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Bivalent Omicron BA.4/BA.5 BNT162b2 Vaccine in 6-Month- to <12-Year-Olds
Lawrence D Sher1, Justice K Boakye-Appiah2, Sungeen Hill2
1Peninsula Research Associates, Rolling Hills Estates, California, USA.
Insights
A fourth dose of the bivalent BNT162b2 vaccine in children aged 6 months to 11 years demonstrated strong immune responses against SARS-CoV-2 variants. The COVID-19 vaccine showed a favorable safety profile, supporting its use in pediatric populations.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Infectious Diseases
Background:
- The ongoing evolution of SARS-CoV-2 necessitates continuous evaluation of vaccine effectiveness in all age groups.
- Pediatric vaccination is crucial for controlling COVID-19 transmission and protecting vulnerable populations.
- Variant-adapted vaccines are being developed to address emerging SARS-CoV-2 strains.
Purpose of the Study:
- To assess the safety and immunogenicity of a fourth dose of a bivalent BNT162b2 vaccine in children aged 6 months to <12 years.
- To compare the immune response to the bivalent vaccine against ancestral and Omicron BA.4/BA.5 strains with previous vaccination regimens.
- To evaluate the reactogenicity and safety profile of the bivalent vaccine in pediatric participants.
Main Methods:
- An open-label substudy of a phase 1/2/3 master study (NCT05543616) involving children aged 6 months to <12 years.
- Participants received a fourth dose of bivalent BNT162b2 vaccine after three doses of the original monovalent BNT162b2 vaccine.
- Immunogenicity was assessed by measuring neutralizing antibody titers and seroresponse rates against SARS-CoV-2 strains.
- Safety and reactogenicity were monitored throughout the study.
Main Results:
- The bivalent BNT162b2 vaccine met predefined immunogenicity criteria for superiority and noninferiority against Omicron BA.4/BA.5 and ancestral strains in children aged 6 months to <5 years.
- In children aged 5 to <12 years, the bivalent vaccine induced robust neutralizing antibody titers comparable to the original vaccine.
- The safety profile of the fourth dose of the bivalent vaccine was consistent with the original vaccine, with generally mild to moderate reactogenicity.
Conclusions:
- The variant-adapted bivalent BNT162b2 vaccine demonstrates a favorable benefit-risk profile for children under 12 years old.
- These findings support the use of updated COVID-19 vaccines in pediatric populations to maintain protection against circulating SARS-CoV-2 variants.
- Continued monitoring of vaccine performance in diverse age groups is essential.
Background:
With the future epidemiology and evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uncertain, the use of safe and effective coronavirus disease 2019 (COVID-19) vaccines in pediatric populations remains important.
Methods:
We report data from two open-label substudies of an ongoing phase 1/2/3 master study (NCT05543616) investigating the safety and immunogenicity of a variant-adapted bivalent COVID-19 vaccine encoding ancestral and Omicron BA.4/BA.5 spike proteins (bivalent BNT162b2). The open-label groups presented here evaluate dose 4 with bivalent BNT162b2 in 6-month- to <12-year-olds who previously received three original (monovalent) BNT162b2 doses. In 6-month- to <5-year-olds, primary immunogenicity objectives were to demonstrate superiority (neutralizing titer) and noninferiority (seroresponse rate) to Omicron BA.4/BA.5 and noninferiority (neutralizing titer and seroresponse rate) to SARS-CoV-2 ancestral strains in participants who received bivalent BNT162b2 dose 4 compared with a matched group who received three doses of original BNT162b2 in the pivotal pediatric study (NCT04816643). In 5- to <12-year-olds, primary immunogenicity comparisons were descriptive. Reactogenicity and safety following vaccination were evaluated.
Results:
In 6-month- to <5-year-olds, dose 4 with bivalent BNT162b2 met predefined immunogenicity superiority and noninferiority criteria against Omicron BA.4/BA.5 and ancestral strains when compared with dose 3 of original BNT162b2. In 5- to <12-year-olds, bivalent BNT162b2 induced robust Omicron BA.4/BA.5 and ancestral strain neutralizing titers comparable with dose 3 of original BNT162b2. The safety profile for dose 4 of bivalent BNT162b2 given as dose 4 was consistent with that of original BNT162b2 in 6-month- to <12-year-olds. Reactogenicity events were generally mild to moderate. No adverse events led to discontinuation.
Conclusions:
These safety and immunogenicity data support a favorable benefit-risk profile for a variant-adapted BNT162b2 in children <12 years old.
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