Pfizer has requested U.S. approval of a booster dose of the COVID-19 vaccine for 5 to 11 year olds
Pfizer – BioNTech has submitted a request to the U.S. Food and Drug Administration (FDA) for approval for an emergency booster dose of its coronavirus vaccine for children ages 5 to 11.
The application sent by the companies contains data on the second phase of trials of the drug. According to the data, children from 5 to 11 years of age who received the booster dose about six months after the second dose of Pfizer’s BioNTech vaccine developed a strong immune response.
The companies also plan to send the research data to the European Medicines Agency and other regulatory agencies for approval in the coming weeks.