Pfizer and BioNTech proclaimed that their coronavirus vaccine is safe, efficient, and provides potent antibodies in children aged 12 to 15, which will enable them to petition for an emergency license in the United States within weeks.
Albert Burla, president and CEO of Pfizer, told Reuters that the Pfizer, BioNTech, hopes vaccination for this age group could begin before the next school year. The Pfizer vaccine is already an approved pharmaceutical product for adults outside the age of 16.
According to the Pfizer-BioNTech, the vaccine showed 100% effectiveness in preventing Covid-19 when given to children between 12 and 15 years of age in clinical trials between nearly 2,260 children. Only 18 cases of coronavirus were suspected in opponents receiving placebo, but none occurred in recipients of the vaccine.
Clinical trials of individuals aged 16 to 25 years reported health issues similar to those aged 16 to 25 in younger studies. Companies did not report any health problems for the younger population. Clinical trials in adults generally showed no adverse events, but some patients experienced injection site pain, headaches, fever, and fatigue.
Pfizer-BioNTech also studied a group of adolescents for one month after the second dose to determine antibody levels. Researchers found similar antibody levels to those in the studies between 16 and 25 years old.
The US Food and Drug Administration (FDA) and other regulators worldwide may grant vaccine an emergency license in the coming weeks so that the vaccination program can begin in this age group before the next school year. In the first round of clinical trials among younger children, Pfizer-BioNTech administered the first doses of the vaccine last week, targeting these children up to six months of