On October 29, 2021, the Food and Drug Administration (FDA) granted an emergency use authorization for administering the Pfizer-BioNTech COVID-19 Vaccine to children as young as five (5) and up to eleven (11) years old. [i] This gives over 28 million children in the USA the opportunity to get immunized, in addition to the previous authorization granted for 26 million children aged 12 to 17 years old. [ii]
As a result, most people in the United States aged five years and older now qualify for a COVID-19 vaccine. However, for those aged 5 to 17, only the Pfizer-BioNTech COVID-19 Vaccine is approved so far, whereas for those 18 years and older, the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines are available.
Is there a need to vaccinate children under the age of 12?
COVID-19 has a milder effect on some kids. However, severe symptoms and death are still part of the varus’s effects on children aged 5 to 11 years old. Pediatric cases of COVID-19 have risen by about 240 percent in the United States. [iii]. The CDC has recorded 8,300 COVID-19 hospitalizations and 146 deaths among children 5 to 11 years old [iv]. Some experience severe lung infections or multisystem inflammatory syndrome with long-lasting symptoms. [v]
What do the case studies show?
The FDA emergency use authorization relies on Pfizer-BioNTech’s trial findings still in progress in children 5 to 11 years of age. Pfizer-BioNTech announced the Phase 2 trial results on September 20, 2021. Participants were given smaller doses of two 10 µg 21 days apart. The smaller dose is in comparison to the 30 µg doses administered for ages 12 and up. According to the press release, “the antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses.” [vi]
There are 2,268 participants from 5 to 11 years old, each receiving the 10 µg doses 21 days apart. The geometric mean titer (GMT) for this group was 1,197.6, equating to a 95% confidence interval displaying a similar robust immune response as seen in the control group participants aged 16 to 25 years old. This control group was given two doses of 30 µg, 21 days apart, and had a GMT of 1,146.5, which was also at a 95% confidence interval. Side effects observed from both groups were similar and generally comparable.
What do the case studies show?
Recent polls are showing up to 57% of U.S. parents are planning to get their children aged 5 to 11 given the Pfizer-BioNTech vaccine. Interestingly, this polling estimate is very close to the percentage of the U.S. population that is fully vaccinated, which is 58.1%. [vii]
6 Talking Points for Health Professionals Speaking to Parents about COVID-19 Vaccines
“Are children under age 12 susceptible to COVID-19?”
Children under the age of 12 are susceptible to catching COVID-19. Generally, the symptoms may be milder than experienced by an adult, but not always. Over 8,300 kids aged 5 to 11 have been hospitalized due to COVID-19. The hospitalizations have increased since the outbreak of the Delta variant.
“Why should my child get vaccinated?”
Just as in adolescents and adults, those fully vaccinated are much less likely to contract COVID-19. However, if they do contract COVID-19, the symptoms will be much less severe, and the risk of hospitalization and death is also significantly reduced, just as with fully vaccinated adults. Being vaccinated also reduces the likelihood of spreading COVID-19 and may allow your child and your family to start doing things outside the home with better protection.
“What vaccines are available for kids under 12?”
Currently, the FDA has only granted the Pfizer-BioNTech vaccine an emergency use authorization for administration to children aged 5 to 11 years old.
“What are the side effects?”
The possible side effects are similar to those experienced by those 12 years and older. The most common side effects are pain around the injection point, fatigue, chills, headache, muscle pain, fever, and joint pain. These side effects typically last 1 to 3 days. Many have reported no side effects. Side effects can be treated with over-the-counter pain relievers once experienced. [viii]
“Can the vaccine give my kid COVID-19?”
No. All the COVID-19 vaccines in the U.S., including the Pfizer-BioNTech vaccine, do not contain the live virus that causes COVID-19.
“How long must my kid wait before getting other vaccines after receiving the COVID-19 vaccine?”
The COVID-19 vaccine can be given on the same day as other vaccines your child may need. The CDC recently changed its guidance on this after allowing enough safety data to be gathered.
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REFERENCES & RESOURCES
- Commissioner, O. of the (2021). FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age. [online] FDA. Available at: https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age.
- datacenter.kidscount.org. (n.d.). Child population by age group | KIDS COUNT Data Center. [online] Available at: https://datacenter.kidscount.org/data/tables/101-child-population-by-age-group#detailed/1/any/false/574.
- Pfizer.com. (2021). Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years | Pfizer. [online] Available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results.
- Commissioner, O. of the (2021). FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age. [online] FDA. Available at: https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age.
- www.hopkinsmedicine.org. (n.d.). COVID-19 Vaccine: What Parents Need to Know. [online] Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/covid19-vaccine-what-parents-need-to-know.
- Pfizer.com. (2021). Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years | Pfizer. [online] Available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results.
- www.google.com. (n.d.). how many americans are covid-19 vaccinated%3F – Google Search. [online] Available at: https://www.google.com/search?q=how+many+americans+are+covid-19+vaccinated%3F&rlz=1C1RXQR_enUS971US972&oq=how+many+americans+are+covid-19+vaccinated%3F&aqs=chrome..69i57.11754j0j15&sourceid=chrome&ie=UTF-8 [Accessed 5 Nov. 2021].
- Mayo Clinic. (n.d.). COVID-19 vaccines for kids: What you need to know. [online] Available at: https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/covid-19-vaccines-for-kids/art-20513332.
By: Erik McLaughlin MD, MPH and Aikaterini Papadopoulou, B.Arch
