Covid-19 vaccine update
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Pfizer said it plans to apply for US approval of the Covid-19 vaccine for children aged 6 months to 5 years in November as it competes to expand its eligibility for jabs.
The vaccine developed in partnership with BioNTech beginning Pfizer has already stated that it is licensed for children ages 12 and older, and that Pfizer plans to apply for a green light for children ages 5-11 from the US Food and Drug Administration in early October.
On Tuesday, Pfizer provided the first glimpse of the intended timeline for the approval of jabs for 6-month-old babies. Chief Financial Officer Frank Damerio told an industry conference in November that he wanted to “apply” for this age group.
“We expect to have … Data for children aged 6 months to 5 years to submit to the FDA,” said D’Amelio. “Call it as soon as you submit the data between the ages of 5 and 11.”
D’Amelio spoke at the Morgan Stanley Global Healthcare Conference on Tuesday, adding that the estimated timeline assumes “all data are positive.”
Vaccination of babies is considered an important step in controlling a pandemic, given that day care centers and schools can function as virus breeding grounds. In addition, Covid infections and rising levels of hospitalization in the United States require children to have access to the vaccine, especially as a school. Resume In the fall semester.
Covid hospitalization rates for children under the age of 4 in the week leading up to August 14 were about 10 times higher than in the week leading up to June 26. report Published last week by the US Centers for Disease Control and Prevention.
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However, according to the latest report data The hospitalization rate for children aged 0-4 years collected in the United States was only 2.2 per 100,000, while the predominantly vaccinated children aged 65 and over were 15.8 per 100,000.
Pfizer’s director and former FDA Commissioner Scott Gottlieb has taken a rough look at D’Amelio’s timeline. At the Financial Times conference on Tuesday, he said BioNTech / Pfizer jab regulatory approvals for 6-month-old children could come “late 2021 to early 2022.”
The BioNTech / Pfizer Jab for the youngest kids is less powerful than other kids. In clinical trials, infants aged 6 months to 5 years receive 3 micrograms of the vaccine, 10 micrograms for 5-11 years and 30 micrograms for adults.
Pfizer Apply for Jab Green Light for Toddlers in November
Source link Pfizer Apply for Jab Green Light for Toddlers in November