(CNSNews.com) - The Food and Drug Administration (FDA) on Monday approved booster shots for children ages 12 to 15 years old.
The FDA announced that it amended the emergency use authorization (EUA) for the Pfizer vaccine to “expand the use of a single booster dose to include use in individuals 12 through 15 years of age.”
The EUA also shortens the time between the completion of primary vaccination of the Pfizer vaccine and a booster dose to at least five months and allows for “a third primary series dose for certain immunocompromised children 5 through 11 years of age.”
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said Acting FDA Commissioner Janet Woodcock, M.D.
“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19,” Woodcock said in a statement.
Prior to the FDA’s announcement, Dr. Brett Giroir, who served as assistant HHS secretary and White House testing czar during the Trump administration, expressed concern about the anticipated approval, saying that there was no external advisory committee meeting, which is “essential for transparency.”
“I think it's probably reasonable but my concern is the FDA has gone around their normal processes. There was no external advisory committee meeting, and I think this is essential for transparency. The American people want to know this is not political. We don't have an FDA commissioner,” Giroir said.
Instead, the FDA “reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series.”
“Who told whom to not have their external advisory committee meet to provide a recommendation?” Giroir asked. “I think for transparency, for the American people to be confident, they should have the external advisory committee and they did not do that.
“Secondly, if they authorize it, and I think it's probably okay, it should not be made mandatory. The risk benefit is pretty close in the 12-15 year olds. It should be up to parents to determine that. I think Biden should make an executive order to make sure that it's not mandated for any 12 to 15-year-olds. That is my take,” he told Fox News’ “The Faulkner Focus.”