FDA Contact Information - Flood Their Phones With Opposition to the CLOTSHOT Approval 1-888-INFO-FDA (1-888-463-6332)
Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002
To report adverse reactions or other problems with FDA-regulated products, contact the FDA Consumer Complaint Coordinator for the state in which you reside:
Alabama 866-289-3399 Alaska 800-353-3965 (toll free) Arizona 303-236-3044 Arkansas 855-630-2112 (toll free) California (Northern)— zip codes 936xx & higher; and zip codes not covered by southern CA 510-337-6741 California (Southern)— zip codes 90xxx - 92xxx, 93000-93199, 93400-93499, 93510, 93532-93539 949-608-3530 Colorado 303-236-3044 Connecticut 800-891-8295 (toll free) Delaware 877-689-8073 (toll-free) District of Columbia 410-779-5713 Florida 866-337-6272 (toll free) Georgia 404-253-1169 Hawaii 808-522-8011 X1100 Idaho 800-353-3965 (toll free) Illinois 312-353-7840 Indiana 313-393-8189 Iowa 855-202-9780 (toll free) Kansas 855-202-9780 (toll free) Kentucky Toll-free in KY only: 800-437-2382 513- 679-2700 Louisiana 866-289-3399 Maine 800-891-8295 (toll-free) Maryland 410-779-5713 Massachusetts 800-891-8295 (toll-free) Michigan 313-393-8189 Minnesota 612-758-7221 Mississippi 866-289-3399 Missouri 855-202-9780 (toll free) Montana 800-353-3965 (toll-free) Nebraska 855-202-9780 (toll free) Nevada 510-337-6741 New Hampshire 800-891-8295 (toll-free) New Jersey 973-331-4998 New Mexico 303-236-3044 New York 866-446-9055 (toll-free) North Carolina 404-253-1169 North Dakota 612-758-7221 Ohio Toll free in OH only: 800-437-2382 513- 679-2700 Oklahoma 855-630-2112 (toll free) Oregon 800-353-3965 (toll-free) Pennsylvania 877-689-8073 (toll-free) Rhode Island 800-891-8295 (toll-free) South Carolina 404-253-1169 South Dakota 612-758-7221 Tennessee 866-289-3399 Texas 855-630-2112 (toll free) Utah 303-236-3044 Vermont 800-891-8295 (toll-free) Virginia 410-779-5713 Washington 800-353-3965 (toll-free) West Virginia 410-779-5713 Wisconsin 612-758-7221 Wyoming 303-236-3044 Puerto Rico, U.S. Virgin Islands 800-332-0127 (toll-free)
_________________ What is life? It is the flash of a firefly in the night, the breath of a buffalo in the wintertime. It is the little shadow which runs across the grass and loses itself in the sunset. With deepest respect ~ Aloha & Mahalo, Carol
1h 23 Aug 2021 - 1;32 pm est · "There are at least 100 million people in this country who haven't gotten the vaccine.
If you haven't to this point, there's a 99% chance you never will.
We know that. They know that.
They claim that FDA approval will convince those who are hesitant to go ahead and jab themselves.
That's not going to happen.
We know that. They know that.
So what is the approval for?
They want to encourage businesses, hospitals, etc. to mandate the vaccine.
They can't directly force it on the entire country, so they plan on making it impossible to exist in society without it.
This is their final push.
Regardless of how difficult or uncomfortable this may become,
always remember that we are the majority and if we stand as one we cannot be defeated.
Your freedom and your children's future are worth every battle.
Every bead of sweat relinquished is a seed of hope planted.
Every tear shed becomes nourishment for those seeds.
Every speech from an angry citizen is a message of righteous indignation that will reverberate into future generations.
Every act of defiance against tyranny is an example set for our kids to never allow this to happen again.
As Reagan once said, freedom isn't passed through the bloodline. It will forever remain our duty to teach the upcoming generations what it means to be an American Patriot and how vitally important it is that we never lose this great nation to evil tyrants who wish to destroy the world's beacon of hope and freedom.
We physically outnumber them. We mentally outclass them. Most importantly God is on our side.
Americans thrive with their backs against the wall. In fact it serves as fuel for the star spangled fire that forever rages within our hearts. Each and every attack on our freedom is a stark reminder that we must never stop fighting to maintain it.
Fight now or forever hold your peace.
The window is open. We've been given the opportunity to create a beautiful new world.
A world where the power truly lies with the people.
A world of abundance and prosperity. A world governed by love and light.
Sieze the moment and run with it.
The alternative is NOT a place any of us want to live in."
New Study out of Vietnam, Vaccinated Hospital Workers have 250 times higher viral load than original virus (super, super spreaders)
Transmission of SARS-CoV-2 Delta Variant Among Vaccinated Healthcare Workers, VietnamBackground: Data on breakthrough SARS-CoV-2 Delta variant infections are limited.
Methods: We studied breakthrough infections among healthcare workers of a major infectious diseases hospital in Vietnam. We collected demographics, vaccination history and results of PCR diagnosis alongside clinical data. We measured SARS-CoV-2 (neutralizing) antibodies at diagnosis, and at week 1, 2 and 3 after diagnosis. We sequenced the viruses using ARTIC protocol.
Findings: Between 11th–25th June 2021 (week 7–8 after dose 2), 69 healthcare workers were tested positive for SARS-CoV-2. 62 participated in the clinical study. 49 were (pre)symptomatic with one requiring oxygen supplementation. All recovered uneventfully. 23 complete-genome sequences were obtained. They all belonged to the Delta variant, and were phylogenetically distinct from the contemporary Delta variant sequences obtained from community transmission cases, suggestive of ongoing transmission between the workers. Viral loads of breakthrough Delta variant infection cases were 251 times higher than those of cases infected with old strains detected between March-April 2020. Time from diagnosis to PCR negative was 8–33 days (median: 21). Neutralizing antibody levels after vaccination and at diagnosis of the cases were lower than those in the matched uninfected controls. There was no correlation between vaccine-induced neutralizing antibody levels and viral loads or the development of symptoms.
Interpretation: Breakthrough Delta variant infections are associated with high viral loads, prolonged PCR positivity, and low levels of vaccine-induced neutralizing antibodies, explaining the transmission between the vaccinated people. Physical distancing measures remain critical to reduce SARS-CoV-2 Delta variant transmission.
_________________ What is life? It is the flash of a firefly in the night, the breath of a buffalo in the wintertime. It is the little shadow which runs across the grass and loses itself in the sunset. With deepest respect ~ Aloha & Mahalo, Carol
Chairman of Tokyo Metropolitan Medical Association Declares During Surge, "Time for Ivermectin is Now!
In Dr. Ozaki’s recent speech, he declared that ivermectin has demonstrated significant benefits in reducing infections and deaths where the regimen is prophylactically administered for another indication. The head of the Metropolitan Medical Association declared that while clinical trials were important, it was time to green light doctors to prescribe ivermectin in association with giving the patient informed consent.
Vaccinated People Are At Risk Of New Variants..Vaccinated People Should Be Put In Quarantine& Should Be Isolated From The Society. Unvaccinated People Are Not Dangerous But Vaccinated People Are Dangerous To Others!"
_________________ What is life? It is the flash of a firefly in the night, the breath of a buffalo in the wintertime. It is the little shadow which runs across the grass and loses itself in the sunset. With deepest respect ~ Aloha & Mahalo, Carol
Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs
Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world. Its mission includes ensuring that new medical treatments reach the public as quickly as possible while simultaneously ensuring that new treatments are both safe and effective. In the face of urgent consumer need, the FDA has faced criticism that its processes are too lengthy and costly and that the time to new drug release is significantly longer in the United States than in other Western countries. Calls from the public to loosen FDA regulations to facilitate more rapid approval of drugs and devices have been countered by the occurrence of patient harm and deaths after some approved drugs have reached the marketplace.
New drug and device approval in the United States take an average of 12 and 7 years, respectively, from pre-clinical testing to approval. Costs for development of medical devices run into millions of dollars, and a recent study suggests that the entire cost for a new drug is in excess of $1 billion. For investigators seeking approval for new drugs and devices, FDA processes can be formidable. This 2-part series is intended to provide an overview of the steps involved in bringing new drugs and devices through the FDA process. Part 1 concerns the process of new drug approvals. Part 2 continues with approval of medical devices.
_________________ What is life? It is the flash of a firefly in the night, the breath of a buffalo in the wintertime. It is the little shadow which runs across the grass and loses itself in the sunset. With deepest respect ~ Aloha & Mahalo, Carol
