FDA panel recommends approval of Moderna, Pfizer vaccines for young children

June 15 (UPI) -- Food and Drug Administration advisers are recommending the FDA approve Moderna and Pfizer COVID-19 vaccines for children as young as six months.

Wednesday's recommendation by a panel of experts is expected to be upheld by the FDA Commissioner, as well as the Centers for Disease Control and Prevention, before the weekend. If approved, the vaccines could be available as early as Tuesday.

The FDA panel voted 21-0 to approve Moderna's COVID-19 vaccine, saying it is safe for children ages six months to six years. The panel also voted to recommend the Pfizer-BioNTech vaccine for children six months to five years.

Currently, no vaccines have been approved for children ages five and under.

Pfizer and BioNTech's vaccine would be offered to young children in three doses to provide protection during the omicron wave, while Moderna's regimen would require two doses.

On Friday, the FDA reviewers released documents supporting their decision.

"Available data support the effectiveness of the Moderna COVID-19 vaccine in preventing symptomatic COVID-19 in pediatric age groups from six months through 17 years of age," the reviewers said in the document.

While reviewers of the Moderna and Pfizer vaccines noted risks from COVID-19 infections in young children are relatively low, they want to give parents the option to vaccinate their youngest children.

"While no severe COVID-19 cases were reported among participants six months through 17 years in clinical studies, vaccine efficacy against severe disease and hospitalizations is expected to be higher compared to vaccine efficacy against non-severe COVID-19 as observed in the adult clinical trial and in real-world studies," the reviewers said.

"We've got to be transparent about the real risks of COVID-19 for children," Dr. James Hildreth, Sr., CEO of Meharry Medical College in Nashville, told USA Today. "For those parents who choose to do so, especially those parents of kids that have underlying conditions, this is a choice they should have and I'm pleased that they'll have it."

The 19.6 million children ages six months to five years is one of the last groups of people in the United States still waiting for shots.

"There are so many parents who are absolutely desperate to get this vaccine, and I think we owe it to them to give them the choice," Dr. Jay Portnoy, a professor of pediatrics at Children's Mercy Hospital in Kansas City, Mo., told the Wall Street Journal.

"So, what does this mean for you if you're a parent or a pediatrician," said White House Coronavirus Response Coordinator Dr. Ashish Jha last week. "Realistically, it means we could see shots in arms of kids under five as early as the week of June 20th."