Pfizer releases clinical trial data on mRNA vaccinations for children ages 5-11

Pfizer releases clinical trial data on mRNA vaccinations for children ages 5-11

On September 20, local time, Pfizer and BioNTech announced the results of a phase 2 clinical trial of the mRNA vaccine BNT162b2 in children aged 5-11. In children of this age, the vaccine exhibits good safety and a strong neutralizing antibody response. The two companies will apply to the U.S. Food and Drug Administration (FDA) for authorization in the near future.

the study is understood to be 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 wanted to know how effective the vaccine was among children in the ages of 5 to 11, 2 to 5, and 6 months to 2 years.

the two-thirds study included 2,268 children between the ages of 5 and 11, one-third of whom were in the control group receiving a physiological saline placebo;

according to pfizer's official website, the 10 μg dose is carefully selected as the preferred dose for safety, tolerability, and immunogenicity in children between the ages of 5 and 11. although this dose is one-third of the adult dose of 30 μg, the induced antibody response in children aged 5-11 years is comparable to the antibody response recorded in people 16 to 25 years of age.

The data showed that one month after the completion of the two doses of vaccination, the induced SARS-CoV-2 neutralizing antibody geometric average titer (GMT) was 1197.6 in children between the ages of 5 and 11, which revealed a strong immune response compared to the 1146.5 GMT data of participants aged 16 to 25. At the same time, the side effects of the vaccine were consistent with those in the 16-25 age group, including fever, headache and fatigue.

Next, Pfizer and BioNTech plan to submit data to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators as soon as possible to seek BNT162b2 approval for vaccinations for children under the age of 12. In addition, clinical data for two other age groups (2-5 year olds and 6 months to 2 years old) in Phase 1/2/3 clinical trials are expected to be released as early as the fourth quarter of this year.

resources:

1.Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years.