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On September 20, local time, Pfizer and BioNTech announced the results of a Phase 2/3 clinical trial of the mRNA vaccine BNT162b2 in children aged 5-11
.
In children of this age, the vaccine shows good safety and a strong neutralizing antibody response
It is reported that this study is part of a phase 1/2/3 clinical trial, involving 4,500 children aged 6 months to 11 years in more than 90 clinical trial sites in the United States, Finland, Poland and Spain
.
Specifically, the two companies hope to understand the effectiveness of the vaccine in children aged 5 to 11 years, 2 to 5 years old, and 6 months to 2 years old
This Phase 2/3 study included 2,268 children between 5 and 11 years old, of which 1/3 were the control group and received a placebo injection of saline; the other 2/3 were included in the vaccine group, with an interval of three weeks Two doses of 10 µg vaccine were given
.
According to Pfizer's official website, the 10 µg dose has been carefully selected as the preferred dose for safety, tolerability and immunogenicity in children aged 5 to 11 years
.
Although this dose is 1/3 of the 30 µg dose for adults, the antibody response induced in children aged 5-11 is comparable to the antibody response recorded in the population vaccinated between 16 and 25 years of age
The data shows that one month after the completion of two doses of vaccination, the SARS-CoV-2 neutralizing antibody geometric mean titer (GMT) induced in children aged 5 to 11 was 1197.
6, which was compared with 1146.
5 of participants aged 16 to 25.
The GMT data is relatively good, revealing a strong immune response
.
At the same time, the side effects caused by the vaccine among participants aged 5-11 are consistent with those in the 16-25 age group, including fever, headache, and fatigue
Next, Pfizer and BioNTech plan to submit the data to the U.
S.
Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory agencies as soon as possible to seek approval of BNT162b2 for children under 12 years of age
.
In addition, the clinical data of the other two age groups (children 2-5 years old and children 6 months to 2 years old) in the phase 1/2/3 clinical trial are expected to be released as early as the fourth quarter of this year
Reference materials:
[1]https://
