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Updated: Aug 8, 2025

Author Spotlight: A Pseudotype Virus System for Assessing Omicron Subvariants and Neutralizing Antibodies in SARS-CoV-2 Research
Published on: September 8, 2023
COVID-19 Vaccine Effectiveness Against Omicron Infection and Hospitalization
Pierre-Philippe Piché-Renaud1,2, Sarah Swayze3, Sarah A Buchan4,5,3,6
1Division of Pediatric Infectious Diseases, The Hospital for Sick Children, Toronto, Ontario, Canada.
Insights
Two doses of the BNT162b2 vaccine offer moderate protection against symptomatic Omicron infections and strong protection against severe outcomes in children aged 5 to 11 years. Longer intervals between doses enhance protection against symptomatic infection, though this benefit diminishes over time.
Area of Science:
- Immunology
- Public Health
- Pediatrics
Background:
- The Omicron variant of SARS-CoV-2 poses a significant threat to public health.
- Vaccine effectiveness (VE) data for pediatric populations against Omicron are crucial for guiding vaccination strategies.
- Real-world evidence is needed to assess the BNT162b2 vaccine's performance in children aged 5 to 11 years.
Purpose of the Study:
- To provide real-world evidence on the effectiveness of the BNT162b2 vaccine against symptomatic infection and severe outcomes caused by the Omicron variant in children aged 5 to 11 years.
- To evaluate the impact of dosing intervals and time since vaccination on vaccine effectiveness.
- To inform public health recommendations for pediatric COVID-19 vaccination.
Main Methods:
- A test-negative study design was employed using linked provincial databases in Ontario.
- Multivariable logistic regression was used to estimate VE against symptomatic infection and severe outcomes.
- Data were collected between January 2 and August 27, 2022, including 6284 test-positive cases and 8389 test-negative controls.
Main Results:
- VE against symptomatic Omicron infection was 24% after one dose and 66% after two doses (7-29 days post-vaccination).
- VE against symptomatic infection was higher with longer dosing intervals (≥56 days: 57%) compared to shorter intervals (15-27 days: 12%).
- VE against severe outcomes was 94% within 7-29 days after two doses, waning to 57% after ≥120 days.
Conclusions:
- Two doses of BNT162b2 provide moderate protection against symptomatic Omicron infection and good protection against severe outcomes in children aged 5 to 11 years.
- Protection against infection wanes more rapidly than protection against severe outcomes.
- Longer dosing intervals enhance initial protection against symptomatic infection, but this advantage decreases over time.
Objectives:
This study aimed to provide real-world evidence on coronavirus disease 2019 vaccine effectiveness (VE) against symptomatic infection and severe outcomes caused by Omicron in children aged 5 to 11 years.
Methods:
We used the test-negative study design and linked provincial databases to estimate BNT162b2 vaccine effectiveness against symptomatic infection and severe outcomes caused by Omicron in children aged 5 to 11 years between January 2 and August 27, 2022 in Ontario. We used multivariable logistic regression to estimate VE by time since the latest dose, compared with unvaccinated children, and we evaluated VE by dosing interval.
Results:
We included 6284 test-positive cases and 8389 test-negative controls. VE against symptomatic infection declined from 24% (95% confidence interval [CI], 8% to 36%) 14 to 29 days after a first dose and 66% (95% CI, 60% to 71%) 7 to 29 days after 2 doses. VE was higher for children with dosing intervals of ≥56 days (57% [95% CI, 51% to 62%]) than 15 to 27 days (12% [95% CI, -11% to 30%]) and 28 to 41 days (38% [95% CI, 28% to 47%]), but appeared to wane over time for all dosing interval groups. VE against severe outcomes was 94% (95% CI, 57% to 99%) 7 to 29 days after 2 doses and declined to 57% (95%CI, -20% to 85%) after ≥120 days.
Conclusions:
In children aged 5 to 11 years, 2 doses of BNT162b2 provide moderate protection against symptomatic Omicron infection within 4 months of vaccination and good protection against severe outcomes. Protection wanes more rapidly for infection than severe outcomes. Overall, longer dosing intervals confer higher protection against symptomatic infection, however protection decreases and becomes similar to shorter dosing interval starting 90 days after vaccination.
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