Pfizer CEO Albert Bourla says that he expects COVID-19 vaccine trials for children ages 5 to 11 will be completed in September.
On Monday, the Food and Drug Administration approved the Pfizer-BioNTech vaccine for full use in people ages 16 years and older.
What are the details?
During a Monday interview with NBC News’ Lester Holt, Bourla said that Pfizer is running “very large studies right now” on children younger than 12 years old and anticipates that those studies will end in September, at which point the biopharmaceutical company will submit its data to the FDA for emergency use authorization.
According to the network, the company expects further data on toddlers and children up to 4 years old soon thereafter.
Dr. Peter Marks, the FDA’s director for its Center for Biologics Evaluation and Research, said that the trials continue and that the agency has to wait for Pfizer to submit the data from their trials in order to maintain a “good safety dataset.”
“[W]e certainly want to make sure that we get it right in the children ages 5 through 11 and then even younger children after that,” Marks said.
On Monday, Bourla said that he has high hopes that the FDA approval will encourage vaccine-hesitant to get inoculated against COVID-19.
“Based on the longer-term follow-up date that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Bourla said in response to the news. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity.”
What else?
Following the FDA’s Monday announcement, the American Academy of Pediatrics called for the agency to “work aggressively to authorize a vaccine for ages 11 and younger” as the highly contagious Delta variant wreaks havoc with the numbers of children being diagnosed with the coronavirus.
“The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” American Academy of Pediatrics President Lee Savio Beers said in a statement. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”
Pfizer CEO Speaks On Full FDA Approval
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Anything else?
Earlier this month, Bourla said that he believed that the vaccines for children within the 5-12 age group would be “very effective.”
“And they will also safe, but the studies are ongoing,” he added. “So we are waiting to finalize them so that we can properly analyze all the data, and then submit them again, I believe that we should be ready after summer to submit [to the FDA].”