The
The federal agency published its analysis of the drug on its website ahead of a Wednesday meeting when its
Last week, the regulators posted documents stating the
"Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine three-dose primary series ... in preventing COVID-19 in the age group of six months through four years," it said.
The report underscored the benefit of a vaccine for those in this demographic, stating rates of hospitalization and death due to COVID-19 are higher among young children than adolescents five through 17 years of age and comparable to those 18-25.
"Given the uncertainty of the COVID-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children six months through four years of age will likely have a beneficial effect on COVID-19 associated morbidity and mortality in this age group," it said.
SARS-CoV-2, which means severe acute respiratory syndrome coronavirus 2, is the official name of the virus that causes COVID-19.
The vaccine regimen proposed consists of the first two doses being administered three weeks apart followed by a third dose at least eight weeks after the second dose.
According to the document, Pfizer-BioNTech submitted data of a trial of 1,415 children who received the three-dose regimen and shows the drug has a vaccine efficiency of 80.4%, producing 10 COVID-19 cases, seven of which were from the placebo group.
If the advisory panel recommends amending the emergency authorization, approval from the
Dr.
On Thursday, she said the inoculation drive in earnest could begin
If both the FDA and
"We have waited a long time for this moment," she said. "It would mean that for the first time essentially every American, from our oldest to our youngest, would be eligible for the protection that vaccines provide."
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