FDA authorizes Pfizer vaccine for children ages 5-11

COVID-19 vaccines for younger children are one step closer to becoming available after the Food and Drug Administration (FDA) on Friday authorized Pfizer-BioNTech’s coronavirus vaccine for emergency use in children ages 5 to 11.

Extending vaccine eligibility to children younger than 12 has been a major goal of public health officials and has been eagerly awaited by many pediatricians and families.

The FDA has been under pressure for months to move quickly to authorize vaccines for younger children, one of the final barriers to overcome in the country’s historic vaccination campaign.  

Pfizer’s vaccine is already authorized for those age 12 and older, but many parents have been waiting anxiously for the ability to protect younger children, especially as the delta variant has proved far more contagious and dangerous for them.

“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 Janet Woodcock said in a statement.

The Biden administration says it has purchased enough vaccine to inoculate all 28 million 5- to 11-year-olds in the U.S., and will distribute it through a network that will rely on more than 25,000 pediatrician’s offices, as well as community health centers, schools and pharmacies.

Children are at lower risk for severe outcomes, but they are still at risk. Kids between the ages 5 to 11 account for about 9 percent of all reported COVID-19 cases in the U.S., according to FDA data, and 39 percent of cases in people younger than 18.

While it has been declining in recent weeks, the number of new COVID-19 cases in kids remains exceptionally high. 

This past week almost 118,000 child COVID-19 cases were added, with more than 1 million over the past six weeks, according to the American Academy of Pediatrics.

In the 5- to 11-year-old group alone, more than 8,000 children have been hospitalized, and 146 children have died, according to the Centers for Disease Control and Prevention (CDC). 

A CDC panel is scheduled to meet early next week to recommend how the vaccines should be used. 

If the panel gives favorable recommendations and CDC Director Rochelle Walensky accepts them, the vaccination campaign would begin. While school is already underway, some of the first children in line could be fully vaccinated in time for Christmas. The U.S. will have 15 million shots ready the first week after the vaccine is approved.

During a press briefing late Friday, Peter Marks, the FDA’s top vaccine regulator, said the country is still “a few more months off” before vaccines are authorized for kids under age 5.

“As we get down to younger children, the benefit/risk gets to be even more of a careful consideration, because the youngest children are affected the least directly in terms of severe COVID-19,” Marks said. “We want to have robust safety sets, data sets, probably on the order of at least kind of what we saw in this case, with several thousand children who have received the vaccine, which gives us a good sense of the safety profile of the vaccine.”

A clinical trial showed that the vaccine is safe, and is nearly 91 percent effective at preventing symptomatic disease without any major complications or side effects.

The FDA authorized the vaccine for a two-dose regimen, given three weeks apart. The 10-microgram dose is one-third the amount given to people 12 years and older. 

Woodcock acknowledged there are polls showing some parents are hesitant to vaccinate their kids, but she said the situation was similar for adults early in the pandemic too.

“So we certainly hope that as people see children getting vaccinated and being protected, being able to participate in activities without concern, that more and more people will get their kids vaccinated. And you know, as we accumulate more experience with the vaccine, more comfort with the safety will occur,” Woodcock said.