FDA authorizes Pfizer’s Covid vaccine for children ages 5 to 11

WHAT YOU NEED TO KNOW:

• The U.S. FDA on Friday authorized Pfizer-BioNTech’s COVID-19 vaccine for children ages 5 to 11.
• “The FDA has determined this Pfizer vaccine has met the criteria for emergency use authorization,” the FDA said in a news release.
• The shots to be administered to children ages 5 to 11 will be one-third the dose approved for those 12 and older.

The Food and Drug Administration on Friday gave authorization to the use of Pfizer-BioNTech’s Covid-19 vaccine for kids ages 5 to 11. The approval will make the vaccine available to 28 million children in the U.S.

The Centers for Disease Control and Prevention will have to sign off before shots can be administered. The agency set an advisory committee meeting to review the pediatric doses next week. The CDC is expected to clear them for public distribution immediately thereafter.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA Commissioner Dr. Janet Woodcock said in a statement.

On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted overwhelmingly to approve a smaller dose of the Pfizer vaccine for young children.

Pfizer said its low-dose vaccine for kids is more than 90% effective in preventing symptomatic infection. It also said the shots were well tolerated in young children, producing side effects comparable with those seen in a study of people ages 16 to 25.

The company added the shots to be administered to children ages 5 to 11 will be one-third the dose approved for those 12 and older.

Many parents say they are anxious to get their kids vaccinated with schools now open across the U.S. and the delta variant of the coronavirus driving a surge in children’s cases.

As of Oct. 21, nearly 6.3 million children have tested positive for Covid since the onset of the pandemic, according to the American Academy of Pediatrics. Covid-19 is the eighth-highest killer of kids ages 5 to 11 over the past year, a CDC official told the FDA committee Tuesday.

As of Oct. 17, 691 deaths from Covid have been reported in the U.S. in kids under age 18, with 146 deaths in the 5 through 11 years age group, the FDA said Friday.

The Biden administration has said it’s already procured enough doses to vaccinate all 28 million 5- to 11-year-olds in the U.S. It confirmed it is ready to roll out the first 15 million shots this week.

Dr. Peter Marks, the FDA’s top vaccine regulator, said the U.S. is likely “a few more months off” before vaccines are authorized for kids under age 5.

Source: CNBC