The following article is from the Children’s Health Defense
On May 10, 2021, the U.S. Food and Drug Administration (FDA) extended its emergency use authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine to adolescents 12 through 15 years of age, amending the EUA (issued December 11, 2020) that authorized the injection for individuals age 16 and up. Moderna has indicated that it plans to request similar EUA expansion to 12-17 year-olds for its COVID vaccine, and Johnson & Johnson/Janssen is conducting clinical trials in that age group.
In giving its green light to Pfizer, the FDA chose to ignore the following facts, all of which make it abundantly clear that vaccinating children and adolescents against COVID-19 is both medically indefensible and unethical.
American children are at negligible risk1 for COVID-19. As of May 29, 2021, the Centers for Disease Control and Prevention (CDC) attributed 366 deaths in children aged 0-18 to COVID,2 out of a child population of 74 million—a mortality rate of 0.00049%. As a cause of death for children aged 1-17, COVID-19 ranks behind injury, suicide, cancer, homicide, congenital anomalies, heart disease, influenza, chronic lower respiratory disease and cerebrovascular causes.1 From February 2020 through mid-February 2021, 29,094 children (aged 0-14) and 36,900 adolescents and young adults (aged 15-24) died from causes other than COVID-19.3 Children’s risk of developing serious COVID illness is minuscule, as evidenced by the CDC’s use of 5-17 year-olds as its reference group (the group with the lowest risk) when describing risks of COVID infection, hospitalization and death for other age groups.4 Informed doctors argue that “not even a handful of children should be endangered through mass vaccination against a disease that is not dangerous to them.”5
COVID vaccines are experimental. As the FDA plainly states in its COVID vaccine fact sheets, vaccines administered under EUA status are not FDA-approved and have “not undergone the same type of review as an FDA-approved or cleared product.”6,7
COVID injections rely on experimental vaccine technologies;8 problematic ingredients such as polyethylene glycol (PEG)9 and polysorbate 80;10 lipid nanoparticles readily taken up by the brain;11 and other unproven vaccine science. Moreover, though acting FDA head Janet Woodcock assured parents “that the agency undertook a rigorous and thorough review of all available data,”12 no studies have been done on toxicity, carcinogenicity, fetal and reproductive risks or other important aspects of safety.13
Experimental COVID vaccines are far more dangerous to children than the disease. Prior to the EUA expansion to 12-15 year-olds, the Vaccine Adverse Event Reporting System (VAERS) showed two deaths in 15-year-olds who had each received a Pfizer or Moderna vaccine. These adolescents may have been enrolled in clinical trials, as they could not otherwise have received the vaccines legally at the time. With about 1,000 adolescents 12-15 years old in Pfizer’s clinical trial vaccine group—and about the same number in Moderna’s trial—the death rate following either vaccination in this age group may be approximately 0.1% (two in 2,000)—over 200 times higher than the COVID-19 mortality rate.
Adolescents are reporting serious COVID vaccine injuries, including cardiac problems and deaths. COVID vaccine injury reports for the 12-17 age group almost quadrupled from May 14 to May 21, going from 943 to 3,449 adverse events—including 58 injuries rated as serious.14
The next week, the COVID vaccine injury total for that age group jumped by another 37% to 4,750,15 comprising 209 serious injuries and five deaths attributed to cardiac arrest.16,17 A study published in June in Pediatrics documented seven teens hospitalized for heart inflammation within four days of receiving their second Pfizer shots.18 Adolescents are also experiencing blood clots and Guillain-Barré syndrome.19,20 A 17-year-old Utah athlete developed blood clots in his brain one day after receiving his first Pfizer injection.21
Long-term adverse effects from COVID vaccines, including reproductive effects, “cannot be ruled out.” Doctors are warning about the possibility of “long-term adverse effects that have not yet been discovered at this time, including on growth, reproductive system or fertility.”5 Already, worrisome reproductive effects have been documented following Pfizer and Moderna vaccination. A CDC study in the New England Journal of Medicine showed that 12.7% of COVID-vaccinated pregnant women lost their babies to miscarriage or stillbirth (almost one in eight women).22 In addition, 99 of 724 live-born babies (13.7%) had adverse birth outcomes such as preterm birth, small size for gestational age or “major congenital anomalies.” Conversely, there is no evidence to suggest that children need to be worried about the long-term effects of COVID-19 illness.1 For children and teenagers who have their lives ahead of them, the COVID vaccines’ potential ramifications for future fertility are troubling, especially given that “it could take a relatively long time before a noticeable number of cases of post-vaccination infertility could be observed.”23
Children who receive COVID shots will face an additional risk that most adults will not: simultaneous administration of multiple vaccines. According to Pfizer, there is “no information on the co-administration of the Pfizer-BioNTech COVID-19 vaccine with other vaccines.”6 CDC, too, admits that it does not know whether reactogenicity (the body’s inflammatory response to vaccination) increases with vaccine co-administration.24 Nonetheless, CDC is allowing healthcare providers to administer COVID vaccines and other childhood and adolescent vaccines “without regard to timing.”25 Considering the CDC vaccine schedule for adolescents, this means that a 12-year-old could conceivably receive an experimental COVID shot on the same day as the influenza, human papillomavirus (HPV), meningococcal and Tdap (tetanus-diphtheria-pertussis) vaccines.26 If FDA expands its EUA to still-younger age groups, children could be loaded up with even more injections during a single doctor’s visit, particularly if doctors push “catch-up” vaccination because of missed appointments during the pandemic.27 Package inserts for licensed childhood and adolescent vaccines already list nearly 400 possible adverse events, including death.28 The Institute of Medicine has warned that systematic research on “key elements of the entire [childhood vaccine] schedule—the number, frequency, timing, order, and age at administration of vaccines”—has never been done,29 an opinion shared (albeit reluctantly) by global vaccine experts at a World Health Organization (WHO) meeting in December 2019.30
Government officials have indicated that they are willing to trample on parental rights and ability to protect children. About half of parents responding to an April poll stated that they either “definitely” would not be getting their child COVID-vaccinated or planned to wait and see; another 18% would allow the vaccine only if schools require it.31 To circumvent the hurdle of obtaining consent from parents,32 a growing number of states and jurisdictions are purporting to give healthcare providers and medical practices leeway to dispense with parental consent requirements for COVID vaccines,33 despite the injections’ investigational status.34
Promising children and adolescents a return to “normalcy” is coercive. FDA Commissioner Janet Woodcock, CDC director Rochelle Walensky and Pfizer CEO Albert Bourla have promised youngsters that COVID vaccination is their ticket to a renewed “sense of normalcy” and a “faster return to social activities.”12, 41, 42 These pledges are enticing socially starved teens—who are developmentally incapable of fairly weighing risks and benefits—to badger their parents about getting the injections or even to look into getting a vaccine without their parents’ permission.40, 43 Six hundred thousand 12- to 15-year-olds got COVID jabs within the first week of the EUA expansion.44
Vaccine manufacturers are overpromising what their COVID injections can do—for both adults and children. The COVID vaccines were not designed to block coronavirus transmission.45 Thus, the vaccines’ reported “effectiveness” pertains only to the injections’ ability to lessen symptom severity.46 Moreover, effectiveness cannot be meaningfully understood unless one grasps the major distinction between relative and absolute risk.47 Reporting only relative risk, Pfizer declared its injection “100% effective” for 12- to 15-year-olds42 on the basis of trials with 2,260 younger adolescents and 18 cases of COVID-19 in the placebo group (versus zero in the vaccine group).48 These numbers equate to a “teensy-tiny” reduction in absolute risk49 of 1.59% (18 divided by 1,129 teens in the placebo group). When researchers do not report absolute risk reduction, “reporting bias is introduced, which affects the interpretation of vaccine efficacy”50—raising questions about the investigators’ intent and integrity. Parents should also bear in mind that Pfizer, according to independent analysis, doctored its clinical trial effectiveness results for adults by excluding thousands of participants who had symptoms identical to COVID but not confirmed by PCR testing.51 Access to “full datasets and independent scrutiny and analyses”50 are needed to assess whether similar sleight of hand might have produced the magic “100% effective” result for adolescents.
COVID vaccines in 2021 are just the beginning. Most parents and teens are not recognizing that accepting one to two COVID injections now will not be the end of the story. COVID booster shots are already in the offing—introducing the prospect of recurrent and cumulative risks.52 As parents familiar with the already burdensome childhood vaccine schedule can attest, vaccine requirements for children only ever seem to go in one direction—UP—while the status of children’s health continues on its alarming downhill trajectory.53
- What do you do when the kids are still unvaccinated? The New York Times, Apr. 22, 2021..
- Centers for Disease Control and Prevention (CDC). Provisional COVID-19 deaths: focus on ages 0-18 years. Updated June 2, 2021..
- The Heritage Foundation. COVID-19 deaths by age. Updated Feb. 17, 2021..
- CDC. Risk for COVID-19 infection, hospitalization, and death by age group. Updated Feb. 18, 2021..
- 93 Israeli doctors: Do not use COVID-19 vaccine on children. Arutz Sheva, Apr. 11, 2021..
- Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19)..
- Fact sheet for recipients and caregivers: Emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) in individuals 12 years of age and older..
- Children’s Health Defense. COVID-19: The spearpoint for rolling out a “new era” of of high-risk, genetically engineered vaccines. May 7, 2020..
- Redwood L. 5 questions Fauci and FDA need to answer on Pfizer and Moderna COVID vaccines. The Defender, Dec. 23, 2020. .
- Children’s Health Defense. These “inactive” ingredients in COVID vaccines could trigger allergic reactions. The Defender, Mar. 12, 2021. .
- Shankar R, Joshi M, Pathak K. Lipid nanoparticles: A novel approach for brain targeting. Pharm Nanotechnol. 2018;6(2):81-93.
- Food and Drug Administration (FDA). Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic. News release, May 10, 2021. .
- Children’s Health Defense. What we know — and may never know — about COVID vaccines. The Defender, May 14, 2021..
- Redshaw M. COVID vaccine injury reports among 12- to 17-year-olds more than triple in 1 week, VAERS data show. The Defender, May 28, 2021.
- MedAlerts: Found 9,459 cases where Age is 6-or-more-and-under-18 and Vaccine is COVID19.
- MedAlerts: Found 274 cases where Age is 6-or-more-and-under-18 and Vaccine is COVID19 and Serious.
- MedAlerts: Found 274 cases where Age is 6-or-more-and-under-18 and Vaccine is COVID19 and Serious.
- Redshaw M. 7 U.S. teens developed heart inflammation after second Pfizer vaccine, new study shows. The Defender, June 4, 2021.
- Redshaw M. 18-year-old undergoes 3 brain surgeries from blood clots after J&J vaccine. The Defender, Apr. 21, 2021.
- Redshaw M. Teen diagnosed with Guillain-Barré weeks after first COVID vaccine. The Defender, Apr. 6, 2021.
- Redshaw M. Teen hospitalized with blood clots in brain after first dose of Pfizer vaccine. The Defender, May 10, 2021.
- Shimabukuro TT, Kim SY, Myers TR, et al. Preliminary findings of mRNA COVID-19 vaccine safety in pregnant persons. N Engl J Med. 2021 Apr 21;NEJMoa2104983.
- Petition/motion for administrative/regulatory action regarding confirmation of efficacy end points and use of data in connection with the following clinical trial(s)…
- Pagliarulo N. CDC panel endorses Pfizer vaccine for 12- to 15-year-olds. BioPharma Dive, May 12, 2021.
- Woodworth K. Clinical considerations for Pfizer-BioNTech COVID-19 vaccination in adolescents. CDC, May 12, 2021.
- Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2021.
- Howard J, Mascarenhas L. Doctors urge parents to catch kids up on other shots ahead of COVID-19 vaccine rollout. CNN, May 10, 2021.
- Children’s Health Defense. Read the fine print, part two—nearly 400 adverse reactions listed in vaccine package inserts. Aug. 14, 2020.
- Institute of Medicine. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press, 2013.
- Children’s Health Defense. Look WHO’s talking! Vaccine scientists confirm major safety problems. Jan. 16, 2020.
- Hamel L, Lopes L, Sparks G, et al. KFF COVID-19 vaccine monitor – April 2021. Kaiser Family Foundation, May 6, 2021.
- Tishler CL, Reiss NS. Pediatric drug-trial recruitment: Enticement without coercion. Pediatrics. 2011;127(5):949-954.
- Howard J, Langmaid V. Most states require parental consent for COVID-19 shots for ages 12 to 15, but not all. Here’s the list. CNN, May 18, 2021..
- Emergency Use Authorization (EUA) for an Unapproved Product: Review Memorandum.
- Hazlehurst R. Urgent: D.C. parents, take action to protect children from being vaccinated without parental consent. The Defender, May 11, 2021.
- COVID-19 Vaccine Provider Guidance.
- 2013 Code of Alabama Title 22 – HEALTH, MENTAL HEALTH, AND ENVIRONMENTAL CONTROL. Title 1 – HEALTH AND ENVIRONMENTAL CONTROL GENERALLY. Section 22-8-4 – When minor may give consent generally..
- Oregon Health Authority: Minor Consent Statement.
- Tennessee Department of Health: Mature Minor Doctrine.
- Terlep S. COVID-19 shots for teens can hit legal snags and parental pushback. The Wall Street Journal, May 19, 2021.
- CDC. CDC director statement on Pfizer’s use of COVID-19 vaccine in adolescents age 12 and older. Media statement, May 12, 2021.
- Branswell H. FDA authorizes Pfizer’s COVID-19 vaccine for use in adolescents. STAT, May 10, 2021.
- Larsen K. “We’re all ready”: Many Bay Area 12-15 year-olds eager for Pfizer’s COVID vaccine after FDA EUA. ABC, May 13, 2021.
- Mendez R. CDC says 600,000 kids ages 12 to 15 have received COVID vaccine shots in last week. CNBC, May 18, 2021.
- Mayer A. Leading COVID vaccine candidates plagued by safety concerns. The Defender, Nov. 13, 2020..
- Doshi P. Will COVID-19 vaccines save lives? Current trials aren’t designed to tell us. BMJ. 2020;371:m4037.
- Children’s Health Defense. Vaccine makers claim COVID shots are “95% effective” — but what does that mean? The Defender, May 5, 2021.
- Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents. Press release, Mar. 31, 2021.
- Rogers A. The statistical secrets of COVID-19 vaccines. WIRED, May 6, 2021.
- Olliaro P, Torreele E, Vaillant M. COVID-19 vaccine efficacy and effectiveness—the elephant (not) in the room. Lancet Microbe, 2021 Apr 20.
- Doshi P. Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data. BMJ Opinion, Jan. 4, 2021. .
- Langmaid V, Vera A. COVID-19 booster shot will likely be needed within a year of vaccination, Fauci says. CNN, May 19, 2021.
- Children’s Health Defense. Facts about children’s health.