The COVID-19 pandemic is a major global public health problem that has had a profound effect on modern reality. Vaccination is a way out of the pandemic, and there are already approved vaccines for people over 12 years of age. For the safe operation of school units and the smooth education of students, the existence of safe and effective vaccines for students and younger is considered important. Thus, a phase 1 study was designed to determine the ideal dose, followed by a randomized phase 2-3 study to study extensively the safety, immunogenicity and efficacy of two doses of the Pfizer vaccine against placebo in 6-month-old children. up to 11 years old.
The Doctors of the Therapeutic Clinic of the Medical School of the National and Kapodistrian University of Athens Theodora Psaltopoulou, Panos Malandrakis, Giannis Danasis and Thanos Dimopoulos (Rector of EKPA) summarize the relevant publication in NEJM for the age group 5 to 11 years. In phase 1, 48 children were studied in three doses of 10 μg, 20 μg, and 30 μg, and the 10 μg dose was selected. In phase 2-3 they were included 2268 children of which 1517 received the vaccine and other placebo.
At the time of data analysis, the mean follow-up was 2.3 months, and no significant adverse reactions were described. One month after the second dose the ratio of mean neutralizing antibody titer values ​​in the 5-11 age group to the 16-25 age group was 1.04, meeting the vaccine efficacy criteria set out in the study designς.
COVID-19 disease 7 days after the second dose showed only 3 children who received the vaccine, but 16 children who received placebo (efficacy 90.7%). These data support the safety of the 10 μg dose in two doses with a 21-day difference of the BNT162b2 vaccine in children 5-11 years of age and based on these the World Medicines Agency has approved the vaccination of children of this age.
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