The application contains data on the second phase of drug testing.
The Pfizer – BioNTech consortium has sent a request to the US Food and Drug Administration (FDA) for approval for the emergency use of a booster dose of its coronavirus vaccine among children aged 5 to 11 years. This is stated in a statement published on the Pfizer website.
“Pfizer and BioNTech today submitted an application to the U.S. Food and Drug Administration [FDA] for permission to use the emergency <…> booster dose of the Pfizer – BioNTech COVID-19 vaccine among children from 5 to 11 years old <…>,” the statement said.
The application sent by the companies contains data on the second phase of drug trials. According to these data, children aged 5 to 11 years who received a booster dose about six months after the introduction of the second dose of the Pfizer – BioNTech vaccine developed a strong immune response.
The companies also plan to send the research data to the European Medicines Agency and other regulatory authorities for approval in the coming weeks.