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Pfizer and BioNTech said on Friday that they are awaiting FDA approval for the COVID-19 vaccine Comirnaty for children under 5
.
An FDA advisory panel meeting scheduled for February 15 to discuss the application was also postponed
FDA COVID-19 Children
At the FDA's request, Pfizer/BioNTech began rolling submissions to expand Comirnaty's Emergency Use Authorization (EUA) to include children 6 months to under 5 years of age
.
The companies said at the time that results from the Phase II/III study on the third injection would be available at least eight weeks after the second, with specific trial data expected in the coming months
At the FDA's request, Pfizer/BioNTech began rolling submissions to expand Comirnaty's Emergency Use Authorization (EUA) to include children 6 months to under 5 years of age
On Friday, Pfizer and BioNTech said, "Given the rapid progress in this study, we will await three-dose data as we continue to believe that it may provide a higher level of protection in this age group
.
Given the prevalence of children in this age group Infection rates remain high, especially due to the recent surge in Omicron cases, and there is an urgent need to know Comirnaty's protective effect on children
Infect
Comirnaty is an mRNA vaccine that utilizes copies of a molecule called messenger RNA (mRNA) to generate an immune response to the vaccine
.
Such vaccines deliver antigen-encoding mRNA molecules into immune cells, which use the designed mRNA as a template to synthesize the foreign proteins of the COVID-19 virus
Immune management
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