ALL NEWS

FDA advisers move COVID-19 shots closer for kids under 5

Jun 15, 2022, 1:58 PM | Updated: 2:01 pm

a small boy recieves a COVID-19 vaccine in China...

FILE - A boy receives a dose of China's Sinovac COVID-19 coronavirus vaccine at a community vaccination center in Hong Kong on Feb. 25, 2022. U.S. (AP Photo/Kin Cheung, File)

(AP Photo/Kin Cheung, File)

COVID-19 shots for U.S. infants, toddlers and preschoolers moved a step closer Wednesday.

The Food and Drug Administration’s vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for the littlest kids.

The outside experts voted unanimously that the benefits of the shots outweigh any risks for children under 5 — that’s roughly 18 million youngsters. They are the last age group in the U.S. without access to COVID-19 vaccines and many parents have been anxious to protect their little children.

If all the regulatory steps are cleared, shots should be available next week.

“This is a long-awaited vaccine,” said one panel member, Dr. Jay Portnoy of Children’s Hospital in Kansas City, Missouri. “There are so many parents who are absolutely desperate to get this vaccine and I think we owe it to them to give them a choice to have the vaccine if they want to.”

Dr. Peter Marks, FDA’s vaccine chief, opened the meeting with data showing a “quite troubling surge” in young children’s hospitalizations during the omicron wave, and noted 442 children under 4 have died during the pandemic. That’s far fewer than adult deaths, but should not be dismissed in considering the need for vaccinating the youngest kids, he said.

“Each child that’s lost essentially fractures a family,” Marks said.

FDA reviewers said both brands appear to be safe and effective for children as young as 6 months old in analyses posted ahead of the all-day meeting. Side effects, including fever and fatigue, were generally minor in both, and less common than seen in adults.

The two vaccines use the same technology but there are differences. In a call with reporters earlier this week, vaccine experts noted that the shots haven’t been tested against each other, so there’s no way to tell parents if one is superior.

“That is a really important point,”‘ said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. “You can’t compare the vaccines directly.”

If the FDA agrees with its advisers and authorizes the shots, there’s one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation after its own advisers meet Saturday. If the CDC signs off, shots could be available as soon as Monday or Tuesday at doctor’s offices, hospitals and pharmacies.

Pfizer’s vaccine is for children 6 months through 4 years; Moderna’s vaccine is for 6 months through 5 years.

Moderna’s shots are one-quarter the dose of the company’s adult shots. Two doses appeared strong enough to prevent severe illness but only about 40% to 50% effective at preventing milder infections. Moderna has added a booster to its study and expects to eventually offer one.

Pfizer’s shots are just one-tenth its adult dose. Pfizer and partner BioNTech found that two shots didn’t provide enough protection in testing, so a third was added during the omicron wave.

Pfizer’s submitted data found no safety concerns and suggested that three shots were 80% effective in preventing symptomatic coronavirus infections. But that was based on just 10 COVID-19 cases; the calculation could change as more cases occur in the company’s ongoing studies.

The same FDA panel on Tuesday backed Moderna’s half-sized shots for ages 6 to 11 and full-sized doses for teens. If authorized by the FDA, it would be the second option for those age groups. Currently Pfizer vaccine is their only choice.

The nation’s vaccination campaign started in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with health care workers and nursing home residents first in line. Teens and school-age children were added last year.

Moderna said in April that it is also seeking regulatory approval outside the U.S. for its little kid shots. According to the World Health Organization, 12 other countries already vaccinate kids under 5, with other brands.

In the U.S., it remains uncertain how many parents want their youngest vaccinated. While COVID-19 is generally less dangerous for young children than older kids and adults, there have been serious cases and some deaths. Many parents trying to keep unvaccinated tots safe have put off family trips or enrolling children in daycare or preschool.

Still, by some estimates, three-quarters of all children have already been infected. Only about 29% of children aged 5 to 11 have been vaccinated since Pfizer’s shots opened to them last November, a rate far lower than public health authorities consider ideal.

Dr. Nimmi Rajagopal, a family medicine physician at Cook County Health in Chicago, said she’s been preparing parents for months.

“We have some that are hesitant, and some that are just raring to go,” she said.
___
Follow AP Medical Writer Lindsey Tanner at @LindseyTanner.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

We want to hear from you.

Have a story idea or tip? Send it to the KSL NewsRadio team here.

All News

One person died after being struck by a northbound Green Line TRAX train at 1700 South....

Emma Keddington

One person dead after being hit by a TRAX train, bus bridge in place

One person has died after a TRAX incident Monday night.

8 hours ago

Deer Creek Reservoir in Wasatch County pictured....

Emma Keddington

Utah Highway Patrol reports “serious” semitruck rollover at Deer Creek Reservoir

CHARLESTON, Wasatch County — One person is unaccounted for after a semitruck traveling southbound on SR-189 lost control and rolled over into Deer Creek Reservoir Monday night, according to the Utah Highway Patrol.  UHP’s Sgt. Cameron Roden said the semi “lost control and jackknifed… Hit the guard rail and went into Deer Creek Reservoir.”  He […]

9 hours ago

Cass Elliot was a member of the singing group the Mamas & the Papas. After the group broke up, she ...

Jeff Caplan

Jeff Caplan’s Minute of News: Fat shaming is not cool

Fat shaming is completely uncool. But it was not always this way.

9 hours ago

one of chad daybell and tammy daybell's children, daughter Emma Murray takes the stand...

Collin Leonard, KSL.com

Chad Daybell daughter says her mother’s health was declining before she died

Chad Daybell's daughter Emma Murrary took the stand as the defense in the Chad Daybell murder trial began presenting its case Monday.

12 hours ago

a helicopter shown, vertiport demonstration tonight...

Sam Herrera

LISTEN: UDOT and USU to conduct vertiport demonstration

The Utah Department of Transportation and Utah State University will conduct the state's first vertiport demonstration Monday night.

12 hours ago

former president trump shown, hush money trial ongoing...

Sam Herrera

Prosecutors rest case in Trump hush money trial

Prosecutors rested their case on Monday, turning things over to former President Donald Trump's defense team.

13 hours ago

Sponsored Articles

a doctor putting her hand on the chest of her patient...

Intermountain Health

Intermountain nurse-midwives launch new gynecology access clinic

An access clinic launched by Intermountain nurse-midwives provides women with comprehensive gynecology care.

Young couple hugging while a realtor in a suit hands them keys in a new home...

Utah Association of Realtors

Buying a home this spring? Avoid these 5 costly pitfalls

By avoiding these pitfalls when buying a home this spring, you can ensure your investment will be long-lasting and secure.

a person dressed up as a nordic viking in a dragon boat resembling the bear lake monster...

Bear Lake Convention and Visitors Bureau

The Legend of the Bear Lake Monster

The Bear Lake monster has captivated people in the region for centuries, with tales that range from the believable to the bizarre.

...

Live Nation Concerts

All the artists coming to Utah First Credit Union Amphitheatre (formerly USANA Amp) this summer

Summer concerts are more than just entertainment; they’re a celebration of life, love, and connection.

Mother and cute toddler child in a little fancy wooden cottage, reading a book, drinking tea and en...

Visit Bear Lake

How to find the best winter lodging in Bear Lake, Utah

Winter lodging in Bear Lake can be more limited than in the summer, but with some careful planning you can easily book your next winter trip.

Happy family in winter clothing at the ski resort, winter time, watching at mountains in front of t...

Visit Bear Lake

Ski more for less: Affordable ski resorts near Bear Lake, Utah

Plan your perfect ski getaway in Bear Lake this winter, with pristine slopes, affordable tickets, and breathtaking scenery.

FDA advisers move COVID-19 shots closer for kids under 5