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?”
Dishonest CDC director Walensky continues to misrepresent Covid impact on adolescents in June 4, 2021 media release, Why doesn’t she urge obese youth to lose weight and exercise?
“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
Dishonest CDC director Walensky recently admitted that Covid hospitalization data was inflated and that approx only 5 percent of that number was strictly from Covid-19 and not other ailments or conditions.
Now she is misrepresenting data again in an effort to brainwash the public into thinking that adolescents must be vaccinated to remain safe.
“Statement from CDC Director Rochelle P. Walensky, MD, MPH
Media Statement
For Immediate Release: Friday, June 4, 2021″
“On May 12, 2021, CDC recommended use of the Pfizer COVID-19 vaccine in people aged 12 years and up based on the safety and efficacy of the vaccine in adolescents following clinical trials. At the time, there was a growing body of evidence that demonstrated the severe health impacts of COVID-19 on adolescents.
Today’s MMWR presents additional data reporting the trends in hospitalizations among adolescents with COVID-19. I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation.
Much of this suffering can be prevented.
Until they are fully vaccinated, adolescents should continue to wear masks and take precautions when around others who are not vaccinated to protect themselves, and their family, friends, and community. I ask parents, relatives and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated. If parents or their teenagers have questions or concerns, I suggest they talk with their adolescent’s healthcare provider, local health department or neighborhood pharmacist.”
Hospitalization of Adolescents Aged 12–17 Years with Laboratory-Confirmed COVID-19 — COVID-NET, 14 States, March 1, 2020–April 24, 2021
Early Release / June 4, 2021
“Among 376 adolescents hospitalized during January 1–March 31, 2021, who received a positive SARS-CoV-2 laboratory test result, 172 (45.7%) were analyzed separately because their primary reason for admission might not have been directly COVID-19–related (Table). Among the 204 patients who were likely admitted primarily for COVID-19–related illness, 52.5% were female, 31.4% were Hispanic or Latino (Hispanic), and 35.8% were non-Hispanic Black. Overall, 70.6% had one or more underlying medical conditions, the most common of which were obesity (35.8%), chronic lung disease, including asthma (30.9%), and neurologic disorders (14.2%); 31.4% of patients required ICU admission and 4.9% required invasive mechanical ventilation, but there were no associated deaths.”
“The findings in this report are subject to at least five limitations. First, the primary reason for hospital admission was not always clear, and some (45.7%) adolescents who met the COVID-NET case definition were hospitalized for reasons that might not have been primarily related to COVID-19, despite a positive SARS-CoV-2 laboratory test result; these hospitalizations were included in rate calculations. Thus, rates of hospitalizations for COVID-19 might be overestimated.”
The most common underlying medical condition was obesity.
Why doesn’t CDC director Walensky urge adolescents and other segments to lose weight, to exercise and diet, instead of pushing an experimental vaccine?
5165 deaths reported after Covid vaccinations 23359 serious injuries from VAERS reports, 628 cases of myocarditis and pericarditis, Latest research: spike protein travels in blood from injection site
“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 4, 2021.
“Latest VAERS Data Show: 5,165 Deaths Reported Following COVID Vaccines
VAERS data released today showed 294,801 reports of adverse events following COVID vaccines, including 5,165 deaths and 25,359 serious injuries between Dec. 14, 2020 and May 28, 2021.”
4,740 total adverse events, including 117 rated as serious and four reported deaths among 12 to 17-year-olds. The youngest deaths reported include two 15-year-olds (VAERS I.D. 1187918 and 1242573), a 16-year-old (VAERS I.D. 1225942) and one 17-year-old (VAERS I.D. 1199455). There were other reported deaths in children under 17 that could not be confirmed or contained obvious errors.
635 reports of anaphylaxis among 12- to17-year-olds with 97% of cases attributed to Pfizer’s vaccine, 2% to Moderna and 0.31% (or two cases) to J&J.
40 reports of myocarditis and pericarditis (heart inflammation) all attributed to Pfizer’s COVID vaccine.
Of the 2,876 cases of Bell’s Palsy reported, 52% were reported after Pfizer vaccinations, 41% following vaccination with the Moderna vaccine and 253 cases, or 9%, of Bell’s Palsy cases were reported in conjunction with J&J.
Seven cases of heart inflammation reported in teen boys, new study shows
On June 4, The Defender reported seven boys between the ages of 14 and 19 in the U.S. reportedly developed chest pain and heart inflammation within four days of receiving a second dose of the Pfizer vaccine, according to a study published today in Pediatrics.
Heart imaging tests detected a rare type of heart muscle inflammation called myocarditis and pericarditis. None of the teens were critically ill but all were hospitalized.”
“‘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 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.””
Moderna press release straight out of “1984”, “TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint”, Kids need protection from big Pharma not Covid-19
“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 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
“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 Moderna May 25, 2021.
“Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Phase 2/3 study of its COVID-19 vaccine (mRNA-1273) in adolescents has met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition. In addition, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose using the secondary CDC case definition of COVID-19, which tested for milder disease. This study, known as the TeenCOVE study, enrolled more than 3,700 participants ages 12 to less than 18 years in the U.S. The Company plans to submit these data to regulators globally in early June.
“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”
In this Phase 2/3 study, 3,732 adolescent participants ages 12 to less than 18 years were enrolled and randomized 2:1 to two 100 µg doses of mRNA-1273 or placebo. The primary endpoint of non-inferior immunogenicity versus the Phase 3 adult study comparator group was met. After two doses, no cases of COVID-19 were observed in the vaccine group using the case definition from the adult Phase 3 COVE study, compared to 4 cases in the placebo group, resulting in a vaccine efficacy of 100% starting 14 days after the second dose. Because the incidence rate of COVID-19 is lower in adolescents, a secondary case definition based on the CDC definition of COVID-19 was also evaluated to include cases presenting with milder symptoms. Using the CDC definition, which requires only one COVID-19 symptom and a nasopharyngeal (NP) swab or saliva sample positive for SARS-CoV-2 by RT-PCR, a vaccine efficacy of 93% after the first dose was observed.
mRNA-1273 was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults. No significant safety concerns have been identified to date. The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills.
Safety data continues to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. Consequently, these data are subject to change based on ongoing data collection. The Company plans to submit data from the TeenCOVE study to a peer-reviewed publication.”
First of all, kids do not need protection from Covid-19, they need protection from big Pharma and the government.
Dr. Mike Yeadon, former vice president of Pfizer:
“Because COVID vaccines use experimental technology that may pose serious side effects such as blood clots, Yeadon said, “we should absolutely not be offering them to young, healthy people who are not at risk from the virus.””
“I have two healthy adult girls, 25 and 29 years-old, and I would be really upset if they ended up being coerced into taking these products because they’re healthy and young, and there are not any measurable risks from COVID-19.”
Secondly they tout a 93 percent efficacy rate.
The placebo group in a FDA report from May 10, 2021 had a better rate than that.
“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)”
8 month old baby youngest Covid Vaccine test subject, Vincenzo (Enzo) Mincolla received 2 doses of Pfizer vaccine, Why would anyone allow their baby to be experiment subject where risks outweigh gains?
“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 road to hell is paved with good intentions”...Karl Marx quoting Martin Luther
Fact: There is a near zero statistical chance of a 8 month old baby dying of Covid-19.
A recent test by Pfizer on 12 to 15 year olds receiving placebos revealed that only 1.6 percent of the subjects even caught Covid.
FDA: “Children and adolescents generally have a milder COVID-19 disease course as compared to adults.”
Recent data from the CDC revealed that 4,434 people have died after receiving the vaccine and many thousands injured.
The risk vs benefit rule would indicate that 8 month old babies should not be vaccinated with an experimental vaccine.
So why would parents allow this to happen?
From MSN.
“Baby Becomes World’s Youngest Person to Get 2 Pfizer COVID-19 Vaccine Doses
A baby involved in clinical trials into the effects of COVID vaccinations among children has reportedly become the youngest person in the world to get two Pfizer jabs against the disease.”
“Mike and Marissa Mincolla, both doctors from Baldwinsville, New York, said they had no qualms about their eight-month-old son, Vincenzo, or “Enzo” being administered with two doses of the vaccine at Upstate Medical University.
“We both feel it’s important to end this pandemic, and the quickest and safest way is to vaccinate our way out of it,” Mike Mincolla said, according to Syracuse.com.
Enzo is among 16 babies involved in phase one of trials at four sites in the U.S. into the effects of the Pfizer vaccine on children under five.”
“”I tell them, ‘I feel so comfortable with this vaccine I gave it to my seven-month-old child,'” he said. “It’s safe, effective and it works.” The couple has enrolled their four-year-old daughter for the trial. “We are helping science and evidence-based medicine,” he added.”
CDC FDA NIAID half of employees vaccinated, Senator Burr question to Dr. Fauci Dr. Marks Dr. Walensky, They ok experiments and use on children and not fully embracing Covid vaccines
“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 a recent Senate hearing.
Senator Burr: “Okay, this question I’m gonna go to Dr. Fauci, Dr. Marks, and Dr. Walensky,”
“What percentage of employees in your institute, your center, or your agency, of your employees, has been vaccinated?”
Dr. Fauci: “You know, I’m not a hundred percent sure, senator, but I think it’s probably a little bit more than half, probably around sixty percent”
Dr. Marks: “I can’t tell you the exact number, but it’s probably in the same range, some people vaccinated at our facility, and others at, uh, outside of the facility”
Dr. Walensky: “We’re encouraging our employees to get vaccinated, we’ve been doing town halls and education seminars we have our staff have the option to report their vaccination status but it’s you, understand the federal government is not requiring it so we do not know”
Senator Burr asked Fauci, Peter Marks from the FDA, and @CDCDirector what percentage of their own employees are vaccinated.
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
Citizen WElls 