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Pfizer May Release Vaccine Data on Kids Under Age 5 This Fall

The information will indicate if the FDA will approve the vaccine for young children

The CEO of Pfizer says the pharmaceutical company may release clinical trial data on the effectiveness of the vaccine on children ages 6 months and 5 years old.

The company may also be ready to release data from vaccine studies conducted on children ages 5 to 11 years old.

“Then, it is up to the FDA to take their time, and then make a decision,” Albert Bourla said Tuesday. The pharmaceutical executive was interviewed at the Research!America’s 2021 National Health Research Forum.

In a joint statement last week, FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, the agency’s top vaccine regulator, said they are “eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible.”

“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 strain has led to a surge in U.S. hospitalizations, including among young kids who are currently ineligible to get vaccinated,” says CNBC.

Pfizer’s vaccination is currently approved by the Food and Drug Administration for kids ages 12 and up. Moderna, which has only been approved for people 18 and up, has filed for an Emergency Use Authorization with the FDA. They have asked the agency to approve their vaccination for children 12 and older, per Fox News

Dr. Scott Gottlieb, a Pfizer board member, told CBS News, “In a best-case scenario, given that timeline they’ve just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween.”

Gottlieb was the 23rd commissioner of the FDA.

The New York Post reports that “the FDA has said it would take weeks, not months, to determine whether to OK the two-dose vaccine for kids ages 5 to 11.

Pfizer, the only fully approved FDA vaccine, has been testing its shot on kids 2 years and older and has previously said data on children 2 to 5 could arrive just after September.

The FDA is scheduled to meet this Friday to discuss booster shots. Announcements could follow regarding who is recommended to receive the extra dose. 

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