Experts from the Food and Drug Administration (FDA) warned Monday about potential risks of vaccinating children under the age of 12. White House chief medical adviser Dr. Anthony Fauci, however, opined Monday that such an approval should come in “a couple of months.”
“That would be a great concern that people would vaccinate children, because we don’t have the proper dose, and we don’t have the safety data, nor do we have all the efficacy data,” acting FDA Commissioner Janet Woodcock said during a press briefing Monday, according to The Hill.
The note of caution comes amid the FDA’s full approval of the COVID-19 vaccine developed by Pfizer and BioNTech for individuals 16 years of age or older.
Woodcock added that it is necessary to gather all the relevant data before any recommendations regarding the vaccines’ safety for children under 12 can be made.
Although the FDA granted full approval for the Pfizer COVID-19 vaccine for ages 16 and up on Monday, officials have added a note of caution to parents and doctors: The shot isn’t yet intended for use in kids. https://t.co/bza5w9m1AY pic.twitter.com/XNUxk3UEGp
— WebMD (@WebMD) August 24, 2021
“I’m a fan of vaccines. I would be loath to vaccinate my 9 or 10 year old until I saw the data,” Paul Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said, The Hill reported.
Director of the National Institutes of Health (NIH) Francis Collins said Monday that the vaccine’s authorization for the use in kids aged 5 to 11 should be expected no sooner than “the end of 2021.”
Fauci disagreed with Collins, heralding a much quicker completion of the approval procedure during his Monday interview with NPR. (RELATED: Fauci Says Everyone Is Likely To Need Booster Shots ‘At Some Time In The Future’)
“Right now if you look at the calendar, if you take Pfizer and you look at the data that’s been collected, you know, it depends. You could conceivably get an emergency use authorization in the mid-to late fall for individuals 5 to 11,” he said.
“It may be that when the FDA looks at the data, they may feel they want a little bit more time for safety. And that may end in a couple of months,” Fauci conceded.