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According to John Hopkins University (coronavirus.jhu.edu/vaccines/timeline), a typical vaccine development timeline takes five to ten years, and sometimes longer, to assess whether the vaccine is safe and efficacious in clinical trials, complete the regulatory approval processes and manufacture a sufficient quantity of vaccine doses for widespread distribution.
Those of us who have been actively following the bioweapon agenda over the last two years will not be surprised to see the latest development: our compromised FDA has approved the Pfizer vaccine. We all know that severe mandates will be following as is evident in many states where medical institutions are requiring that all their employees get the lethal jab.
Everything seems rushed and haphazard with no sense of order. Perhaps we should take this as a sign of an opponent trying to “appear” strong when, in fact, they are weak and panicked. Prayers, meditation, connection with Source, calm and deliberate action based on much forethought are the things most needed right now. Please remember that our unawake brothers and sisters will be needing our help the most over the next 6 to 8 months. Be kind and compassionate. As disclosure rolls out, we must be the very foundation of love and wisdom to help move humanity through the pinnacle of this spiritual battle.
- For Immediate Release:
- August 23, 2021
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.
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Disclaimer: We at Prepare for Change (PFC) bring you information that is not offered by the mainstream news, and therefore may seem controversial. The opinions, views, statements, and/or information we present are not necessarily promoted, endorsed, espoused, or agreed to by Prepare for Change, its leadership Council, members, those who work with PFC, or those who read its content. However, they are hopefully provocative. Please use discernment! Use logical thinking, your own intuition and your own connection with Source, Spirit and Natural Laws to help you determine what is true and what is not. By sharing information and seeding dialogue, it is our goal to raise consciousness and awareness of higher truths to free us from enslavement of the matrix in this material realm.
Who in 2021 trust the FDA, I don't, what ever they say it's good, it's bad , see who is behind, follow the money
Opening the door for class action injury law suits. Opening the door for RICO prosecutions for Conspiracy and Racketeering. This is not the first time the CDC has been charged with RICO if you remember the drug Levaquin and the envelope handshake fast track approval. They have been doing this for decades and it is time to jail all of these bad actors.
The Doctors executed at Nuremberg did far less damage and paid the ultimate price for their actions.
Im 54, I don't use any RX drugs , or over the counter drugs and I will never take any vaccine.
I dont trust big pharma or this government about anything, period.
Im detoxing my body constantly and I quit all alcohol consumption, which wasn't much to begin with.
I left a populated area over two years ago and moved to an AG area and built up my own homestead too, even bought a 7×9 feet greenhouse.
I have done nothing but store food all summer.
I have freezers full of meat and guns full of ammo.
Get ready everyone, our lives are at stake here more than ever in my lifetime and I survived 8 years of Obama with all of his pandemics and none were like this if you recall.
Be strong and get you kids out of public schools!!!!!
Congratulations, Azurite Crystal, with creating your own living conditions, in a less dense populated location, although I'm not familiar with the term "AG area". If I was born in a part of planet Earth, with vast stretches of wilderness, free to live and create those conditions, I would've done this earlier. I'm a born Dutchy, and the alternative of living in the wilderness, creating a homestead, greenhouse, a self reliant existence as much as possible, but not isolated as a hermit, is my jump overseas, to Britain.
For almost 5 years I've lived in rural areas in the S. West of Britain, pleased with the silence of the moors, and the beauty of the Atlantic Ocean's coastline on that island, 6 x the size of the Netherlands. I've returned to my home knowing that living conditions are better in my country of birth. Britain shows up merely in dramatic extremes, either negative or positive, which keeps society in a continuing see-saw of uncertainty, short lived hopes, and iron rule of a class system.
That's what's keeping society in the freezer on that island, with those who love traditions until death forces them to break away from that fossilized dream of keeping an Empire alive.
Talking about freezers, although I never choose frozen food, either for immediate consumption or for storage, I completely understand filling them with storage of meat, and other food products. It's common in the countryside, in the Netherlands, and in England, to use large freezers full of meat. Especially when it's for farmer's families, with cattle on short distance from the freezer, on the farm, after the end of their life, when their meat is meant for consumption.
I'm not sure if the present tribulations in our lives can be solved with guns though. I do understand that defence of your life when a predator arrives, animal or human, is a necessity in your living conditions.
My preference for storage of food is brown rice, dry lentils, dried leaves of nettle, ground-alder, dandelion, yarrow (stops bleeding too) and oats, dried raisins. Nowadays, the price of organic bread has risen much, and I'm picking up baking bread myself again. That's costing me half of the price for 1 bread, the oven shows up with 2 of those same breads.
I'm not sure what to think of the shouts online, saying "Prepare your home" "Make your home in good order" "Complete the work on your home" etc. For myself, I've used the 18 months of living in my home well, making it my home again, after sharing it for 9 years with sub-tenants.
An accomplishment I'm proud of is a new terrace, with flagstones, under low hanging branches of a beech, which offers me many more sunshine hours, and a chance to make a fire, possibly cook my food during power-outs, who knows? A fire pit in a large terracotta bowl with a cast iron lid is a comfortable source of warmth in late evenings.
Also, this creation gives me a tiny version of living outdoors, with the freedom to be self-reliant, when foraging our food isn't a choice but a must. Always, when I'm on my new terrace, without the presence of phone or laptop, I begin to think of hanging my hammock for the night, or place my camping bed on that spot, and sleep outdoors, keeping the fire burning in the firepit. Maybe stay awake all night, just for the fun of experiencing a night outdoors. I've done this in British communes, in 2012, sleeping in my hammock.
I remember, one night, when I had hung my hammock over a dry ditch between two fruit trees. Waking up in the night, hearing all sorts of animal noises, crawling, creeping, running. Badgers, and smaller animals. I didn't sleep much, but I loved to hear these sounds, while safe and sound hanging over that dry ditch, which was used as a highway for animals, at night.
Nature is the most nurturing company to me, in many ways. It's where I choose my volunteering work also. My most wishful thinking dream (with a magic touch to make it come true) is to organize a stow away sea-journey to Britain, find a spot on the South coast of Britain, preferably the Isle of Wight, with rocks, cliffs, where I'll find a cave, near the sea, but secluded by shrubs, and trees, dry enough to live in for the warmer part of the year. A proper habitat for this Capricorn, alive and kicking at an age 16 years beyond yours. You've got a good number of years to accomplish and maintain a good life for yourself, I assume. Wishing you good health, be safe.
wow sad that a big ocean is between us, I agree 200% with you and 16 years older. We could have been friends and rebels, have a wonderful day, OtreboR