for the Pfizer trial:
The EUA's extended authorization was based on results from a Phase 3 trial testing its vaccine in children ages 12 to 15. The trial enrolled 2,260 adolescents; half received the Pfizer mRNA vaccine, the other received a saltwater placebo.
Also on this same Harvard site in that article they go on to reveal the following for Moderna. Testing in children appears to be an even lesser % of those being studied:
The age de-escalation studies are smaller than the adult trials; rather than recruiting tens of thousands of participants, they will recruit 2,000 to 3,000 participants within each age group. As in the adult trials, some children in each trial will get a placebo.
We will be remiss if we did not remind that health data indicates that children are less likely to have severe symptoms or any symptoms at all with COVID. So why are we putting unknown injections into their bodies?? Read an article posted from Mayo Clinics: COVID-19 (coronavirus) in babies and children to see how they say children are less likely to become sick.
Vaccines specifically have always had a very stringent process over many years process to get to the final approval - UNTIL NOW. That's important!
Never in history have we jumped through this many pharmaceutical hurdles, and perhaps sidestepped some others, to achieve (minimalistic in our opinion) sufficient enough data points. In fact on the Johns Hopkins website it firmly states the following about getting a vaccine into fruition. This has been the way its been for decades previous to now:
"A typical vaccine development timeline takes 5 to 10 years, and sometimes longer, to assess whether the vaccine is safe and efficacious in clinical trials, complete the regulatory approval processes, and manufacture sufficient quantity of vaccine doses for widespread distribution."
I learned a lot about all the steps of becoming a vaccine at these websites above. I suggest you do the same. Just the same as I did way back when as a youth and we watched School House Rock on another topic for History. Which at the time for school was all the necessary steps for "Bill" to become a Bill through Congress in America. Trip down memory lane for extent of how long it took to do something very important is why this is being shared!
Think about the comparison of Vaccinating an entire human race versus a legislative document called a House Bill when you watch that video here. As "Bill" the paper product was kicked back, and he was pushed around a lot, before he became a law. In some cases these legislative bills take YEARS of back and forth in Congress before they become law.
Why then do SARS-CoV2 products entail especially where health (YOUR health) is concerned be so short in length of time to sign on the dotted line? It makes no sense to me especially given this virus has a near 99% recovery rate with preventative treatments early enough.
Any medicinal process that only takes months in the grand scheme of things and has never been done before should really be scrutinized fully for your family. Especially if it becomes a mandatory requirement. Watch Bill below and think of him as your vaccine.
We are not doctors over here at the Busy V Hive. Very far from it. However we are parents. We strongly encourage all people considering to receive the SARS-CoV2 vaccine products to do the research especially for your children.
Read about what is called Informed Consent when considering EUA products in general. This is a very important clause to bear in mind. Found at Health Affairs under their blogs:
Interpreting The EUA Statute
"The EUA provision was added to the federal Food, Drug, and Cosmetic Act (FDCA) in 2004 to give the government increased flexibility to respond to a chemical, biologic, nuclear, or radiation threat. When the pathway was created, special language was included for informational disclosures for individuals offered a medical product under an EUA. Specifically, under 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III), each individual must be informed “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”
This above means, that when you go to take the shot, you need to be provided (among other things to be given) a Fact sheet on the medicine they are injecting into your body. Ask to see the box it came in - Ask to see the pamphlet insert that usually comes along with all pharmaceutical products. Most importantly - You need to know that YOU are part of a clinical trial study prior to a full approval by the FDA at this time whereas all of the SARS-CoV2 vaccines are concerned!
Click on this blue box below here. The CDC website you need to go to will open up for the EUA fact sheets on these products. You can find this section in blue that looks like this picture below. Scroll down on this page to this section. Please do me a favor and download each of these sheets below. Study them thoroughly & bring to the doctor prior to receiving your shot.
Ask a tremendous amount of questions with your primary care physician regarding efficacy of any one of these shots versus fighting the SARS-CoV2 virus on your own without having to take a jab. Especially since they are all still in clinical trial studies.
The latest data for beating the virus without having to take an experimental/investigational shot indicates you stand better than a 99% chance of full recovery. We found a great resource to learn about ways to increase your immunity and maybe fight the COVID virus as a whole. HERE
In the end - you may think you are doing a noble thing for others by taking a COVID vaccine and perhaps saving a life. BUT let the truth be told .... you must know by doing so - you are no different than these cute mice right now and may be putting your own life on the line.
You need to know that it is your right to willingly accept or refuse the process according to federal and state laws and you are not to be considered as a test human subject. Unwillingly/unknowingly used for experimentation, as was the case during WW2 timeframe, was a high crime of humanity. Please read about the Nuremberg Code of 1947: HERE
In the end....Who is the best advocate for you and your family....YOU! No Doctor or government official has the authority (or right) to take these health care decisions/actions away from you especially with regard to your children.
Sadly - it has come to light today that in Michigan, a health clinic and doctor thereof, are taking the role as a medical physician with the "take the jab" to a whole new level of authority. One must question if there are more like him across the world - we shutter to think.
He believes it is his sovereign right/authority to subject children to SARS-CoV2 injections WITHOUT parental consent when they come into his office for well care visit and normal vaccinations. He gives them micro-doses of the COVID injections w/o approval by parent!!! A whistleblower is forthcoming in days ahead on this topic. But please...please...please....At least watch this video below to learn what is happening to children in Michigan and maybe happening to them all across our country without your knowing/approval.
This Queen V Mom is outraged to have to share this video below. No one shall touch my children without full consent of my authority. You must watch just after 6:00 minutes forward at least to understand the gravity of what we could be facing. Please consider sharing this blog post out to everyone you know. I did my best to bring a pertinent matter to the forefront for your consideration. Thank you!
Stew Peters/Red Voice Media - Kids 'Vaccines' WITHOUT Consent
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