The Food and Drug Administration (FDA) of the United States Friday issued an emergency clearance for the use of the Pfizer / BioNTech vaccine against COVID-19 on children aged 5 to 11, it was announced. The decision came three days after a recommendation from a scientific committee.
After the FDA's approval, the Centers for Disease Control and Prevention (CDC) will have to study and decide whether to authorize immunization against Covid-19 in this age group, which is estimated to encompass some 28 million people in the US.
The FDA has said on its website that it based its decision on the effectiveness of the Pfizer drug, which reached 90.7% in preventing Covid-19 among children 5 to 11 years old. The percentage was said to be comparable with that of the group of people between 16 and 25 years of age. The agency also explained the efficacy data came from an ongoing study of 4,700 children in the United States, Finland, Poland and Spain. It also stated that after a study of approximately 3,100 children of that age, no serious side effects had been detected.
For children ages 5 to 11, the FDA indicated that the Pfizer / BioNTech Covid-19 vaccine should be given in two doses three weeks apart. According to the FDA, these people should be given a “lower dose” of 10 micrograms compared to the 30 micrograms used on people 12 and older. The FDA also said COVID-19 cases among children aged 5 to 11 accounted for 39% of infections in people under 18 years of age in the United States.
According to FDA data, 146 of the 691 deaths from COVID-19 among children under 18 years old registered in the United States up to October 17, were of children between 5 and 11 years old.