Pfizer data on Covid vaccine for children under 5 could arrive in late October, CEO says

Pfizer plans to publish clinical trial data on the effectiveness of its Covid-19 vaccine in children 6 months to 5 years of age as early as the end of October, CEO Albert Bourla said on Tuesday.

Data on the Covid vaccine for children aged 5 to 11 will arrive much sooner, he said, potentially ready to be submitted to the Food and Drug Administration by the end of this month.

“Then it’s up to the FDA to take their time and then make a decision,” Bourla said in an interview with Research’s National Health Research Forum 2021! America.

The CEO’s comments come as many parents say they are eager to get their children vaccinated, especially as schools reopen and the highly contagious delta variant continues to spread. The strain has led to an increase in hospitalizations in the United States, including among young children who are not currently eligible to receive the vaccines.

So far, the Pfizer-BioNTech coronavirus vaccine has been cleared by the FDA for people as young as 12, while Moderna and Johnson & Johnson’s vaccines have been cleared for adults.

FDA officials said on Friday they were “working tirelessly” to support approvals of Covid vaccines for children under 12.

Dr Peter Marks, the agency’s main vaccine regulator, said last month the agency would act as “quickly” as possible to approve the vaccine for children under 12 once the companies will have submitted data.

“Currently, trials are still ongoing, so the agency has to wait for the company to submit data from those trials,” he said on August 23. “We definitely want to make sure we’re doing it right.”