Pfizer CEO Albert Bourla speaks at a press conference after a visit to monitor the production of the Pfizer-BioNtech COVID-19 vaccine at the US pharmaceutical company Pfizer’s factory in Puurs, Belgium, on April 23, 2021.
John Thys | Swimming pool | Reuters
Pfizer expects to release clinical trial data by the end of October on how well its Covid-19 vaccine is working in 6 month to 5 year old children, CEO Albert Bourla said Tuesday.
Covid vaccine data for children ages 5-11 will be available much sooner, he said, and may be filed with the Food and Drug Administration by the end of this month.
“Then it’s up to the FDA to take the time and then make a decision,” Bourla said during an interview at Research! America’s 2021 National Health Research Forum.
The CEO’s comments come as many parents say they are careful to get their children vaccinated, especially as schools reopen and the highly contagious Delta variant continues to spread. The exposure has led to an increase in hospital admissions in the United States, including among young children who are currently unsuitable for the syringes.
So far, the Pfizer BioNTech coronavirus vaccine has been approved by the FDA for people ages 12 and older, while Moderna and Johnson & Johnson’s vaccines have been approved for adults.
On Friday, FDA officials said they would work “around the clock” to help approve Covid vaccines for children under the age of 12.
Dr. Peter Marks, the agency’s top vaccine agency, said last month the agency would approve vaccination for children under the age of 12 as “soon” as possible once companies provide data.
“Studies are still ongoing and the agency will have to wait for the company to submit the data for these studies,” he said on August 23. “We definitely want to make sure we’re getting it right.”