Cofounder and chief medical officer of BioNTech, Ozlem Tureci, spoke with German News Outlet Der Spiegel about the company's plans. “We will be presenting the results from our study on 5-to-11-year-olds to authorities around the world in the coming weeks,” Tureci explained. The company will seek clearance from countries to implement the use of the smaller dosage for children.
The vaccine is already approved for children 12 and older as the company races to gain approval for use in children under 12. In a joint statement, Food and Drug Administration (FDA) Commissioner Dr. Janet Woodcock and Dr. Peter Marks announced that they are “eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible.” The statement went on to announce that “we have to let the science and data guide us.”
The FDA detailed the approval process for vaccine use for children under 12: “Once the manufacturers complete the relevant portion of their clinical trials, they have to complete the analysis of the data from the studies to understand how safe the vaccine is and how well it works in the clinical trial participants.”
Dr. Marks stated that “currently, there are still trials ongoing and so the agency has to wait for the company to submit the data for those trials. We certainly want to make sure that we get it right”:
Last month, Pfizer board member Dr. Scott Gottlieb informed Squawk Box about the potential timeline regarding the approval of vaccine use in children under 12:
If the FDA sticks to its normal timeline, in terms of how it reviews these applications, you would expect that review to be a four to six-week review for a potentially emergency use authorization, so that puts you on a timeline where you're late fall, early winter.
The Pfizer board member explained that a potential approval by the FDA in November or December would be the “optimized scenario if everything goes right and this is an accelerated review like the other applications have been.”
Gottlieb suggested that higher rates of infection in children could leverage the FDA to attempt to authorize the vaccine sooner rather than later. “If we continue to see these accelerating rates of infections in kids, particularly as the delta variant moves to the Northeast, I think there could be more pressure to try and make an earlier authorization for a vaccine,” he said.