Vaccine Effectiveness against Omicron- Pediatric and Adolescent Patients- Primary Series of monovalent BNT162b2 Vaccine

Page last reviewed 12 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 pediatric and adolescents in Real World Evidence (RWE) studies. ^(1-14) These studies have noted the benefit of vaccination against confirmed ^{(1, 4, 11, 12)} and symptomatic ^{(4, 9)} COVID-19 infection and more severe outcomes, such as Emergency Department (ED)/Urgent Care (UC) visits ^{(2, 14)}, hospitalization ⁽³⁾, and hospitalization or death ^(11-13) in children and adolescents.

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 and/or death, have been studied in recipients of 2 doses of BNT162b2 (reference group: unvaccinated), in periods of Omicron (B.1.1.529) predominance.VE% (95% CI) against the following outcomes at the listed times post last vaccine dose, has been reported:^{(1-4, 9, 11-14)}

Table Data

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Confirmed infection

*Confirmed infection = positive SARS-CoV-2 PCR

Ages 5-11 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]	Ages 12-15 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]	Ages 12-18 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]
≥ 7 days: 65 (62-68) ⁽¹²⁾ ≥ 14 days: 45 (44-45) ⁽¹¹⁾ 7-21 days: 51 (39-61) ⁽⁴⁾ 14–82 days: 31 (9–48) ⁽¹⁾ 30-59 days: 60 (54-66) ⁽¹²⁾	≥14 days: 59 (24–78) ⁽¹⁾	Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology

Symptomatic infection

Ages 5-11 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]	Ages 12-15 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]	Ages 12-18 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]
7-21 days: 48 (29-63)⁽⁴⁾ 14–30 days: 60 (55–65)⁽⁹⁾	14–30 days: 60 (44–71)⁽⁹⁾	Ages 12-17, 14-27 days: 65 (63-66) ^(13),a Ages 12-17, 14-27 days: 83 (81-85) ^(13),b

ED/UC visits

Ages 5-11 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]	Ages 12-15 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]	Ages 12-18 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]
14–67 days: 51 (30–65)⁽²⁾	14–149 days: 45 (30–57)⁽²⁾	Ages 12-17, <2 months: 73 (54-84)⁽¹⁴⁾ Ages 12-17, ≥ 6 months: 16 (-7-34)⁽¹⁴⁾ Ages 16–17, 14–149 days: 34 (8–53)⁽²⁾

Hospitalization

Ages 5-11 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]	Ages 12-15 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]	Ages 12-18 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]
≥ 7 days: 83 (75-88) ⁽¹²⁾ ≥ 14 days: 68 (42–82) ⁽³⁾ 30-59 days: 80 (67-88) ⁽¹²⁾	Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology	Ages 12–18, ≥ 14 days: 40 (9–60)⁽³⁾

Hospitalization or death

Ages 5-11 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]	Ages 12-15 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]	Ages 12-18 years VE% (95% CI) of 2 doses of BNT162b2 [Reference: Unvaccinated]
≥ 14 days: 55 (41-66) ⁽¹¹⁾	Not reported in studies meeting this website’s inclusion criteria- please refer to Methodology	Ages 12-17, 14-27 days: 76 (58-86) ^(13),c Ages 12-17, ≥ 98 days: 83 (69-90) ^(13),c

Footnotes

a= study values reported in Brazil; b= study values reported in Scotland; c= the hospitalization and death analysis was restricted to Brazil due to the small number of cases 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, at the listed times post last vaccine dose has been reported: