Pfizer said it plans to file for US approval of its Covid-19 vaccine for children aged six months to five years old in November as part of a race to broaden the vaccine’s eligibility. The vaccine, which was developed in collaboration with BioNTech, was the first to be approved for use in children aged 12 and up. Pfizer had already stated that it expected to submit for approval from the US Food and Drug Administration in early October for children aged five to eleven.
On Tuesday, Pfizer gave the first peek of its proposed timeframe for approving the vaccine in infants as young as six months old. “We would expect to have . . . data for children between the ages of six months and five years old that we would file with the FDA,” D’Amelio said. “I’ll call it in the weeks shortly thereafter the filing of the data for the five- to 11-year-olds.”In November, the company aimed to “go file” for this age group, said Frank D’Amelio, chief financial officer. D’Amelio said the schedule was based on the assumption that “all of the data is positive” at Tuesday’s Morgan Stanley Global Healthcare Conference.
According to the most current statistics collected in the United States, the hospitalization rate for youngsters aged four and under was only 2.2 per 100,000, compared to 15.8 per 100,000 among the mostly-vaccinated over-65s. Scott Gottlieb, a Pfizer executive, and former FDA commissioner, largely supported D’Amelio’s timing. On Tuesday at a Financial Times conference, he claimed that regulatory approval for the BioNTech/ vaccine in youngsters as young as six months old might occur “late 2021, early 2022.”The BioNTech/Pfizer vaccine for children under the age of six is less effective than the others. Children aged six months to five years are given a three microgram vaccine in clinical trials, compared to 10 micrograms for those aged five to eleven and 30 micrograms for adults.