U.S. pharmaceutical maker Pfizer on Thursday said it has formally sought emergency use approval for the Govit-19 vaccine in children between the ages of five and 11.
The latest corona virus wave, driven by the delta variant, is affecting a large number of children, and vaccinating young people is critical to keeping schools open and ending the epidemic.
In late September, Pfizer and Biotech, the German biotechnology company that developed the vaccine, began submitting data to food and drug regulators for much-anticipated approval.
Pfizer tweeted early Thursday morning that both organizations had officially submitted “our request” to the FDA for the Emergency Use Authorization (EUA) of our # COVID19 vaccine for children aged 5 to 12.
“We are committed to working with the FDA with the ultimate goal of helping to protect children from this serious public health threat,” Pfizer said.
The FDA said it had scheduled a meeting of an advisory committee last week to review the data on October 26, before commenting on whether the approval should be granted.
The company previously said it could complete its review “in weeks rather than months” once formal submission is complete.
The U.S. Centers for Disease Control and Prevention will then issue recommendations for use for health providers managing shots.
“If there is approval or approval and the CDC recommendation, we are ready, we have the supply,” White House Govt coordinator Jeff Giants told CNN following the announcement.
I think we can all agree that getting a safe and effective vaccine for children between the ages of five and 11 is the most important next step in our fight against the virus.