On June 15, 2022 the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) unanimously advised the FDA staff to grant Moderna and Pfizer/BioNTech an Emergency Use Authorization (EUA) amendment to allow their mRNA COVID vaccines to be given to children under age five and as young as six months.1 2 3 Within 48 hours, the FDA approved the EUA amendment followed by a June 17-18 meeting of the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) that ended with a unanimous recommendation for both COVID vaccines to be given to all children in the six-month to five-year-old age group, which was immediately approved by the CDC’s director.4 5
National rollout of the reduced dose vaccines is underway this week and, with it, the U.S. becomes the first country to give COVID vaccine to children under age two.6
Natural immunity from SARS-CoV-2 infection has been documented to be robust and long lasting,7 8 9 and the CDC estimated in April that about 75 percent of children ages 0 to 11 years old in the U.S. already had been infected.10 After the CDC admitted in March that pediatric deaths from COVID were initially over-estimated,11 a June 15 FDA briefing document stated that, “According to death certificate data, 202 deaths have been attributed to COVID-19 among children 6 months to 4 years of age through May 11, 2022.”12
The FDA briefing document confirmed that “many persons” with COVID are “presenting with asymptomatic or mild disease,” noting that symptoms in children are “generally milder” and as many as 50 percent of infections in children are asymptomatic. The agency said that about half of the children four years old or younger, who were hospitalized with COVID, had one or more underlying health conditions.13
Weak mRNA COVID Vaccine Efficacy for Young Children
FDA summary documents for both Moderna and Pfizer vaccines show weak efficacy, especially when considering that the FDA did not require COVID-19 vaccine manufacturers to demonstrate their vaccines prevent infection and transmission of the SARS-CoV-2 virus to obtain an EUA.14 The companies were only required to demonstrate a minimum 50 percent efficacy in preventing severe COVID disease leading to hospitalization and death before the FDA granted an EUA to both companies in December 2020.
As the SARS-CoV-2 virus has evolved and created different variants over the past two years, COVID disease has been reported in a growing number of vaccinated people with quickly waning immunity, who are able to transmit the virus to others even though they are vaccinated.15 16 On June 15, 2022, the Washington State Department of Health reported that, between Jan. 17, 2021 and June 4, 2022, over 500,000 reported COVID cases occurred in vaccinated persons in that state, with 17 percent of vaccinated persons reporting symptoms, two percent being hospitalized and 0.4 percent dying of COVID-related illness.17
The clinical trial data from Pfizer and Moderna that the FDA used to green light administering mRNA COVID vaccines to very young children revealed that the efficacy of two 25 microgram doses (one quarter of the adult dose) of the Moderna COVID vaccine given about a month apart to children six months to five years old, who had not been previously infected with SARS-CoV-2, was 50.6 percent in preventing symptomatic COVID-19 in a six to 23 month old age group and 36.8 percent effective in a two to five year old age group. The Pfizer COVID vaccine, which is given in three doses containing three micrograms (one tenth the adult dose) with three weeks between the first and second dose and two months between the second and third dose, was tested in children aged six months to five years old. Although Pfizer reported 80 percent efficacy after the third dose in children under five, the numbers of children evaluated were so tiny that the FDA staff simply commented in its June 15 briefing paper for VRBPAC that, “In these FDA analyses, the immune response to the vaccine for both age groups of children was comparable to the immune response of the older participants.”18
mRNA COVID Vaccines for Young Children: Safety Last
Knowing that the mRNA COVID vaccines do not reliably prevent infection and transmission of the SARS-CoV-2 virus, and that efficacy in preventing symptomatic COVID disease is marginal at best, have Pfizer, Moderna and the FDA and CDC demonstrated that it is safe to give mRNA COVID vaccines to all babies as young as six months old?
According to the public statement issued by the FDA last week, there is a gap between what is known and is not known about mRNA COVID vaccine safety in young children:
The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.19
The key words are “the known and potential risks.” There is lack of clarity and transparency on that point and one reason is because the release of this vaccine for babies as young as six months old is based on an EUA, not full licensure. This is the first vaccine to be recommended for and administered to babies in the U.S. on a mass basis that has not been fully licensed.
The June 18 public statement issued by the CDC did not contain any language about risk and only stated that,”COVID-19 vaccines have undergone—and will continue to undergo—the most intensive safety monitoring in U.S. history.” The CDC Director told doctors and parents that, “All children, including children who have already had COVID-19, should get vaccinated,”20 a policy that was immediately endorsed by the American Academy of Pediatrics (AAP).21 She gave that order even though the majority of babies and young children in America have already acquired natural immunity from prior infections, and even though the majority of children enrolled in the Moderna and Pfizer COVID vaccine clinical trials had not been previously infected with SARS-CoV-2. This means that the potential risks of giving mRNA COVID vaccines to babies and young children with a history of prior SARS-COV-2 infection (many asymptomatic) are unknown.
In 2013, an Institute of Medicine (IOM) committee confirmed that the safety of the CDC recommended childhood vaccine schedule from birth to age six has not been fully scientifically evaluated.22 In the report The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies,23 the committee stated, “key elements of the entire schedule – the number, frequency, timing, order and age at administration of vaccines – have not been systematically evaluated in research studies.” The IOM committee also warned that:
… evidence assessing outcomes in subpopulations of children, who may be potentially susceptible to adverse reactions to vaccines (such as children with a family history of autoimmune disease or allergies or children born prematurely) is limited and is characterized by uncertainty about the definition of populations of interest and definition of exposures or outcomes. Most children who experience an adverse reaction to immunization have a preexisting susceptibility. Some predispositions may be detectable prior to vaccination; others, at least with current technology and practice, are not.
Nothing appears to have changed in the past decade. On June 18, the ACIP Committee told doctors to give mRNA COVID vaccines at the same time with other CDC recommended childhood vaccines. Already, a six-month old baby can receive nine vaccines and a 15- month old toddler can receive 11 CDC recommended vaccines on the same day.24
Where is the science evaluating the potential risks of adding a COVID shot to that mix?
Following is a June 15 response by Doran Fink, MD, PhD, Acting Deputy Director of FDA Office Vaccines Research & Review to a question from a VRBPAC temporary voting member about co-administration of COVID vaccines with other vaccines that he asked in light of the fact that pediatricians see “enhanced fever and even febrile seizures with co-administration of other vaccines together that all cause fever.” Dr. Fink’s reply confirmed that Moderna and Pfizer have not produced safety data regarding co-administration of their COVID vaccines to six-month old babies and young children: 25
We have routinely requested co-administration studies in [unintelligble] applications of vaccines that are intended for the very young infants, those who are younger than six months of age, because the immunization schedule is so compressed and it is difficult to avoid co-administration. We have not routinely requested or required co-administration studies for older children, but we have always encouraged that the manufacturers study safety and evaluate interference of co-administration when introducing a new vaccine into the pediatric schedule. We do expect that studies will be done going forward.
mRNA COVID Vaccines Are Very Reactive
Pfizer, Moderna and federal health agencies have published information that both mRNA COVID vaccines are generally very reactive, with the majority of adults and older children experiencing local and systemic reactions within seven days of vaccination that can require a two to three day recovery period.26 27 28 There are multiple articles in the medical literature documenting that mRNA COVID vaccines cause a very strong inflammatory response in the majority of people vaccinated, which is manifested by a range of symptoms, including fever, chills, injection site pain, fatigue, headache, and body aching.29
Yet, the adverse reaction charts from clinical studies presented last week at the FDA and CDC advisory committee meetings for children under age five, especially for babies, suggest that there is little difference between the vaccinated and saline placebo groups for many commonly reported adverse events following the low dose Pfizer COVID vaccine, such as fever, irritability/crying, decreased appetite, drowsiness, headache, chills, diarrhea, and joint pain, with the exception that more reactions were reported after the second dose just like in older children and adults.30 The Moderna vaccine, which uses a higher pediatric dose, more often showed a bigger difference between commonly reported reactions in the vaccinated and placebo groups.31
But the dominant take-home message of the COVID vaccine clinical trial adverse reaction charts for younger children is that a whole lot of babies and toddlers are having fevers, chills, fatigue, irritability, headache and body pain even if they don’t receive the COVID vaccine. In some charts, the companies claim that the placebo group had more adverse events reported than the vaccinated group.
Whether the charts are accurate or not, the bottom line is that parents who choose to give their young children the Pfizer or Moderna mRNA COVID vaccine should monitor for any unusual physical, mental or emotional symptoms after vaccination. Parents know their children best and should not assume that health deterioration after COVID vaccinations has no relationship with the vaccine recently given, especially since increased reactions were noted for both vaccines after second doses. Vaccine adverse event symptoms that were looked at in the pre-EUA studies included high fever; irritability/crying; excessive sleepiness; pain, redness and swelling at injection site; refusal to eat; trouble breathing, rapid heart rate and chest pain (myocarditis); swollen lymph nodes; muscle aches; vomiting and diarrhea; trembling or jerking of the limbs (seizure) and respiratory infections following vaccination, all of which should be recorded in the child’s medical record.
More severe reactions, including hospitalizations, injuries and deaths, should be reported to the Vaccine Adverse Event Reporting System (VAERS). Since 1990, more than 2.1 million adverse events for all vaccines have been reported to VAERS by June 10, 2022, with more than 1.2 million of those adverse events associated with either the Pfizer or Moderna mRNA COVID vaccines.32
Long Term Effects of mRNA COVID Vaccines Unknown
In addition to being the first vaccine to be fast tracked under an EUA rather than full licensure and given to millions of infants and young children in the U.S., mRNA COVID vaccine is also the first one to use an mRNA technology that has remained experimental until now. For example, Pfizer spent just 248 days testing their mRNA 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.”33 34 To speed up the COVID vaccine testing process, FDA allowed Pfizer and other drug companies to conduct some of the animal and human clinical studies simultaneously, instead of sequentially.35 To further accelerate approval, FDA also allowed companies to provide testing data from previous research on other types of experimental mRNA vaccines as preliminary proof that COVID mRNA vaccines were effective and safe, even though those other mRNA vaccines were never licensed.36
Two years before Pfizer and Moderna got an EUA to distribute their mRNA vaccines, academic researchers warned of potential safety issues with the platform, like local and systemic inflammation; stimulation of hyper-inflammatory immune responses causing chronic inflammation and autoimmunity; and the presence of extracellular RNA that may cause edema and the formation of blood clots.37 This is the first human vaccine to include lipid nanoparticles, which coat the synthetic mRNA in COVID vaccines and are highly inflammatory.38 There are questions about bio-distribution and a debate about whether those nanoparticles can accumulate in different organs of the body like the liver, spleen, lungs, kidneys and perhaps crosses the blood brain barrier, or end up in the ovaries and potentially affect fertility.39
Myocarditis and pericarditis (inflammation of the heart) have been reported after both Pfizer and Moderna mRNA COVID vaccines, occurring most frequently in adolescent and young adult males and after the second dose.40 Other severe adverse events reported in the medical literature include anaphylaxis and blood and immune mediated neurological disorders like Guillain Barre Syndrome (GBS).41 The data evaluating these more serious adverse events in infants and young children is too limited to know how many children will exhibit signs of immune and brain dysfunction after receiving mRNA COVID vaccines.
During the public comment period of the day-long June 15 VRBPAC meeting, which can be viewed on YouTube,42 most of the comments were made by mothers expressing fear and anger about the delay in making COVID vaccine available for their young children, which they have kept house-bound and masked children for two years. However, there were a few comments that opposed the EUA amendment, including Texas Congressman and attorney Louis Gohmert (at 5:07) who said, “There are many unanswered questions regarding the safety and efficacy of COVID vaccines, especially for babies and young children, and I am deeply concerned that the push to vaccinate these children is nothing more than a dystopian experiment with unknown consequences.” Sobbing through her testimony, mother Shae Lynn (at 5:16) described how an mRNA COVID vaccine reaction ruined her life, with doctors dismissing her symptoms and ignoring her pleas for help. Expertly schooling the committee on what the FDA knew about the risks of mRNA vaccines but “did nothing” about, Sam Dodson (at 5:27) declared, “You have abjectly failed in your sole duty to ensure the safety of any drug given to Americans.”
78 Percent of Americans Have Gotten COVID Shots But Parents of Young Children Are Hesitant
By June 17, 2022, about 78 percent of Americans over age five had been given COVID vaccinations,43 with about 222 million of them “fully vaccinated” according to the CDC and about 121 million having received one or two booster shots.44 The CDC said the new COVID vaccine recommendation for babies as young as six months old will open up the market to about 20 million more children, but the agency noted that only about 29 percent of children ages five to 11 have been vaccinated since the Pfizer mRNA COVID vaccine was approved for that age group in November 2021.45
An April 2022 poll revealed that four in 10 parents with children under age five are hesitant to give their young children COVID vaccine with 27 percent saying they will “definitely not” vaccinate their children and 11 percent indicating they will only do it if it is mandated.46
If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.
Click here to view References:
1 U.S. Food and Drug Administration. Vaccines & Related Biological Products Advisory Committee Meeting: Information and Event Materials. June 15, 2022.
2 Tanner L, Stobbe M. FDA advisers endorse 1st COVID-19 shots for kids under 5. Associated Press June 15, 2022.
3 FDA. Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age. June 17, 2022.
4 U.S. Centers for Disease Control & Prevention. Advisory Committee on Immunization Practices (ACIP) Meeting: ACIP Presentation Slides. June 17, 2022.
5 CDC. CDC Recommends COVID-19 Vaccines for Young Children. June 18, 2022.
6 Michelson A, deGraaf M. The 7 countries where kids under 5 years old are eligible for COVID-19 vaccines, and how the roll-outs are shaping up. Business Insider Apr. 15, 2022.
7 Kojima N, Klausner JD. Protective immunity after recovery from SARS-CoV-2 Infection. The Lancet 2021; 22(1): 12-14.
8 Altarwneh HN, Hasan MR, Ayoub HH et al. Protection against the Omicron Variant from Previous SARS-CoV-2 Infection. N Engl J Med Feb. 9, 2022.
9 Balachandran H, Phetsouphanh C et al. Maintenance of broad neutralizing antibodies and memory B cells 1 year post-infection is predicted by SARS-CoV-2 specific CD4+ T cell responses. Cell Rep 2022; 38(6).
10 CDC. Seroprevalence of Infection-Induced SARS-CoV-2 Antibodies – United States, September 2021 – February 2022. MMWR Apr. 29 2022; 71(17): 606-608.
11 Reuters. CDC reports fewer COVID-19 pediatric deaths after data correction. Mar. 18 2022.
12 FDA. Briefing Document on EUA amendment request for Pfizer-BioNTech COVID-19 vaccine for use in children 6 months through 4 years of age. VRBPAC Meeting June 15, 2022.
14 FDA. Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry. Efficacy Considerations Pages 13-24. Revised June 2020.
15 Stiepan DD. COVID-19 infections among vaccinated people: What you need to know. Mayo Clinic Aug. 5, 2021.
16 Ferdinands JM, Rao , Dixon BE et al. Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance – VISION Network, 10 States, Aug MMWR Feb. 11, 2022; 71.
17 Washington State Department of Health. SARS-CoV-2 Vaccine Breakthrough Surveillance and Case Information Resource. June 15, 2022.
18 FDA. Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age. June 17, 2022.
20 CDC. CDC Recommends COVID-19 Vaccines for Young Children. June 18, 2022.
21 American Academy of Pediatrics. COVID-19 Vaccine: Frequently Asked Questions: Which COVID-19 vaccine should I recommend to my patients? June 17, 2022.
22 National Vaccine Information Center. National Vaccine Information Center Supports Three of Five Recommendations of New IOM Report on U.S. Childhood Immunization Schedule Safety and Calls for Transparency. Jan. 16, 2013.
23 Institute of Medicine Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. Conclusions About Scientific Findings (p. 11) and Summary of Scientific Findings (p. 130). The Childhood Immunization Schedule and Safety Stakeholder Concerns, Scientific Evidence and Future Studies; Washington, D.C. The National Academies Press 2013.
24 CDC. Recommended Child and Adolescent Immunization Schedule
for ages 18 years or younger – United States, 2022. Feb. 17, 2022.
25 YouTube. Virtual Meeting: Vaccines & Related Biological Products Advisory Committee Wednesday, June 15, 2022. (At 5:54)
26 CDC. What to Expect After Getting a COVID-19 Vaccine. Mar. 9, 2021.
27 CDC. Pfizer/BioNTech COVID-19 Vaccine Reactions and Adverse Events. Nov. 5, 2021.
28 CDC. Moderna COVID-19 Vaccine’s Local Reactions, Systemic Reactions, Adverse Events and Serious Adverse Events. Aug. 9, 2021.
29 Fisher BL. What Mothers Should Know About COVID and COVID-19 Vaccines. National Vaccine Information Center Mar. 7, 2022.
30 FDA. Briefing Document on EUA amendment request for Pfizer-BioNTech COVID-19 vaccine for use in children 6 months through 4 years of age. (p. 41-48. VRBPAC Meeting June 15, 2022.
31 FDA. Briefing Document on EUA amendment request for use of the Moderna COVID-19 vaccine for us in children 6 months through 17 years of age. (p. 157-164) VRBPAC Meeting June 14-15, 2022.
32 MedAlerts.org. Search the U.S. Government’s VAERS Data. June 10, 2022.
33 Doxzen K, Prichep E. mRNA vaccines – here’s everything you need to know. World Economic Forum July 1, 2021.
34 Petri W. COVID-19 vaccines were developed in record time – but are these game-changers safe? The Conversation Nov. 20, 2020.
35 FDA. Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry. Efficacy Considerations Pages 13-24. Revised June 2020.
36 Bell P. The lightning-fast quest for COVID vaccines – and what it means for other diseases. Nature Dec. 18, 2020.
37 Pardi N, Hogan MJ, Porter FW, Weissman D. mRNA vaccines – a new era in vaccinology. Nature Reviews Drug Discovery 2018 (17): 261-279.
38 Dwivedi R. Research looks at inflammatory nature of lipid nanoparticle component in mRNA vaccines. News-Medical.net May 15, 2021.
39 Yong SJ. Biodistribution and Spike Protein Safety of mRNA Vaccines: An Update. Medium July 7, 2021.
40 CDC. Myocarditis and Pericarditis after mRNA COVID-19 Vaccination. June 19, 2022.
41 Finsterer J. Neurological side effects of SARS-CoV-2 vaccinations. Acta Neurol Scand 2022; 145(1): 509.
42 YouTube. Virtual Meeting: Vaccines & Related Biological Products Advisory Committee Wednesday, June 15, 2022.
43 Our World in Data. Share of people vaccinated against COVID-19 by June 17, 2022: United States.
44 CDC. COVID Data Tracker: COVID-19 Vaccinations in the United States. June 17, 2022.
45 CDC. CDC Recommends COVID-19 Vaccines for Young Children. June 18, 2022.
46 Kaiser Family Foundation. KFF COVID-19 Vaccine Monitor: April 2022. May 4, 2022.