Pfizer and BioNTech Announce Strong Immune Response from Booster Dose of COVID-19 mRNA Vaccine in Children Aged 5–11

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Recently, Pfizer and BioNTech announced positive results from a Phase 2/3 clinical trial. The trial, conducted in healthy children aged 5-11, is evaluating the safety, tolerability, and immunogenicity of a 10μg booster dose (third dose) of the Pfizer-BioNTech COVID-19 mRNA vaccine.

Data show that compared to two doses, a booster dose (third dose) increases neutralizing titers against the SARS-CoV-2 Omicron variant and wild-type strains. These data reinforce the potential efficacy of a third vaccine dose in maintaining high levels of viral protection in this age group (children aged 5-11).

This Phase 2/3 clinical trial analyzed data from 140 children aged 5-11 who received a booster dose (third dose) approximately six months after completing the second dose of the Pfizer-BioNTech COVID-19 mRNA vaccine primary series (10 μg).

A sub-analysis of 30 serum samples in the study showed that, in this age group, the serum antibodies induced by the third dose of the vaccine could neutralize the SARS-CoV-2 Omicron variant. Compared with the data observed after two doses of the Pfizer-BioNTech COVID-19 mRNA vaccine, the neutralizing antibody titer increased 36-fold. A strong immune response was observed regardless of prior SARS-CoV-2 infection.

Moreover, immunogenicity data from 140 children without any prior evidence of SARS-CoV-2 infection showed that one month after receiving the booster dose, the geometric mean titer (GMT) of neutralizing antibodies against the wild-type SARS-CoV-2 strain increased 6-fold compared to the GMT one month after the second dose, indicating a strong immune response in this age group.

To date, more than 10,000 children under the age of 12 have participated in the Pfizer-BioNTech COVID-19 mRNA vaccine clinical trials. In the latest booster data results (n=401), the vaccine was well tolerated, with no new safety signals observed.

Pfizer and BioNTech Plan to Submit Emergency Use Authorization (EUA) Application to the U.S. FDA in the Coming Days for Pfizer-BioNTech COVID-19 mRNA Vaccine Booster for Children Aged 5-11. Meanwhile, the Two Companies Also Plan to Share These Data with the European Medicines Agency (EMA) and Other Regulatory Authorities as Soon as Possible.

Reference Source: Pfizer and BioNTech Announce Data Demonstrating High Immune Response Following a Booster Dose of their COVID-19 Vaccine in Children 5 Through 11 Years of Age