Disclaimer: this discussion focuses on COVID-19 vaccines that are currently authorized for use in the United States as of the publishing date of this article. A number of other COVID-19 vaccines have obtained authorization for use in other countries that are not currently authorized in the United States.
In the United States, there are currently two vaccines authorized by Emergency Use Authorization (EUA) to help prevent COVID-19: the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) and the Moderna COVID-19 vaccine (mRNA-1273).
Although there are other COVID-19 vaccine candidates being studied, these two vaccines are currently the only vaccines authorized for use in the United States.
The Pfizer-BioNTech COVID-19 vaccine is indicated for use in individuals greater than or equal to 16 years of age. The Moderna COVID-19 vaccine is indicated for use in individuals greater than or equal to 18 years of age.
For information about how COVID-19 itself impacts children differently than adults, it is recommended to always first reference Centers for Disease Control and Prevention (CDC) resources. The CDC continues to serve as the gold standard for information related to the ongoing COVID-19 pandemic.
Nonetheless, these current minimum age requirements suggest several different questions. Why do the current COVID-19 vaccines authorized for use in the United States exclude individuals who are 15 years of age and younger? What should individuals 15 years of age and younger do regarding vaccination against COVID-19? Are there any other vaccines being studied that may be utilized in the future for these pediatric patients?
The following discussion will help to answer these important and relevant questions.
The Short Version
The Pfizer-BioNTech COVID-19 vaccine was initially studied in clinical trials only in individuals that were as young as 16 years of age. Thus, it was authorized for emergency use by the United States Food and Drug Administration (FDA) in this demographic group because there was no data available regarding individuals 15 years of age and younger. The same is true for the Moderna COVID-19 vaccine but in regard to individuals as young as 18 years of age.
As of the publishing time of this article, individuals that are 15 years of age and younger should not receive a COVID-19 vaccine. Individuals that are 16 or 17 years of age should only receive the Pfizer-BioNTech vaccine and not the Moderna COVID-19 vaccine.
If an individual younger than the minimum age requirement for either COVID-19 vaccine receives a vaccine against current FDA and CDC recommendations, a report should be submitted to the Vaccine Adverse Event Reporting System (VAERS). This report can be submitted by the patient, a caregiver, or a healthcare provider.
There are multiple other COVID-19 vaccine candidates being studied; but, there is a lack of vaccine candidates assessing patients below the current approved age range. However, the 2 currently-authorized COVID-19 vaccines are both now enrolling patients as young as 12 years of age in ongoing trials to collect safety and efficacy (effectiveness) data. For more information, please reference Table 1 below.
As of right now, there is no clear timeline as to when children and adolescents less than 16 years of age may have access to a COVID-19 vaccine. At this time, COVID-19 vaccination should be deferred for these young patients.
The Long Version
In order for a vaccine to be approved for use by the FDA, it must have data supporting its safety and efficacy in the population subject to assessment in clinical trials. It is common practice to first conduct clinical trials in an adult population between 18 and 65 years of age. Once safety and efficacy data are established in this age range, then additional studies can be conducted in effort to establish safety and efficacy in patient populations older or younger than this stated age range.
The Pfizer-BioNTech COVID-19 vaccine was initially studied in clinical trials only in individuals as young as 16 years of age. Thus, it was authorized for emergency use by the FDA only in this demographic population because there was no data available regarding individuals 15 years of age or younger. The same is true for the Moderna COVID-19 vaccine but in regard to individuals as young as 18 years of age.
The Pfizer-BioNTech COVID-19 vaccine was the first COVID-19 vaccine authorized for use in the United States. Before the Pfizer-BioNTech COVID-19 vaccine was given EUA status, there was initial discussion by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) that it should only be used in patients greater than or equal to 18 years of age rather than 16 years of age. However, the panel of experts that comprise VRBPAC voted 17-4-1 to support the favorable risk-benefit profile of the Pfizer-BioNTech vaccine in individuals as young as 16 years of age.
Although patients as young as 16 years of age were included in studies conducted during the development process of the Pfizer-BioNTech COVID-19 vaccine, there were initial concerns about the data in patients that were 16 or 17 years old (mostly due to low enrollment numbers in trial participants of that age category). Preferably, well-supported and reliable data in general will be backed by a large sample (participant) size. This was a main pillar of the VRBPAC debate.
For background, VRBPAC is an organization separate from the FDA that “reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility”, according to the FDA. The FDA considers input from VRBPAC while making a decision on if it should authorize a vaccine candidate for use in the United States.
This same dilemma was not discussed for the Moderna COVID-19 vaccine. The clinical trials conducted for Moderna’s then-vaccine candidate included individuals only above the age of 18 years, so there was not a concern regarding potentially insufficient numbers in patients that were 16 or 17 years of age.
However, for both of these vaccines, data are now being collected in individuals as young as 12 years of age.
As of the publishing time of this article, individuals that are 15 years of age or younger should not receive a COVID-19 vaccine. Individuals that are 16 or 17 years of age should only receive the Pfizer-BioNTech vaccine and not the Moderna COVID-19 vaccine.
However, there are multiple COVID-19 vaccine candidates being studied and the currently-authorized COVID-19 vaccines also have additional clinical trials underway to compile data for additional patient demographics.
None of the vaccine candidates not already approved in the United States are collecting data for individuals that are below the age of 16 years. However, Pfizer-BioNTech is now enrolling patients in its clinical trials that are between 12 and 15 years of age. Similarly, Moderna is running a clinical trial which includes patients between 12 and 17 and of age. For more information, please reference Table 1 below.
Of note, Table 1 is not an all-inclusive list of COVID-19 vaccines. As of 17 January 2021, 68 different COVID-19 vaccine candidates are being assessed in clinical trials. Of these, three large-scale phase III clinical trials are being conducted in the United States for additional vaccine candidates. These are the COVID-19 vaccine candidates produced by AstraZeneca, Janssen, and Novavax.
Table 1. Minimum Age Considerations for Select COVID-19 Vaccines & Vaccine Candidates (as of 17 January 2021)
| Vaccine | Current Status | Minimum Age Being Studied in Clinical Trial(s) |
| Pfizer-BioNTech (BNT162b2) | Authorized via EUA | Currently approved for 16 years of age and older Now also being studied in individuals 12-15 years of age |
| Moderna (mRNA-1273) | Authorized via EUA | Currently approved for 18 years of age and older Additional studies being performed in individuals 12-17 years of age |
| AstraZeneca (AZD1222) | Phase 3 | 18 years of age |
| Johnson & Johnson/Janssen (Ad26.COV2.S) | Phase 3 | 18 years of age |
| Novavax (NVX-CoV2373) | Phase 3 | 18 years of age |
As data are being collected in individuals who are as young as 12 years of age, there is promise on the horizon that the FDA’s EUA for the Pfizer-BioNTech and Moderna COVID-19 vaccines, respectively, may eventually be extended to include patients as young as 12 years of age. More information will be released about this in the coming weeks and months as data is collected, made available, and analyzed.
Currently, no data is being compiled from studies for individuals that are 11 years of age or younger. Thus, it is unclear if/when individuals of this age group will be eligible to receive a vaccine for COVID-19.
Yet, regardless of age, all adults and children should continue to maintain proper hand hygiene, wear a mask when interacting with others or when in close proximity with others, follow quarantine protocols, and socially distance as much as possible.
If you are a caregiver and your child has symptoms of COVID-19 or you think they might have COVID-19, please call your child’s healthcare provider. Keep your child at home and away from others as much as possible except to get medical care. If possible, have your child use a separate bedroom and bathroom from other family members. Follow recommendations from the CDC, the World Health Organization (WHO), and your state government’s guidance regarding quarantine and isolation measures as appropriate.
If an individual below the minimum age requirement for either COVID-19 vaccine receives a vaccine against current FDA and CDC recommendations, a report should be submitted to the Vaccine Adverse Event Reporting System (VAERS). This report can be submitted by either the patient or the healthcare provider that administered the vaccination.
References:
- Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States. Centers for Disease Control and Prevention (CDC). Last updated 6 January 2021. Accessed 17 January 2021. Accessible via: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
- 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). United States Food and Drug Administration (FDA). Revised 6 January 2021. Accessed 17 January 2021. Accessible via: https://www.fda.gov/media/144413/download
- Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Accessible via: https://pubmed.ncbi.nlm.nih.gov/33301246/
- Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) | Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). United States Food and Drug Administration (FDA). Revised December 2020. Accessed 17 January 2021. Accessible via: https://www.fda.gov/media/144637/download
- Baden LR, El Sahly HM, Essink B, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2020 Dec 30. doi: 10.1056/NEJMoa2035389. Accessible via: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7787219/
- Zimmer C, Corum J, Wee SL. Coronavirus Vaccine Tracker. The New York Times. Last updated 14 January 2021. Accessed 17 January 2021. Accessible via: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#jnj
- NCT04649151: A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19 (TeenCove). ClinicalTrials.gov. Last update posted 14 January 2021. Accessed 17 January 2021. Accessible via: https://clinicaltrials.gov/ct2/show/NCT04649151?term=12+years&cond=Moderna&draw=2&rank=1
- Aubrey A. Will Kids Get A COVID-19 Vaccine? Pfizer To Expand Trial To Ages 12 And Up? NPR. Published 13 October 2020. Accessed 17 January 2021. Accessible via: https://www.npr.org/sections/health-shots/2020/10/13/923248377/will-kids-get-a-covid-19-vaccine-pfizer-to-expand-trial-to-ages-12-and-up
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