Covid-19 vaccine update
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Pfizer said it expects to apply for the U.S. approval of its Covid-19 vaccine for children between 6 months and 5 years old in November because it is racing to expand eligibility for vaccination.
The vaccine developed in cooperation with BioNTech is First Approved for use in children 12 years of age and older, Pfizer has stated that it plans to apply to the U.S. Food and Drug Administration for approval for use in children aged 5 to 11 in early October.
On Tuesday, Pfizer announced for the first time its scheduled timetable for approval of injections in 6-month-old babies. CFO Frank D’Amelio said at an industry conference that the company hopes to “apply” for people of this age in November.
“We hope to have… the data we will submit to the FDA for children from 6 months to 5 years old,” D’Amelio said. “I will call it a data archive for children aged 5 to 11 in the next few weeks.”
At the Morgan Stanley Global Healthcare Conference on Tuesday, D’Amelio added that the hypothetical schedule assumes “all data is positive.”
Given that childcare facilities and schools can become hotbeds of the virus, vaccinating infants is seen as a key step in containing the pandemic.The rising levels of Covid infection and hospitalizations in the United States have prompted calls for vaccines for children, especially in schools reopen Fall semester.
According to a report, as of the week of August 14, the hospitalization rate for children 4 years of age and younger for new coronary pneumonia was almost 10 times that of the week as of June 26. report Released by the Centers for Disease Control and Prevention last week.
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However, according to the latest data Data collected in the United States shows that the hospitalization rate for children aged 0-4 is only 2.2 per 100,000, and among most vaccinated children over 65, the hospitalization rate is 15.8 per 100,000.
Scott Gottlieb, director of Pfizer and former FDA commissioner, has extensively confirmed the timetable given by D’Amelio. In his speech at the Financial Times meeting on Tuesday, he said that regulators may approve BioNTech/Pfizer injections to 6-month-old children “at the end of 2021, early 2022”.
BioNTech/Pfizer is not as effective as others for the stimulation of the youngest child. In clinical trials, infants between 6 months and 5 years of age were vaccinated with 3 micrograms, compared with 10 micrograms for children aged 5 to 11 years and 30 micrograms for adults.