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The FDA this Friday authorized the emergency use of Pfizer and BioNTech's Comirnaty to prevent COVID-19 , including children aged 5 to 11
.
The vaccine is given as a two-dose primary series, 21 days apart, but the dose for individuals over 12 is 10 micrograms
FDA prevents children with COVID-19
The FDA advisory committee approved the emergency use of Comirnaty in children aged 5 to 11 with a result of 17 votes to 0, meaning that the benefits of Comirnaty outweigh the risks of its use in children aged 5 to 11 years
.
The agency pointed out that the US Centers for Disease Control and Prevention (CDC) Immunization Practice Advisory Committee plans to meet next week to discuss further clinical recommendations for the vaccine
immunity
The US government has purchased sufficient doses of Comirnaty to vaccinate all children aged 5 to 11 years in the United States, and recently agreed to purchase another 50 million doses of pediatric vaccines for children under 5 years of age
.
Pfizer and BioNTech recently reported data from a Phase II/III study, showing that Comirnaty is 90.
7% effective in preventing symptomatic diseases in children aged 5 to 11
.
The results previously announced by the two companies showed that the vaccine was generally well tolerated in the trial and induced a neutralizing antibody response comparable to that of people aged 16 to 25
Pfizer and BioNTech recently reported data from a Phase II/III study, showing that Comirnaty is 90.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, commented: "We have full confidence in the safety, effectiveness and manufacturing data behind this authorization
.
"
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