According to CNET reports, Pfizer and its partner biontech have resubmitted their application, hoping that the three-dose covid-19 vaccine for children aged 6 months to 4 years can be authorized by the U.S. Food and Drug Administration (FDA) for emergency use** It is reported that FDA accepted Pfizer's Application on Wednesday and checked the relevant data.
"Pfizer and biontech have completed the rolling application for emergency use authorization to the U.S. Food and drug administration," Pfizer said in an email statement.
Pfizer had previously asked the FDA to authorize its vaccine for children aged 6 months to 4 years in February, but postponed the request while waiting for more data. Pfizer said last week that trials showed that its three doses of vaccine produced a strong immune response in children under the age of 5.
Before the expected submission, FDA said last week that its vaccine and related biological products advisory committee would meet on June 15 to discuss Pfizer and Moderna's application for emergency use authorization of vaccines for children aged 6 months and above.
Moderna requested approval at the end of April. The vaccines provided by Moderna for children under 5 years of age include two doses of 25 micrograms of vaccine (a quarter of the adult Moderna dose). Pfizer's vaccine is three doses of 3 micrograms -- one tenth of the adult dose.
FDA told ABC News in a statement: "we recognize that parents are eager to vaccinate their children with covid-19 vaccine. Although FDA cannot predict how long it will take to evaluate the data and information, we will review any EUA requests we receive as soon as possible using a science based method."
FDA did not immediately respond to requests for comment. The vaccine must be approved by the committee before the FDA plenary meeting, and then approved by the Centers for Disease Control and Prevention (CDC).