On Monday, a statement was issued by Pfizer and BioNTech which stated that the results of the clinical trials indicate that the vaccine was safe, well-tolerated, and displayed robust neutralizing antibody responses in children between the age of 5 to 11 years. The data of the clinical trials will be submitted to regulatory bodies in the European Union, the United States, and around the world “as soon as possible”.
Albert Bourla, the CEO of Pfizer, stated the pediatric cases of Covid-19 have witnessed an increase by 240% in the US, and they are eager to provide the protection of the vaccines to the younger generation.
Both the companies added that 30 microgrammes of vaccine are administered to the older age groups, but children in the age group of 5-11 years received two doses of 10 microgrammes of vaccine during the clinical trials. The statement added that a 10 microgram dose was carefully selected as the preferred dose for the children between the age of 5 to 11 years for safety, tolerability, and immunogenicity.
Furthermore, the statement said that the side effects observed in this age group were generally comparable to those observed in participants between the age of 16 to 25 years. The most commonly reported side effects included pain, swelling at the site the vaccine was injected, headache, chills, and fever.
Israel has granted special authorization to the use of Pfizer vaccine at a lower dosage to children at significant risk of serious illness or death from Covid-19 in the 5-11 age group.
The clinical trials of Pfizer and BioNTech are still underway for infants between six months to two years of age, and for children between 2 and 5 years of age, and the companies stated that the data from these clinical data might be available by the fourth quarter of this year. A total of 4,500 children between 6 months to 11 years of age have enrolled in clinical trials of Pfizer-BioNTech in the US, Finland, Poland, and Spain.