Vaccine Effectiveness against Pre-Omicron variants- Pediatric and Adolescent Patients- Primary Series of monovalent BNT162b2 Vaccine
Page last reviewed 13 February 2023
Key Points
Key Points are meant to be a scientific, factual summary of the available information that relates solely to the Pfizer-BioNTech COVID-19 Vaccine, as supported by referenced publications within this section. Conclusions should not be drawn from the inclusion or absence of information.
- Vaccine effectiveness (VE) of monovalent BNT162b2 has been studied in Real World Evidence (RWE) studies.(1-14) These studies have assessed VE against infection and more severe outcomes, such as hospitalization, ICU admission and Emergency Department (ED) and Urgent Care (UC) visits in children and adolescents.(1-14)
Outcomes
RWE on VE against several outcomes of interest has varied across studies, and these cannot be compared due to differences in study design and methodology.
- Outcomes of interest, such as confirmed infection, symptomatic infection, ED/UC visits and hospitalization, have been reported in recipients of 1 and 2 doses of monovalent BNT162b2 (reference group: unvaccinated), in periods of Delta (B.1.617.2) predominance.VE% (95% CI) against the following outcomes at the listed times post last vaccine dose, has been reported:(1-3, 5-8, 10,13,14)
Table Data
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Confirmed infection
| Ages 12-17 years VE%(95%CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-15 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-18 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|---|
| Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | ≥14 days: 81 (51–93) (1) | Ages 12-17, ≥ 14 days: 63 (64-67) (10) to 92 (79–97) (6) Ages 12-18: ≥ 14 days:90 (79–95) (7) 7–21 days: 90 (88–92) (8) |
Symptomatic infection
| Ages 12-17 years VE%(95%CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-15 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-18 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|---|
| ≥ 14 days: 52 (51-54)(13) to 55 (53-57)(13) | Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | Ages 12-17, 14-27 days: 81 (78-83)(13),ato 93 (86-96)(13),b Ages 12-17, 56-69 days: 27 (4-44)(13),ato 87 (72-93)(13),b Ages 12-18, ≥ 14 days: 93 (81–97)(7) Ages 12-18, 7–21 days: 93 (88–97)(8) |
ED/UC visits
| Ages 12-17 years VE%(95%CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-15 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-18 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|---|
| Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | 14–149 days: 92 (89–94) (2) |
Ages 12-17, < 2 months: 89 (69-96)(14) Ages 12-17, ≥ 6 months: 49 (27-65)(14) Ages 16–17, 14–149 days: 85 (81–89)(2) |
Hospitalization
| Ages 12-17 years VE%(95%CI) of 1 dose of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-15 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-18 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|---|
| Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | ≥ 14 days:95 (88–97) (5) | Ages 12–18, ≥ 14 days: 92 (89–95)(3) to 94 (90–96)(5) Ages 16-18, ≥ 14 days: 94 (88–97) (5) |
Footnotes
a=value reported in study population in Brazil; b=value reported in study population in Scotland
Waning VE
- RWE has also highlighted waning VE over time following last dose of vaccine, in recipients of 2 doses of monovalent BNT162b2 (reference group: unvaccinated). VE% (95% CI) against the following outcomes, during a period of Delta (B.1.617.2) predominance, at the listed times post last vaccine dose, has been reported(1,2,7,13,14):
Table Data
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Confirmed infection
| Ages 12-15 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 16-17 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-18 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|---|
| ≥ 14 days: 81 (51–93)(1) 14–149 days: 87 (49–97)(1) ≥ 150 days: 60 (-35–88) (1) |
Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | 1–4 weeks: 91 (33–99) (7) 13–17 weeks: 83 (34–95) (7) |
Symptomatic infection
| Ages 12-15 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 16-17 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-18 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|---|
| Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology | Ages 12-17, 14-27 days: 81 (78-83)(13),ato 93 (86-96)(13),b Ages 12-17,56-69 days: 27 (4-44)(13),ato 87 (72-93)(13),b |
ED/UC visits
| Ages 12-15 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 16-17 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
Ages 12-18 years VE%(95%CI) of 2 doses of BNT162b2, at listed times post last vaccine dose [Reference: Unvaccinated] |
|---|---|---|
| 14–149 days: 92 (89–94)(2) ≥ 150 days: 79 (68–86)(2) |
14–149 days: 85 (81–89)(2) ≥ 150 days: 77 (67–84)(2) |
Ages 12-17, < 2 months: 89 (69-96)(14) Ages 12-17, ≥ 6 months: 49 (27-65)(14) |
Footnotes
a=value reported in study population in Brazil; b=value reported in study population in Scotland
- In general, lower VE rates were observed for confirmed infection and ED/UC visits with longer time past receipt of last dose of BNT162b2, in the pediatric and adolescent populations in the studies included in this summary.(1-3, 7, 13, 14)
References: (1) Fowlkes, (2) Klein, (3) Price, (4) Cohen-Stavi, (5) Olson, (6) Lutrick, (7) Oliveira, (8) Reis, (9) Fleming-Dutra, (10) Husin, (11) Sacco, (12) Tan NEJM 2022, (13) Florentino, (14) Tartof JAMA Netw Open
Publications have reported different definitions of COVID-19 outcomes. Definitions can be found under Primary Endpoints and Definitions for each study below.
