FDA says ‘working around the clock’ to support approvals for kids under 12


12-year-old Justing Concepcion receives a dose of the Pfizer-BioNTech vaccine for the coronavirus disease (COVID-19) from registered nurse Angela Nyarko, during a vaccination event for local adolescents and adults outside the Bronx Writing Academy school in the Bronx, New York City, June 4, 2021.

Mike Segar | Reuters

The Food and Drug Administration said Friday that U.S. regulators are “working around the clock” to support the approvals of Covid-19 vaccines for kids under age 12.

So far, the PfizerBioNTech Covid vaccine has been cleared by the FDA for people as young as 12, while Moderna and Johnson & Johnson‘s vaccines have been authorized for adults.

Federal regulators are “eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible,” acting FDA commissioner Dr. Janet Woodcock and Dr. Peter Marks, the agency’s top vaccine regulator, said in a joint statement. “We have to let the science and data guide us.”

To ensure safety, clinical trials testing the vaccines are expected to include a monitoring period of at least two months after half the participants get the shots, they said.

“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,” they added.

The statement from top health officials comes as many parents say they are anxious to get their children vaccinated, especially as schools reopen and the highly contagious delta variant continues to spread. The variant has led to a surge in U.S. hospitalizations, including among young kids who are currently ineligible to get vaccinated.

President Joe Biden on Thursday detailed a sweeping plan to fight the virus, pressuring private employers to immunize their workforce as well as mandating the shots for federal employees, contractors and health-care workers.

Marks said last month the agency would move as “swiftly” as possible on approving the shot for kids under 12 once the companies submit data. “Currently, there are still trials ongoing and so the agency has to wait for the company to submit the data for those trials,” he said. “We certainly want to make sure that we get it right.”

German drugmaker BioNTech earlier on Friday said it was set to request approval across the globe to use its Covid vaccine in children as young as five over the next few weeks, according to a report.

Dr. Scott Gottlieb, a Pfizer board member, has told CNBC that he expects U.S. drug regulators to clear the Pfizer-BioNTech Covid vaccine for emergency use in children ages 5 to 11 in late fall or early winter this year.

Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the boards of Pfizer, genetic testing start-up Tempus, health-care tech company Aetion and biotech company Illumina. He also serves as co-chair of Norwegian Cruise Line Holdings′ and Royal Caribbean‘s “Healthy Sail Panel.”



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