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BioNTech/Pfizer mRNA Vaccine Booster Shows High Level of Immune Response in Children 5-11 Years Old
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BioNTech/Pfizer mRNA Vaccine Booster Shows High Level of Immune Response in Children 5-11 Years Old.
Recently, Pfizer and BioNTech announced positive results from a Phase 2/3 clinical trial. The trial is evaluating the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 mRNA vaccine 10μg booster (third dose) in healthy children aged 5-11 years.
The data showed that neutralizing titers against SARS-CoV-2 Omicron variant and wild-type strains increased after one booster dose (third dose) compared to two doses. These data reinforce the potential efficacy of the third dose of vaccine in maintaining high levels of viral protection in this age group (5-11 years) of children.
The Phase 2/3 clinical trial analyzed data from 140 children aged 5-11 years. The children received a booster (third dose) approximately 6 months after the second dose of the 10 μg primary immunization schedule of the Pfizer-BioNTech COVID-19 mRNA vaccine.
The results of a sub-analysis of 30 sera from the study showed that, in this age group, the third dose of vaccine-induced serum antibodies, which neutralized the SARS-CoV-2 Omicron variant strain, was comparable to vaccination with 2 doses of Pfizer- Neutralizing antibody titers increased 36-fold compared to the data observed following the BioNTech COVID-19 mRNA vaccine. Robust immune responses were observed regardless of prior infection with SARS-CoV-2.
In addition, immunogenicity data from 140 children without any evidence of precursor SARS-CoV-2 infection showed that compared with SARS-CoV-2 neutralizing geometric mean titers (GMT) one month after the second dose , a 6-fold increase in SARS-CoV-2 wild-type strain-neutralizing GMT one month after booster vaccination, indicating a robust 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 trial, and in the most recent booster data results (n=401), the vaccine was well tolerated and no observed New safety signal.
Pfizer and BioNTech plan to file an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration in the next few days for a booster shot of the Pfizer-BioNTech COVID-19 mRNA vaccine for children ages 5-11. The parties also plan to share these data with the European Medicines Agency (EMA) and other regulators as soon as possible.
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
(source:internet, reference only)