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Pfizer said it hoped to apply in November for U.S. authorization of its Covid-19 vaccine for children between six months and five years old, as it runs to expand its eligibility for the jab.
The vaccine, developed in collaboration with BioNTech, was the first authorized for use in children 12 years of age and older and Pfizer had already said it planned to seek approval from the Food and Drug Administration of the United States. USA for children between five and 11 years old. old in early October.
On Tuesday, Pfizer offered the first view of its planned timeline for jab clearance on babies as young as six months old. Frank D’Amelio, chief financial officer, told an industry conference that the company expected to “file files” for that age group in November.
“It simply came to our notice then. . . data on children between the ages of six months and five that we would send to the FDA, “D’Amelio said.” I’ll call her in a few weeks after the data file for children ages five to eleven. ”
At Morgan Stanley’s Global Healthcare conference on Tuesday, D’Amelio added that the alleged chronology meant that “all the data is positive.”
Vaccination of babies is seen as a crucial step in taming the pandemic, as schools and child care centers can serve as the cradle of the virus. And rising levels of covidae infection and hospitalization in the U.S. have boosted requests for vaccines to be made available to children, especially as schools reopen during the fall period.
In the week ending Aug. 14, Covid’s hospitalization rate in children four years of age or younger was nearly ten times higher than the week ended June 26, according to a report released last week by the Centers for Disease Control and Prevention.
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However, according to the most recent data collected in the United States, the hospitalization rate among children four years of age or younger was only 2.2 per 100,000, compared to 15.8 per 100,000 among those over 65 vaccinated years.
Scott Gottlieb, director of Pfizer and former FDA commissioner, amply confirmed the timeline given by D’Amelio. At a Financial Times conference on Tuesday, he said the regulatory clearance for the BioNTech / Pfizer dam on children up to six months could reach “late 2021, early 2022.”
The BioNTech / Pfizer blow for younger children is less powerful than the others. In clinical trials, children aged six months to five years are given a 3 microgram vaccine, compared with 10 micrograms for those aged five to 11 years and 30 micrograms for adults.