By Barbara Loe Fisher
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Even though fathers are spending more time sharing the raising of children with mothers today, 1 national surveys show that women with minor children still remain the primary childcare givers in America.2 3 The ones who usually take children to doctors, mothers are on the front line soon expected to make decisions about giving babies as young as six months old the new genetically engineered Pfizer COVID-19 vaccine when the FDA predictably approves it for emergency use this spring. 4 5
Public health officials want doctors to give the mRNA vaccine, which forces the body’s cells to manufacture the SARS-COV-2 spike protein, to the most vulnerable age group, 6 the tiny babies and young children under five years old, whose immune systems and brains are not yet fully developed. 7 8 9 It is an age group that mothers historically have been the most responsible for nurturing and protecting from harm.
Fastest Development and Mass Administration of An Experimental Vaccine in History
The targeting of infants and toddlers for COVID vaccination comes two years after the US government declared a coronavirus public health emergency in January 2020 10 and then gave Pfizer and six other drug companies $9 billion dollars to manufacture a coronavirus vaccine at warp speed. 11 Most vaccines take at least 10 years to go through the development and testing licensing process before being approved by the US Food and Drug Administration (FDA) for distribution. 12 Pfizer spent just 248 days testing their experimental COVID vaccine using a never-before licensed technology, which injects synthetic mRNA encapsulated in lipid nanoparticles into the body to induce cells to make the SARS-COV-2 spike protein and become - in the words of the World Economic Forum - “vaccine production plants.” 13 14
In December 2020, the FDA granted Pfizer and its German corporation partner BioNTech, an Emergency Use Authorization – or EUA - to release the unlicensed mRNA vaccine for use by every person over 16 years old. 15 16 That EUA was quickly followed six months later by one for children as young as 12,17 then five months later with authorization for children as young as five. 18
It is the fastest development and mass administration of an experimental vaccine to healthy humans in history, 19 and the first vaccine to be distributed and recommended for mass use under an Emergency Use Authorization.20 Although the FDA fully licensed Pfizer’s Comirnaty vaccine in August 2021 as “safe, pure and potent” for 16 year olds, 21 it still is not officially licensed for children younger than that.
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FDA’s Emergency Use Authorization of COVID Vaccine Comes with Large Assumptions
By February 2022, only about 55 percent of children over age 12 in America had gotten two doses of the Pfizer COVID vaccine, while just 30 percent of five to 11 year-olds had received at least one dose.22 Perhaps mothers are not impressed with the dodgy rationale FDA officials used to justify handing Pfizer an EUA using vague language with large assumptions like it is “reasonable to believe” the vaccine “may be effective” and “reasonable to conclude based on the totality of the scientific evidence available” that the “known and potential benefits...outweigh the known and potential risks of the vaccine.” 23
Those kinds of sweeping caveats clearly demonstrate that an EUA allows a lower standard for scientific evidence of the product’s safety and effectiveness than full licensure. 24 In fact, it is not unreasonable to conclude that the Pfizer COVID vaccine is still an investigational product, still experimental whenever it is given to a child under 16 years old. 25 26
So far, parents in America are split down the middle when it comes to the idea of giving young children Pfizer’s new COVID-19 vaccine. Half of parents 27 are uncomfortable with injecting synthetic mRNA coated in lipid nanoparticles into the cells of their child’s body, which is supposed to prevent a bad case of COVID disease – but not necessarily prevent their child from being infected with the virus and transmitting it to others. 28 29 With researchers finding that many SARS-CoV-2 infections in young children are asymptomatic and go undetected, 30 and with evidence that natural immunity from infection is broad and persistent, 31 32 parents are asking legitimate questions about why their young children are candidates for this vaccine.
A recent survey found that half of parents were worried about (1) whether the vaccine has been studied long enough in children; (2) whether there are long term side effects; (3) whether the vaccine’s experimental mRNA technology is safe; (4) whether the vaccines work, and (5) the effect of short-term side effects.33 Research published in February 2022 revealed that one third of parents say they will “wait and see” before vaccinating a child under five years old and 26 percent say they will “definitely not” allow their infant or toddler to receive the COVID vaccine. 34
With the majority of parents worried about whether Pfizer’s COVID vaccine carries unacceptable risks, is effective, or is necessary for their child, what kind of information about COVID disease and the vaccine is being given to mothers taking children to pediatricians around the country?
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Are Mothers Being Given Accurate, Complete Information About COVID Vaccine?
Is the information accurate and complete?
Are pediatricians treating mothers with respect and allowing them to exercise voluntary informed consent to COVID vaccination on behalf of a minor child, or are mothers being threatened and punished if they say, “no thanks?” 35 How many doctors plan to deny medical care to children when their mothers decline the COVID vaccine?
A 2020 study reported that more than half of US pediatricians refuse to care for a child if their mothers decline to give the child even one of the four dozen doses of other vaccines CDC officials insist all children must get before age six. 36 37 38 39 To stop mothers from being able to exercise informed consent to vaccination on behalf of their children, medical trade associations have lobbied state legislatures to pass laws giving doctors permission to extract consent for any type of vaccination from children as young as 11 years old without the knowledge of their parents 40 and, in 2020, the District of Columbia was the first to pass that kind of law. 41 42 Five states (Alabama, Oregon, South Carolina, North Carolina and Rhode Island) have passed laws to give doctors the power to persuade children between 14 and 16 years old to get COVID vaccine without telling parents. 43
If you cringe thinking about whether your 11 year old or teenager is intellectually, psychologically and emotionally equipped to accurately weigh the potential benefits and risks of a vaccine and resist the pressure from a doctor telling them what to do, 44 you are not alone.
As a co-founder of the charitable National Vaccine Information Center established in 1982 to prevent vaccine injuries and deaths through public education, 45 I have never been more concerned about a new vaccine the government wants doctors to give to every infant and child. As a mother of three and now a grandmother, as a college-educated woman who completely trusted my pediatrician when I took my healthy two and a half year old son for a DPT shot in 1980 and then watched him suffer a convulsion, collapse and brain inflammation reaction that put him in a special education classroom, 46 I urge all mothers to become fully informed about the SARS-CoV-2 infection and the COVID-19 vaccine before making a vaccination decision for a child of any age.
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All Vaccines Come with Two Risks
Vaccines are pharmaceutical products that come with two risks: a risk the vaccine will cause a reaction that could cause harm, and a risk the vaccine will fail to protect against infection and transmission of a disease that could cause harm. Because we are all individuals born with different genes and environmental influences, the risks for disease complications or vaccine complications can be greater for some, depending upon genetic, epigenetic, environmental and other biological factors unique to the individual. 47 48 49 50
If the risks of COVID vaccination turn out to be 100 percent for your child – whether it is because the vaccine causes a severe reaction or fails to prevent severe complications of the disease – you should know that in June 2020, Congress completely shielded vaccine manufacturers and anyone administering the COVID vaccine from product liability and malpractice lawsuits in civil court. 51 52 So whatever happens, you will be on your own.
At the National Vaccine information Center, we do not make vaccine use recommendations, but we do defend without compromise the human right to exercise voluntary, informed consent to medical risk taking. 53 You have the moral right and should have the legal right to accept or refuse a vaccine for yourself or your minor child without being sanctioned in any way. 54
This commentary offers an overview of COVID disease and the vaccine, with a focus on the genetically engineered messenger mRNA COVID vaccine manufactured by Pfizer being recommended for children by federal government officials and medical trade associations in the U.S. I encourage you to check out the library of over 200 live-linked references anchoring this commentary on NVIC.org to verify the content and do your own research.
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Most Coronaviruses Cause Mild Symptoms Like the Common Cold
Coronaviruses are a group of diverse, single stranded RNA viruses that have been around for thousands of years and infect animals, as well as humans. Coronaviruses usually cause mild respiratory and gastrointestinal symptoms like those of the common cold,55 with the exception of Severe Acute Respiratory Syndrome (SARS) that emerged in China in 2002, and the coronavirus causing Middle East Respiratory Syndrome (MERS) identified in Jordan and Saudi Arabia in 2012 - both of which had high mortality rates.56
About 20 percent of cold or flu-like upper respiratory infections each year are caused by coronaviruses and there is evidence that many people already have at least partial natural immunity to common coronavirus infections. Some researchers think this may be one reason why the current SARS-CoV-2 infection is asymptomatic or mild for most healthy children and many adults, 57 and why COVID-19 tests can generate false positive results because the tests pick up evidence of previous coronavirus infections. 58 59
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Disagreement About Origins of SARS-CoV-2 and COVID Vaccine Effectiveness and Safety
Since early 2020, public health officials have insisted that the SARS-CoV-2 virus spontaneously jumped into a human out of a bat at a wet food market in China and the only way to end the pandemic is to lock down, mask up, and require everyone to be vaccinated. 60 61 62 63 64 65 There are prominent scientists, doctors, ethicists, attorneys, lawmakers and journalists around the world, who disagree with that view. They point out there is compelling evidence:
- that the SARS-CoV-2 virus was created in a lab and top health officials did not want the public to know about it; 66 67 68 69
- that fast tracked mRNA COVID vaccines have not been thoroughly tested by drug companies, which have failed to release all the clinical trial data, and both the companies and public health officials are downplaying serious vaccine-related reactions and deaths; 70 71 72 73 74 75 76
- that the most widely-used mRNA COVID manufactured by Pfizer and Moderna may prevent serious disease complications, but vaccinated people can still get infected with and transmit the new coronavirus to other people, 77 and any temporary protection from COVID disease wanes quickly after vaccination; 78
- that the SARS-CoV-2 infection is mostly asymptomatic or mild in healthy children and young adults 79 and that naturally acquired immunity is equal to or broader and longer lasting than COVID vaccine acquired artificial immunity; 80 81 82 83 and
- that governments have done more harm than good by locking down societies and creating masking and vaccine mandates; 84 85 86 87 88 89 90
Here are four questions you need to keep in mind when you are making a COVID-19 vaccine decision for your minor child:
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1. HOW SERIOUS IS COVID-19 DISEASE IN CHILDREN?
By February 2022, the new coronavirus had evolved from the original alpha variant that human populations had no immunological experience with, to the more transmissible and severe Delta variant that emerged in the summer of 2021, to the Omicron variant that became dominant in late 2021. 91 Omicron is highly contagious but causes fewer complications and hospitalizations than Delta, 92 and there is speculation that the fact so many people have developed various degrees of natural immunity to SARS-CoV-2 is one reason why hospitalizations and deaths are coming down in the U.S. 93 94
As of Feb. 14, 2022, COVID-19 death rates reported by states in the previous seven days ranged from 0.26 to about 1.5 deaths per 100,000 people.95 To put the worst case 1.5 COVID-related deaths per 100,000 people rate into perspective, the annual death rate for some of the leading causes of death in the U.S. in 2014 were: 193 deaths per 100,000 for heart disease; 186 per 100,000 for cancer; 46 per 100,000 for chronic respiratory disease; 24 per 100,000 for diabetes; 15 per 100,000 for drug overdoses. 96
Serious COVID-19 Complications Usually Occur in People Over 65 with Chronic Health Problems
At the outset of the coronavirus pandemic, it became obvious that most of the serious complications of COVID-19 disease leading to hospitalizations and death do not occur in children or healthy young adults, but in people over age 65, especially if they have one or more chronic health problems. In 2020, researchers projected that about 45 percent of the U.S. adult population was at increased risk for complications from SARS-CoV-2 infections because of underlying heart or respiratory disease, diabetes, hypertension and cancer. 97
One big study sponsored by the CDC looked at the connection between underlying medical conditions and severe illness among more than 500,000 adults with COVID-19 admitted to 800 US hospitals in 2020 and 2021. Researchers found that 95 percent of adult COVID patients had at least one underlying poor health condition like high blood pressure and obesity. 98 The strongest risk factors for death were obesity, anxiety and fear disorders, and diabetes with complications.
Children with chronic health problems are also at risk for COVID disease complications. The CDC states on its website that, “In the United States, more than 40% of school-aged children and adolescents have at least one chronic health condition, such as asthma, obesity, other physical conditions, and behavior/learning problems.” 99
Most Serious COVID-19 Complications Occur in Children with Underlying Chronic Conditions
A large cross-sectional study funded by the CDC examined the health records of more than 43,000 patients under the age of 18 with a COVID diagnosis who visited the emergency room or were admitted to 900 US hospitals in 2020 or January 2021. 100 The median age of child COVID patients was 12 years old. Researchers found that about 29 percent of the child COVID patients had underlying chronic conditions like asthma; obesity; and neurodevelopmental, depressive, anxiety and fear-related disorders. The strongest risk factors for hospitalization were type 1 diabetes and obesity. The strongest risk factors for severe COVID illness were type 1 diabetes and congenital cardiac and circulatory problems. Prematurity was a risk factor for severe COVID illness in children under two years old. 101 Those with a COVID diagnosis represented only about 1 percent of all children who visited an emergency room or were admitted to the hospital.
More than 81% of COVID related deaths in the U.S. have occurred in seniors over age 65 and deaths in that age group are 80 times higher than for people between 18 and 29.102 The COVID case fatality rate for children by February 2022 was measured at less than one percent in the U.S.103
Studies Show Most Healthy Infants and Children Have Either No or Mild COVID Disease Symptoms
Studies have shown that most healthy infants and children with COVID disease either have no symptoms or much milder symptoms than adults, which last about a week. 104 COVID disease symptoms in the majority of healthy children are similar to a cold or flu-like illness and range from fever, sore throat, fatigue and body aches to runny nose and congestion, headache, cough, nausea and diarrhea. As with most respiratory diseases, pneumonia is always a risk and, clearly, risks for COVID complications are higher for children with certain types of underlying chronic disease. 105
Severe complications of COVID-19 disease in some individuals appear to involve a hyper-inflammatory response by the immune system to infection with SARS-CoV-2. This can lead to cytokine storm involving elevated levels of circulating cytokines and immune-cell hyperactivation that can lead to severe respiratory distress and death if the inflammation does not resolve. 106 There is a condition called Multisystem Inflammatory Syndrome in Children (MIS-C) that has been reported rarely, and obese children are most at risk. Symptoms include a prolonged fever, unusual fatigue, vomiting and diarrhea, red skin rash, abdominal pain, red lips and eyes and swollen hands or feet.107
Children Who Get COVID Have Very Low Risk for Hospitalization, Long COVID or Death
While the majority of people diagnosed with COVID disease have mild to moderate symptoms, about 10 to 15 percent become severely ill and five percent become critically ill. Most recover in two to three weeks, but researchers estimate about one in five may have symptoms for five or more weeks and one in 10 people will have symptoms that last for 12 weeks or longer. 108 Symptoms of “long Covid,” can include fatigue, shortness of breath, muscle pain, joint pain, headache, cough, chest pain, altered smell and taste, diarrhea, difficulty thinking clearly, memory loss, anxiety and sleep disorders. About four percent of children may experience “long Covid” symptoms like fatigue, headache and loss of smell and the majority recover within eight weeks. 109
If infected with the SARS-CoV-2 virus, healthy children have a very low risk of being hospitalized or dying. A U.S. state data report published by the American Academy of Pediatrics on Feb. 3, 2022 found that out of about 1.2 million COVID-related hospitalizations, only three percent were children. Out of 821,369 reported COVID deaths in the U.S., 828 of those deaths or .01 percent were in children.110
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2. ARE THERE EFFECTIVE WAYS TO PREVENT OR TREAT COMPLICATIONS OF COVID DISEASE?
One of the great tragedies of the coronavirus pandemic over the past two years has been that very few drugs and effective medical protocols have been approved by the government to help people prevent or recover from the SARS-CoV-2 infection. About 95 percent of the public funds appropriated by the U.S. and other governments to fund the global response to the coronavirus pandemic were given to multi-national drug companies to develop and deliver vaccines, while only five percent was spent on exploring therapies to treat COVID disease.111 There are still very few FDA-approved drugs or therapies available for doctors to treat COVID disease.
Most of the anti-viral COVID drugs approved by the FDA under an EUA are very expensive, 112 113 114 and there are unanswered questions about risks and whether they work very well.115 116 117 118 In early 2020, practicing physicians searching for ways to help people with COVID began repurposing already licensed drugs for off-label use, a common practice that has been allowed under FDA law for many years. 119
Some Doctors Use Repurposed Licensed Drugs to Treat COVID
Some of the more affordable licensed drugs that have been repurposed by physicians to treat COVID over the past two years include the Nobel award winning anti-parasitic, anti-viral and anti-inflammatory drug Ivermectin. 120 121 122 123 124 125 Vitamins, minerals and supplements that have been used to help prevent or address COVID complications include the Vitamins D, 126 127 C, 128 and B complex; 129 magnesium; 130 quercetin; 131 132 melatonin, 133 curcumin, 134 zinc, 135 NAC, 136 probiotics, 137 Omega 3s, 138 glutathione 139 and aspirin. 140
As with all drugs and supplements, it is important to have a knowledgeable doctor direct treatment in the appropriate doses and for the right length of time, because what may work and is safe at one stage of the disease may not be during another stage. The Front Line Covid-19 Critical Care Alliance (FLCCCA) 141 and World Council for Health. 142 are two groups of doctors who have developed COVID-19 treatment protocols that are not endorsed by government health officials but are being used by a number of health professionals around the world to treat adults and children with COVID.
High Mortality Rate for COVID Patients Hospitalized in US
With an average 38 percent mortality rate for seriously ill COVID patients admitted to U.S. hospitals in 2020,143 and with COVID patients who are put on a ventilator experiencing a 45 to 85 percent mortality rate, 144 145 146 it is no wonder independent doctors have been exploring options for reducing COVID complications and keeping patients out of hospitals. Yet, these doctors are being criticized by public health officials discouraging the use of repurposed licensed drugs like Ivermectin 147 and over-the-counter supplements 148 that peer reviewed studies have shown either prevent severe disease and improve, or have the potential to improve, survival. 149 Medical boards in some states are trying remove the medical licenses from those doctors, 150 and it can be difficult to find a doctor in the U.S. willing to depart from the few government approved medical protocols for treating COVID. 151
The National Institutes of Health warns that:152
“Research hasn’t clearly shown that any dietary supplement helps prevent COVID-19 or can decrease the severity of COVID-19 symptoms. Only vaccines and medications can prevent COVID-19 and treat its symptoms.”
No Drugs Specifically Approved by FDA for Treatment of COVID-19 in Children
The only guidelines published by the Centers for Disease Control for treatment of children with COVID are dated December 2020 and state, “Currently, there are no drugs specifically approved by the FDA for treatment of COVID-19 in children.” 153 NIH has a child treatment guide, which states that “Most children with SARS-CoV-2 infection will not require any specific therapy” and “There are limited data on the pathogenesis and clinical spectrum of COVID-19 disease in children.” It goes on to say that:
“There are no pediatric data from placebo-controlled randomized clinical trials and limited data from observational studies to inform the development of pediatric-specific recommendations for the treatment of COVID-19.” 154
After lockdowns and forced masking and a year that saw many Americans subjected to mandatory COVID vaccination to enter public spaces and keep their jobs, it is very sad that government officials have done so little to investigate and approve therapies to address COVID disease. One political explanation is that under FDA regulations, drug companies cannot receive emergency use authorization to distribute fast tracked experimental vaccines (or drugs) if there are “adequate, approved, and available alternatives.” 155
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3. HOW EFFECTIVE IS PFIZER’S COVID VACCINE?
After the coronavirus pandemic was declared by public health officials in early 2020 and governments asked drug companies to fast track development of experimental COVID vaccines, the FDA issued guidelines assuring the companies that vaccine trials would only have to demonstrate “at least 50 percent” efficacy in preventing severe COVID-19 disease. There was no requirement for companies to prove their COVID vaccines prevent infection and transmission of the SARS-CoV-2 virus. 156 157 Perhaps that is one reason why the vaccines are called COVID vaccines and not SARS-CoV-2 vaccines.
But the general public did not and still does not understand the difference. That is because for more than a century, people have been carefully taught to believe that a vaccine produces artificial immunity in the body to prevent transmission of contagious diseases to other people. 158
CDC Changed Definition of “Vaccine” and “Vaccination” to Remove Reference to “Immunity”
CDC officials frequently have referred to vaccines as “immunizations.” 159 But in 2021, the CDC suddenly changed its definition of “vaccine” from “a product that stimulates a person’s immune system to produce immunity to a specific disease” to “a preparation that is used to stimulate the body’s immune response against diseases.” 160 The Merriam Webster Dictionary also changed its definition of “vaccine” to eliminate the concept that a vaccine stimulates “immunity” and replaced it with the concept that vaccines create an “immune response.”161
Up until now, the words “vaccine” and “vaccination” have been synonymous with creating “artificial immunity” in humans and animals. 162 The rewriting of that definition to admit that vaccines cannot be presumed to confer immunity - only modify the person’s immune response - is stunning because mandatory vaccination laws historically have been based on the common belief that all infants and children must get vaccinated to create “herd immunity” and prevent the transmission of contagious diseases within a community.163 164
If the definition of “vaccine” and “vaccination” no longer includes the concept of immunity, 165 then the definitions of vaccine “efficacy” and “effectiveness” have been forever changed as well.166 167
Public Misled Into Believing that Pfizer COVID Vaccine Reliably Prevents SARS-CoV-2 Infection and Transmission
To obtain the EUA in late 2020, Pfizer published clinical trial data involving about 43,000 participants over age 16, with more than 21,000 of them injected with the company’s experimental mRNA Covid vaccine. Pfizer said the data showed that two doses of the vaccine achieved a 95 percent efficacy for preventing severe COVID disease.168 169 Most mainstream media reports publicizing the Pfizer clinical trial results misled the public into believing that a 95 percent “efficacy” rate meant the vaccine reliably prevented SARS-CoV-2 infection. 170 Americans obeying mask mandates put into place before the vaccine was released, assumed that they would be able to ditch the mask and stop social distancing once they got vaccinated. 171
But in early 2021 when CDC officials did not back away from mask mandates for vaccinated persons, people started suspecting something was wrong about that assumption. Fully vaccinated people were told to keep the masks on and socially distance like unvaccinated people. 172
The logical question was: why do fully vaccinated people have to worry about getting infected or infecting other people?
The answer to that question became obvious when study after study published in the medical literature since December 2020 showed that two or three doses of Pfizer’s mRNA COVID vaccine does not reliably prevent symptomatic or asymptomatic infection and transmission of SARS-CoV-2 virus, and the vaccine has a very short shelf life for protection against COVID disease, waning within a few months of vaccination. 173 174 175 While that reality sets in, studies are revealing that naturally acquired immunity from the new coronavirus infection is broad and long lasting, 176 177 178 179 180 perhaps two years or more. 181
More COVID Booster Shots or Annual Re-Vaccination?
In fact, within four months of Pfizer’s COVID vaccine being approved by FDA for distribution, in April 2021 the company’s CEO called for a third shot – a booster dose – and suggested it was possible vaccinated people would have to get revaccinated every year. 182 Seven months later, the FDA dutifully approved the Pfizer booster shot for emergency use by everyone over 18 years old, 183 and on Jan. 3, 2022, expanded the EUA to allow a third booster shot for children as young as 12 years old. 184
Now there is talk about a fourth booster shot. 185 And the Pfizer CEO is once again calling for annual COVID vaccinations in the future. 186
On Feb. 1, 2022, Pfizer applied for an EUA to give its COVID vaccine to infants and young children between six months and five years old. 187 But, within 10 days, the request was suddenly withdrawn after indications that two three microgram doses of the vaccine did not prevent COVID disease symptoms in that age group and a third dose would be required to demonstrate efficacy. 188 189
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4. HOW REACTIVE IS THE PFIZER VACCINE AND ARE THERE SERIOUS RISKS?
After the FDA gave emergency use permission to Pfizer in December 2020 to distribute their COVID vaccine, the nonprofit group Public Health and Medical Professionals for Transparency filed a Freedom of Information Act (FOIA) request for the FDA to immediately release 450,000 pages of Pfizer vaccine testing data that the agency relied upon to grant the EUA. FDA officials refused the request, claiming it would take them 75 years to release all the trial data to the public. A lawsuit was filed and, on Jan 6, 2022, a Texas federal judge ordered the FDA to release 55,000 pages every 30 days until all the requested pages were made public. 190
The need for full public disclosure was reinforced by an allegation by a whistleblower, who had worked for a subcontractor involved in the first COVID vaccine clinical trial Pfizer conducted in 2020. She charged that there were serious irregularities in the trial, including falsification of data, lack of monitoring of trial participants after vaccination and failure to immediately follow up of patients who experienced adverse events. 191
Questions About Pfizer COVID Vaccine Safety Testing, Lack of Transparency
Pfizer has been haunted by questions about what it does and does not know about the reactivity and long-term side effects of its COVID vaccine ever since the FDA granted emergency use authorization after only nine months of testing. 192 193 194 To demonstrate safety, drug companies historically have been required to first test the experimental vaccine for toxicity in animals, followed up by Phase 1 and 2 human clinical trials to test the vaccine on a few hundred volunteers for detection of common side effects; then progress to Phase 3 trials that involve thousands of peopl