Cleveland Clinic study finds natural Covid immunity better than fully vaccinated, No reason to vaccinate previously infected, Fully vaccinated still getting Covid and adverse reactions
“two papers published May 19 in the journal of Hospital Pediatrics found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.”...The Defender
“it is universally known that children virtually never die from COVID-19 and given that children have a very strong immune system, they are more likely than adults to have an over-reaction to the shot.”…Dr. Steven Roth
“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells
From The Defender June 9, 2021.
“Cleveland Clinic: Already Had COVID? Vaccine Provides No Added Benefit
A Cleveland Clinic study of the effectiveness of COVID vaccines in people with a history of previous SARS-CoV-2 infection and those without found those who had COVID but weren’t vaccinated appeared to have acquired strong natural immunity.
A new preprint study by the Cleveland Clinic found people previously infected with SARS-CoV-2 were less likely to be reinfected than fully vaccinated individuals who never had the virus — suggesting the vaccine is of no benefit to people who already had COVID.
The Cleveland Clinic recently studied the effectiveness of COVID-19 vaccination among people with a history of previous SARS-CoV-2 infection and those without. The purpose of the study was to evaluate the necessity of COVID vaccination in persons previously infected with SARS-CoV-2.
The study, available on medRxiv, provides insight into how the immune system protects the body once a COVID infection is confirmed, the Cleveland Clinic said.
The clinic studied 52,238 employees. Of those, 49,659 never had the virus and 2,579 had COVID and recovered. Of the 2,579 who previously were infected, 1,359, or 53%, remained unvaccinated, compared with 41%, or 22,777 who were vaccinated.
The cumulative incidence of SARS-CoV-2 infection remained almost zero among three groups — those previously infected who remained unvaccinated; those previously infected who were vaccinated; and those previously uninfected who were vaccinated — compared with a steady increase in cumulative incidence among previously uninfected subjects who remained unvaccinated.
Of all infections during the study period, 99.3% occurred in participants who were not infected previously and remained unvaccinated. In contrast, 0.7% of infections occurred in participants who were not previously infected but were currently vaccinated.
Significantly, not one of the 1,359 previously infected subjects who remained unvaccinated had a SARS-CoV-2 infection over the duration of the study, according to the Cleveland Clinic.”
Pfizer emergency authorization from FDA for use by children fraudulently obtained, “Serious violations and manipulations of trial protocol”, 3 children in test had psy diagnosis
“two papers published May 19 in the journal of Hospital Pediatrics found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.”...The Defender
“it is universally known that children virtually never die from COVID-19 and given that children have a very strong immune system, they are more likely than adults to have an over-reaction to the shot.”…Dr. Steven Roth
“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells
From America’s Frontline Doctors June 8, 2021.
“‘Serious violations and manipulations of trial protocol’: How Pfizer obtained FDA emergency authorization for children
Analysis and comparison of the review document submitted by Pfizer to the US Food and Drug Administration, on the basis of which the FDA gave the green light to expand the emergency permit for vaccination, as well, for children aged 12-15 (1), as opposed to the study protocol in children (2, 3), reveal concerning findings, including violations of the protocol established by Pfizer itself, and no less serious, designing the trial protocol in a way that will allow the company to present as positive findings as possible in terms of vaccine safety in children.
Violation of protocol conditions – How did children with a psychiatric diagnosis get to be included in the study?
According to the review document submitted by Pfizer to the FDA, four of the 1131 children in the study arm who received Pfizer-BioNTech COVID-19 Vaccine suffered from serious adverse events (“SAEs”) – that is, events in which at least one criterion was met: caused death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, a congenital anomaly/birth defect.
Of these four children, three had such severe depression, that they were hospitalized shortly after vaccination (in the first 7 days after the first dose, in the second only one day after the second dose, and in the third 15 days after the first dose, respectively).”
“The consequence of this finding is extremely worrying, as it means that one in every 350-400 children who are vaccinated might suffer from severe depression and need hospitalization.
To reassure us, Pfizer notes in its review document that in fact, all three children had a pre-existing diagnosis of anxiety and depression. Moreover, they explain – all three actually reported a selective serotonin reuptake inhibitor (SSRI) that began within 1-2 months prior to vaccination.
“Worsening suicidal ideas with initial SSRI treatment in adolescents”, they explain, “is a recognized risk and provides a reasonable alternative explanation for depression exacerbation in these BNT162b2 recipients”. So here you go – why blame the vaccine, when there is a perfectly reasonable and logical alternative explanation for the exacerbation of their depression?”
Covid vaccine spike protein can cause organ damage “We made a big mistake”, Scientific research proves pathogenic protein gets into blood, “almost entirely responsible for the damage to the cardiovascular system”
“two papers published May 19 in the journal of Hospital Pediatrics found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.”...The Defender
“it is universally known that children virtually never die from COVID-19 and given that children have a very strong immune system, they are more likely than adults to have an over-reaction to the shot.”…Dr. Steven Roth
“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells
From The Defender June 3, 2021.
‘”We Made a Big Mistake’ — COVID Vaccine Spike Protein Travels From Injection Site, Can Cause Organ Damage
Research obtained by a group of scientists shows the COVID vaccine spike protein can travel from the injection site and accumulate in organs and tissues including the spleen, bone marrow, the liver, adrenal glands and in “quite high concentrations” in the ovaries.
COVID vaccine researchers had previously assumed mRNA COVID vaccines would behave like traditional vaccines. The vaccine’s spike protein — responsible for infection and its most severe symptoms — would remain mostly in the injection site at the shoulder muscle or local lymph nodes.
But new research obtained by a group of scientists contradicts that theory, a Canadian cancer vaccine researcher said last week.
“We made a big mistake. We didn’t realize it until now,” said Byram Bridle, a viral immunologist and associate professor at University of Guelph, Ontario. “We thought the spike protein was a great target antigen, we never knew the spike protein itself was a toxin and was a pathogenic protein. So by vaccinating people we are inadvertently inoculating them with a toxin.”
““It’s the first time ever scientists have been privy to seeing where these messenger RNA [mRNA] vaccines go after vaccination,” Bridle said in an interview with Alex Pierson where he first disclosed the data. “Is it a safe assumption that it stays in the shoulder muscle? The short answer is: absolutely not. It’s very disconcerting.”
The Sars-CoV-2 has a spike protein on its surface. That spike protein is what allows it to infect our bodies, Bridle explained. “That is why we have been using the spike protein in our vaccines,” Bridle said. “The vaccines we’re using get the cells in our bodies to manufacture that protein. If we can mount an immune response against that protein, in theory we could prevent this virus from infecting the body. That is the theory behind the vaccine.”
“However, when studying the severe COVID-19, […] heart problems, lots of problems with the cardiovascular system, bleeding and clotting, are all associated with COVID-19,” he added. “In doing that research, what has been discovered by the scientific community, the spike protein on its own is almost entirely responsible for the damage to the cardiovascular system, if it gets into circulation.”
When the purified spike protein is injected into the blood of research animals, they experience damage to the cardiovascular system and the protein can cross the blood-brain barrier and cause damage to the brain, Bridle explained.
The biodistribution study obtained by Bridle shows the COVID spike protein gets into the blood where it circulates for several days post-vaccination and then accumulates in organs and tissues including the spleen, bone marrow, the liver, adrenal glands and in “quite high concentrations” in the ovaries.
“We have known for a long time that the spike protein is a pathogenic protein, Bridle said. “It is a toxin. It can cause damage in our body if it gets into circulation.””
Tony Shaffer interview: “Bill Barr called me and said you need to give the investigation up”, “there was mass ballot fraud”, Shaffer investigated the 2020 election
“Trump’s not gonna win. I made f*cking sure of that!”...Eric Coomer, executive with Dominion Voting Systems
“The certification of Arizona’s FALSE results is unethical and knowingly participating in the corruption that has disenfranchised AZ voters,” …Jenna Ellis
“Maricopa County Elections Witness Testifies that Dominion Ran Entire Election – County Officials and Observers NEVER HAD Access or Passwords!”…GateWay Pundit
Lt. Colonel Tony Shaffer was interviewed by Chase Geiser recently.
Shaffer investigated the 2020 election and some of the more alarming remarks he made were:
“Bill Barr called me and said you need to give the investigation up”
“LtCol Anthony (Tony) Shaffer (retired), is the President of the London Center for Policy Research, a New York Times bestselling author and CIA trained intelligence operations officer with 35 years of experience in global and national security. In his think-tank work he is an advisor to senior members of the White House, the Intelligence Community, Pentagon and key members of Congress. He also works with National Geographic as an Advising Producer and Co-Producer of the series “Chain of Command”. In 2017 he became the Homeland Security Advisor to the Stafford County Sheriff’s Department in Virginia and works as its member of the NYPD Counterterrorism Bureau’s expanded task force.
As a senior DoD intelligence officer, he received the Bronze Star and the Commander’s Award for Civil Service for his work on cutting edge, highly classified, DoD special activities. He has detailed operational and policy expertise regarding the full spectrum of strategic national security issues; from being a pioneer in cyber operations, to being at cutting edge of U.S. counterterrorism efforts and helping develop and use of “weaponized technology”.
Tony has commanded and directed several key operational intelligence organizations that conducted “compartmented” (aka black) operations. These include Special Mission Task Force STRATUS IVY, that conducted direct support to DoD compartmented activities (OSD, SOCOM, JSOC, Army) which was focused on offensive information operations. In addition, he commanded Field Operating Base (FOB) Alpha, a joint DIA/CIA unit conducting classified collection and special operations support regarding terrorists just after the 9/11 attacks.
During the 1980s, Tony was a counterintelligence officer. He deployed to Germany to conduct counterterrorism operations in 1985 as part of REFORGER and worked in New York City as part of Army’s anti‐terrorism efforts during OPSAIL 1986 – the re‐opening of the Statue of Liberty. He also worked to monitor Soviet military officers visiting the United States during the INF Treaty missile eliminations, as well as a reserve tour with Army Foreign Counterintelligence Activity (FCA).
Lt Col Shaffer transitioned into the Foreign Intelligence area of focus with his graduation from “The Farm” in 1988, and his work at Air Force Special Activities Center (AFSAC) where he worked as a case officer. He was brought to active duty by the Army for the first Gulf War in 1991 and transitioned into the Army’s Military Intelligence Excepted Career Program (MIECP) where he became the chief of Army’s global Controlled HUMINT collection program and ran specific Special Access Program (SAP) operations that netted highly. As a reservist during this period he was the senior HUMINT advisor to the J2/Senior
Intelligence Officer of Joint Interagency Task Force East (JIATF‐E) that conducted counter‐drug operations in the Transit Zone. He successfully integrated highly specialized hybrid technology/human intelligence operations to obtain high value intelligence to support operational forces.
In 1995, Tony transitioned to Defense Intelligence Agency (DIA), as part of the consolidation of all Service (Army, Navy, Air Force, USMC) HUMINT into the Department of Defense. He became a Senior Intelligence Officer (Operations) and created Task Force STRATUS IVY that conducted the full spectrum of support to Department of Defense, Special Operations Command and other non‐ DoD agencies. This included support to the controversial counterterrorism project known as ABLE DANGER – a pre‐9/11 offensive operation suite designed to detect, degrade and counter Al Qaeda capabilities. In 2001, just after the 9/11 attacks, he was returned to active duty for a 30-month period, during which he commanded a DIA special mission operating base (OB Alpha) and had two successful combat tours to Afghanistan.
During his two successful, undercover, combat tours he participated in the search for senior Al Qaeda leadership in Afghanistan. These operations provide him with a unique viewpoint on terrorism and its roots in southwest Asia.”
18 CT teens hospitalized for heart inflammation after Covid vaccinations, Gregory Hatton diagnosed with pericarditis inflammation of the tissue surrounding the heart, Myocarditis
“two papers published May 19 in the journal of Hospital Pediatrics found pediatric hospitalizations for COVID were overcounted by at least 40%, carrying potential implications for nationwide figures used to justify vaccinating children.”...The Defender
“it is universally known that children virtually never die from COVID-19 and given that children have a very strong immune system, they are more likely than adults to have an over-reaction to the shot.”…Dr. Steven Roth
“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells
From The Defender May 26, 2021.
“18 Connecticut Teens Hospitalized for Heart Problems After COVID Vaccines, White House Says Young People Should Still Get the Shots
The mother of 17-year-old Gregory Hatton, diagnosed with pericarditis within days of his second dose of the vaccine, said her son “basically has a heart condition now and it’s terrifying.”
“One week after the Centers for Disease Control and Prevention (CDC) announced it was investigating heart inflammation in recently vaccinated young adults, Connecticut reported 18 new cases of heart problems among teens who had received a COVID vaccine.
“It’s terrifying,” said Hatton. Her son started complaining of severe chest pain three days after his second vaccine dose. It worsened on the fourth day, causing back pain.
After blood work and an x-ray, doctors diagnosed Gregory with pericarditis, an inflammation of the tissue surrounding the heart that can cause sharp chest pain and other symptoms.”
“Doctors couldn’t confirm Gregory’s condition was caused by the COVID vaccine, but two more recently vaccinated patients presented to the hospital with similar symptoms. A spokesperson from Connecticut Children’s said patients have presented with both pericarditis and myocarditis”
CDC reviews post Covid vaccination myocarditis in adolescents and young adults, “3rd leading cause of Sudden Death in children and young adults”, “inflammation enlarges and weakens the heart, creates scar tissue”
“it is universally known that children virtually never die from COVID-19 and given that children have a very strong immune system, they are more likely than adults to have an over-reaction to the shot.”…Dr. Steven Roth
“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells
“By looking at the difference between adults and children in these quarantines, deCODE found that children play a minor role in transmission.”…Iceland Covid transmission study
From the CDC.
“The VaST session on May 17, 2021, included several presentations on myocarditis following mRNA vaccines, from the Department of Defense (DoD), the Vaccine Adverse Event Reporting System (VAERS), and Vaccine Safety Datalink (VSD). There were also brief updates from the Veteran’s Administration (VA) and the Clinical Immunization Safety Assessment (CISA) groups about their plans for future investigation of myocarditis.
VaST concluded that there are relatively few reports of myocarditis to date and that these cases seem to occur:
predominantly in adolescents and young adults,
more often in males than females,
more often following dose 2 than dose 1, and
typically within 4 days after vaccination.
Most cases appear to be mild, and follow-up of cases is ongoing.
Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates. However, VaST members felt that information about reports of myocarditis should be communicated to providers.
VaST discussed:
Further information should be collected through medical record review about potential myocarditis cases that were reported into VAERS.
Information about this potential adverse event should be provided to clinicians to enhance early recognition and appropriate management of persons who develop myocarditis symptoms following vaccination.
Collaboration between infectious diseases, cardiology, and rheumatology specialists is needed to provide guidance on diagnosis, treatment, and management of myocarditis.”
“In simple terms, myocarditis is a disease that causes inflammation of the heart muscle. This inflammation enlarges and weakens the heart, creates scar tissue and forces it to work harder to circulate blood and oxygen throughout the body.
While we often associate cardiovascular conditions with elderly populations, myocarditis can affect anyone, including young adults, children and infants. In fact, it most often affects otherwise healthy, young, athletic types with the high-risk population being those of ages from puberty through their early 30’s, affecting males twice as often as females. Myocarditis is the 3rd leading cause of Sudden Death in children and young adults.”
America’s Frontline Doctors AFLDS file motion for temporary restraining order against covid vaccine emergency use authorization EUA in children under age 16, US District Court Northern District of Alabama
“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells
“By looking at the difference between adults and children in these quarantines, deCODE found that children play a minor role in transmission.”…Iceland Covid transmission study
“The FDA has approved the Covid vaccine for use on children yet only half of their employees have embraced it and patients are not being fully informed of risks.”…Citizen Wells
From The Defender May 21, 2021.
“Physicians Group Files Motion to Halt Use of COVID Vaccines in Children
Citing well-documented harms and lack of long-term safety testing, America’s Frontline Doctors Wednesday filed a motion in the U.S. District Court for the Northern District of Alabama requesting a temporary restraining order against the Emergency Use Authorization of COVID vaccines in teens and children under 16.”
The case will challenge the EUAs for the injections on several counts, based on the law and scientific evidence that the EUAs should never have been granted, the EUAs should be revoked immediately, the injections are dangerous biological agents that have the potential to cause substantially greater harm than the COVID-19 disease itself, and that numerous laws have been broken in the process of granting these EUAs and foisting these injections on the American people.
AFLDS Founder Dr. Simone Gold spoke about the reasons for filing the motion: “We doctors are pro-vaccine, but this is not a vaccine,” she said. “This is an experimental biological agent whose harms are well-documented (although suppressed and censored) and growing rapidly, and we will not support using America’s children as guinea pigs.”
She continued:
“We insist that the EUA not be relinquished prematurely; certainly not before trials are complete — Oct. 31, 2022 for Moderna and April 27, 2023 for Pfizer. We are shocked at the mere discussion of this, and will not be silent while Americans are used as guinea pigs for a virus with survivability of 99.8% globally and 99.97% under age 70.
“Under age 20 it is 99.997% — ‘statistical zero.’
“There are 104 children age 0-17 who died from COVID-19 and 287 from COVID + Influenza – out of ~72 million. This equals zero risk. And we doctors won’t stand for children being offered something they do not need and of whom some unknown percentage will suffer.””
CDC director Walensky admits Covid deaths inflated, 6% of all deaths attributed to COVID-19 were Covid only, 94 percent had 2 to 3 serious ailments and were mostly aged
“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells
“VAERS received 4,434 reports of death (0.0017%) among people who received a COVID-19 vaccine.”...CDC May 11, 2021
“The FDA has approved the Covid vaccine for use on children yet only half of their employees have embraced it and patients are not being fully informed of risks.”…Citizen Wells
From GateWay Pundit May 17, 2021.
“CDC Director Finally Admits that COVID Cases are Hugely Over-Counted — Just as Gateway Pundit and Donald Trump Reported in August”
“Based on CDC numbers in Ausust only 6% of all deaths attributed to COVID-19 were instances where the only factor in the individual’s death was due to COVI9-19.”
“For all the other deaths reported by the CDC linked to COVID-19, the individuals who passed away had 2-3 other serious illnesses or co-morbidities.
“On Sunday CDC Director Rochelle Walensky finally admitted that “many, many hospitals” were counting COVID deaths to include cases that were not COVID deaths.
The Gateway Pundit was right. Trump was right. The tech giants and CNN were wrong again pushing fake news.
But we were the ones who were punished.”
“Many, many hospitals are screening people for COVID when they come in, so not all of those 223 cases who had COVID actually died of COVID. They may have had mild disease, but died, for example, of a heart attack,” CDC Director Rochelle Walensky said on CNN’s “State of the Union” on Sunday.
Under the usual counting program, people who have not been vaccinated but who die of heart attacks or other causes are typically listed as a COVID-19 death.”
Covid excess deaths and other myths destroyed, More US excess deaths in 2017, Covid deaths also exaggerated, Lockdowns and masks questioned, PNAS study
Adolescents 12 to 15 years old need protection from FDA not Covid-19, News release contains lies, Lie 1: “potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks”
“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells
“it is my sincere hope that this public letter might stimulate FDA, Pfizer and Moderna leaders to think critically and quickly about the immunological danger the COVID-19 vaccine might pose to those persons naturally infected by SARS-CoV-2 — most especially to those infected who are recently convalescent, asymptomatic carriers, the elderly and frail or those with significant cardiovascular risk factors.”...Dr. Hooman Noorchashm
“VAERS received 4,434 reports of death (0.0017%) among people who received a COVID-19 vaccine.”...CDC May 11, 2021
From the FDA May 10, 2021.
“Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic
Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
From March 1, 2020 through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder COVID-19 disease course as compared to adults. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.
The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population.
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”
The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The issuance of an EUA is not an FDA approval (licensure) of a vaccine. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance or to protect public health or safety.
FDA Evaluation of Available Safety Data
The available safety data to support the EUA in adolescents down to 12 years of age, include 2,260 participants ages 12 through 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were followed for safety for at least two months following the second dose.
The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. The side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older. It is important to note that as a general matter, while some individuals experience side effects following any vaccination, not every individual’s experience will be the same and some people may not experience side effects.
The Pfizer-BioNTech COVID-19 Vaccine should not be given to anyone with a known history of a severe allergic reaction, including anaphylaxis—to any component of the vaccine. Since its authorization for emergency use, rare severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine in some recipients.
FDA Evaluation of Available Effectiveness Data
The effectiveness data to support the EUA in adolescents down to 12 years of age is based on immunogenicity and an analysis of COVID-19 cases. The immune response to the vaccine in 190 participants, 12 through 15 years of age, was compared to the immune response of 170 participants, 16 through 25 years of age. In this analysis, the immune response of adolescents was non-inferior to (at least as good as) the immune response of the older participants. An analysis of cases of COVID-19 occurring among participants, 12 through 15 years of age, seven days after the second dose was also conducted. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, no cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients; the vaccine was 100% effective in preventing COVID-19. At this time, there are limited data to address whether the vaccine can prevent transmission of the virus from person to person. In addition, at this time, data are not available to determine how long the vaccine will provide protection.
Ongoing Safety Monitoring
As part of the original EUA request, Pfizer Inc. submitted a plan to continue monitoring the safety of the vaccine as it is used under EUA. This plan has been updated to include the newly authorized adolescent population, and includes longer-term safety follow-up for participants enrolled in ongoing clinical trials, as well as other activities aimed at monitoring the safety of the Pfizer-BioNTech COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.
It is mandatory for Pfizer Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System for Pfizer-BioNTech COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death.”
“potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks”
Benefits?
CDC: “most children with COVID-19 have mild or no symptoms”
The FDA study states that 16 out of 978 placebo recipients got Covid. That is 1.6 percent.
The death rate for Covid in this age group is nearly statistically zero.
The known risks are frightening. The unknown perhaps more frightening. (see below)
Lie 2.
“An analysis of cases of COVID-19 occurring among participants, 12 through 15 years of age, seven days after the second dose was also conducted. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, no cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients; the vaccine was 100% effective in preventing COVID-19.”
That does not prove that “the vaccine was 100% effective in preventing COVID-19.”
There is no way to prove that.
And furthermore, only 1.6 percent of placebo recipients getting Covid proves the vaccine is unnecessary.
Misleading statements.
Generally speaking, most of the news release is misleading.
Perhaps the worst offender in this category is the following.
“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
If they had reviewed all of the data the news release should not have happened.
Consider the following:
Just this week a 17 year old was hospitalized with 3 brain blood clots.
CDC reports 4434 deaths “among people who received a COVID-19 vaccine”, Insufficient Informed Consent, Why FDA should not authorize vaccines for children
FDA to authorize Covid vaccine for children ages 12 to 15, Death risk less than .1 percent, “vaccinate the young to protect the old” is evil and stupid, Contact FDA
“Why are we vaccinating healthy adults when 81 percent of Covid-19 cases are mild and there is a 99 percent survival rate. Why are we testing vaccines on children who are minimally impacted by the disease?”…Citizen Wells
“it is my sincere hope that this public letter might stimulate FDA, Pfizer and Moderna leaders to think critically and quickly about the immunological danger the COVID-19 vaccine might pose to those persons naturally infected by SARS-CoV-2 — most especially to those infected who are recently convalescent, asymptomatic carriers, the elderly and frail or those with significant cardiovascular risk factors.”...Dr. Hooman Noorchashm
“We are being lied to on a scale unimaginable by George Orwell.”…Citizen Wells
From The Defender May 4, 2021.
“FDA Set to Authorize Pfizer Vaccine for Adolescents, But Some Experts Question Need, Ethics
The U.S Food and Drug Administration could by early next week expand Pfizer’s Emergency Use Authorization to include children ages 12 to 15, an age group whose risk of dying from COVID is less than 0.1%
The U.S. Food and Drug Administration (FDA) is preparing to authorize use of the Pfizer-BioNTech COVID vaccine in adolescents 12 to 15 years old by early next week, according to federal officials familiar with the agency’s plans. The vaccine is currently authorized in the U.S for emergency use in people 16 and older.
The decision, which is likely to be supported by the Centers for Disease Control and Prevention (CDC), would allow most middle and high school students to get vaccinated before summer camps and the start of the 2021-22 school year, USA TODAY reported.
“A study in the European Journal of Pediatrics confirmed hospitalization and in-hospital death are rare in children diagnosed with COVID, with complications occurring mostly in those with serious underlying medical conditions.”
“Although health officials admit “kids do not generally suffer from severe COVID-19” and are unlikely to directly benefit from the injections, they have no intention of excluding children from their herd immunity calculus. Instead, they claim “inoculating [children] could reduce the spread to people at higher risk.”
In short, public health leaders say, parents must “vaccinate the young to protect the old.”””
Citizen WElls 