Pfizer Plans to Ask Regulators for COVID-19 Vaccine Authorization for Young Children in October
Pfizer is eying an October submission of safety and efficacy data for its COVID-19 vaccine to U.S. drug regulators in a bid to gain authorization for shots for children between the ages of 5 and 11, two company officials said Tuesday.
Pfizer’s COVID-19 vaccine, made with German partner BioNTech, is currently only authorized for emergency use in the United States for those 12 to 15, with approval granted last month for Americans 16 and older.
Pfizer is running a trial examining the safety, tolerability, and effectiveness of its vaccine in children between the ages of 6 months and 11 years. The data from the trial for those between the ages of 5 and 11 is expected by the end of September, Frank D’Amelio, Pfizer’s CEO, told a Morgan Stanley conference on Tuesday.
That would set up an application for emergency use authorization to the Food and Drug Administration (FDA) in early October for that age group.
If all goes well, an application for authorization for kids between 6 months and 5 years would be filed weeks later, according to D’Amelio.
Pfizer CEO Albert Bourla said at a different forum that the submission for the older group could actually come by the end of September.
“Then, it is up to the FDA to take their time, and then make a decision,” he said, CNBC reported.
The application for the younger group could come by the end of October, he added.
Pfizer’s vaccine is the only one currently allowed to be used for anybody between 12 and 18 in the United States.
BioNTech said last week that it expected to file the results of the trial for 5- to 11-year-olds “with regulators across the world.”
Children are at extremely low risk of contracting severe cases of COVID-19, the disease caused by the CCP (Chinese Communist Party) virus, but Pfizer says its scientists believe vaccinating children will contribute to herd immunity, or protection against the virus in the entire population.
Federal health officials have also said they want children to get a vaccine against the virus.
“We’re waiting for the companies to submit the data to the FDA, we’re anticipating that will happen in the fall,” Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky said this week. “We will look at that data from the FDA, from the CDC, with the urgency that we all feel for getting our kids vaccinated and we’re hoping by the end of the year.”