Pfizer seeks approval from FDA to authorize its Covid-19 vaccine for children aged 5 to 11
US Pharmaceutical firm Pfizer and its German partner BioNTech have asked the Food and Drug Administration (FDA) to authorize their coronavirus vaccine for emergency use in children ages 5 to 11 in USA on Thursday i.e. today.
As reported by The New York Times, it is estimated that around 28 million children in the country would be eligible for inoculation if the regulators provide a green signal. The process is expected to take several weeks. The first made coronavirus vaccine for children will be available for children younger than 12 years.
Following which, FDA advisory committee is scheduled to meet on October 26 to discuss Pfizer- BioNTech’s paediatric vaccine said the officials. They also added that authorization could occur between Halloween (October 31) and Thanksgiving (November 25).
Meanwhile, Pfizer tweets,” With new cases in children, US continues to be at the highest level, and this particular submission is an important step to save the children who are fighting against covid-19″.
Pfizer and BioNtech reportedly have submitted the initial data to FDA last month for a regimen of two 10-microgram doses in children, which is smaller than what is given to the older groups.
Around 2600 or more trials took place, where children were given doses. Three weeks apart, the companies found that they had comparable antibody responses to people between age group of 16 to 26
It is to be noted that FDA will move quickly on the request and has a meeting to consider it scheduled and pronouncement is expected between late October and late November.
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