By Lauran Neergaard and Jennifer McDermott, The Associated Press
Pfizer asked the U.S. government today to approve its COVID-19 vaccine in children ages 5 to 11. It would be a major expansion that could combat an alarming rise in serious infections in children and help schools stay open.
If regulators give the go-ahead, reduced-dose kids’ shots could begin within a matter of weeks for the roughly 28 million children in that age group.
The Food and Drug Administration will have to decide whether the shots are safe and effective in elementary school-age children. An independent expert panel will publicly debate the evidence on Oct. 26.
Pfizer and its German partner BioNTech said their research shows the younger kids should get one-third of the dose now given to everyone else. After their second dose, the 5- to 11-year-olds developed virus-fighting antibody levels just as strong as those that teens and young adults get from regular-strength shots.
COVID-19 has killed at least 520 children so far in the U.S., according to the American Academy of Pediatrics. Cases in kids have increased as the delta variant has swept through the country.
Parents have differing reactions
While some mothers and fathers will take a hard stand against vaccinating their children, many parents of elementary students are eagerly awaiting authorization of the shots after 18 months of remote learning, COVID-19 scares and infections, mask debates and school quarantines.
Sarah Staffiere of Waterville, Maine, said she can’t wait for her children to get vaccinated, especially her 7-year-old, who has a rare immune disease that has forced the family to be extra cautious throughout the pandemic.
“My son asked about playing sports. ‘After you’re vaccinated.’ He asked about seeing his cousins again. ‘After you’re vaccinated.’ A lot of our plans are on hold,” said Staffiere, a laboratory instructor at Colby College. “When he’s vaccinated, it would give our family our lives back.”
Gib Brogan of Wayland, Massachusetts, said he is constantly worried about getting a call from his 10-year-old son’s school about virus exposure or infection, and he is hoping his child can be vaccinated in time for the holidays.
“I know our school district has careful protocols and procedures in place,” he said, “but every time we send him off to school, I’m thinking, ‘Are we going to get a phone call?’”
Pfizer studied the lower dose in 2,268 volunteers ages 5 to 11 and said there were no serious side effects. The study isn’t large enough to detect any extremely rare side effects, like the heart inflammation that sometimes occurs after the second dose of the regular-strength vaccine in young men.
Cindy Schilling, an elementary school principal in West Virginia, which ranks last among the states in the percentage of fully vaccinated residents, said she doesn’t think many parents will take their children to get the shot.
She said she often hears them say they are more concerned about the effects of the vaccine than COVID-19, mainly because they haven’t seen any young children get dangerously sick.
“Some parents are all for it and getting it for peace of mind,” she said, “but the majority of parents I’ve talked to will not be getting it.”
Heather Miller, a mother from Dexter, Maine, said no one in her family of six is rushing to get the vaccine. She said she wants to wait for follow-up studies on the formula.
“I’m not 100% against getting it eventually, but I kind of fall into the ‘not right now, wait and see’ category,” Miller said.
If the FDA authorizes emergency use of the kid-size doses, the Centers for Disease Control and Prevention will make a final decision, after hearing from its outside advisers.
To avoid mix-ups, Pfizer is planning to ship the lower-dose vials specially marked for use in children.
Moderna has requested FDA permission to use its vaccine in 12- to 17-year-olds and also is studying its shots in elementary school children. Both Pfizer and Moderna are studying even younger children as well, down to 6-month-olds. Results are expected later in the year.