Pfizer Says Its Vaccine is Safe and Effective for Children
OREANDA-NEWS. Pfizer-BioNTech's COVID-19 vaccine has been shown to be safe and effective for children aged 5 to 11, the company said in a statement.
Pfizer's clinical trials enrolled 2,268 children aged 5 to 11 years. Two-thirds of the participants received two doses of the drug inoculated 21 days apart, and the remainder received a placebo.
"The immune response of participants who received a dose of 10 mcg is comparable to that of participants in a previous Pfizer-BioNTech study for individuals aged 16-25 who received a dose of 30 mcg ... The COVID-19 vaccine was well tolerated, side effects mainly coincided with those observed in the 16-25 age group, "the company said in a statement.
The company plans to file the research findings with regulators such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in order to obtain their approval for the use of vaccinations for children. Pfizer-BioNTech recalls that since July, the number of cases of COVID-19 infection among children in the United States has increased by 240%, which underlines the need for vaccination in this age group.
Earlier, BioNTech, which developed a vaccine against COVID-19 in conjunction with the American Pfizer, expressed hope to receive regulatory approval of its vaccine intended for children aged 5 to 11 years old, the production of such a drug is already being prepared.
The company stressed that by the end of the year data on the study of the vaccine, which is intended for children from six months, is also expected.