Marathon US hearings to decide fate of COVID shots for tots

Jun 9, 2022, 6:35 PM | Updated: Jun 10, 2022, 4:31 pm
This combination of 2022 and 2020 file  photos shows logos for the U.S. Centers for Disease Control...

This combination of 2022 and 2020 file photos shows logos for the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration. On Wednesday, June 15, 2022, both Moderna and Pfizer will have to convince what’s essentially a science court -- advisers to the Food and Drug Administration -- that their shots work well in babies, toddlers and preschoolers. If the FDA’s advisers endorse one or both shots for them -- and the FDA agrees -- there’s still another hurdle. The Centers for Disease Control and Prevention must recommend whether all tots need immunization or just those at high risk from the virus. (AP Photo/Ron Harris, Manuel Balce Ceneta, File)

(AP Photo/Ron Harris, Manuel Balce Ceneta, File)

Parents anxious to finally vaccinate their youngest children against COVID-19, strap in: A lot is set to happen over the next week.

On Wednesday, both Moderna and Pfizer will have to convince what’s essentially a science court — advisers to the Food and Drug Administration — that their shots work well in babies, toddlers and preschoolers.

The FDA weighed in late Friday with its own analysis of Moderna’s vaccine, finding the shots appear safe and effective for children as young as 6 months old. A federal review of Pfizer’s vaccine for the littlest kids is expected by Monday.

Kids under 5 are the only group not yet eligible for COVID-19 vaccination in the U.S. If the FDA’s advisers endorse one or both shots for them — and the FDA agrees — there’s still another hurdle. The Centers for Disease Control and Prevention must recommend whether all tots need immunization or just those at high risk from the virus.

Adding to the complexity, each company is offering different dose sizes and number of shots. And the week won’t even start with the littlest kid debate: Moderna first will ask FDA’s advisers to support its vaccine for older children.

Only a handful of countries, including China and Cuba, have offered different types of COVID-19 vaccinations to children younger than 5.

Here’s a primer to help keep all the developments straight.

PFIZER’S PLAN FOR THE LITTLEST

Pfizer has a pediatric track record — its COVID-19 vaccine is the only type the FDA allows for children of any age. Two doses plus a booster are cleared for everyone 5 and older. Shots for the 5- to 11-year-olds contain a third of the dose given to teens and adults.

For kids younger than 5, Pfizer and its partner BioNTech lowered the dose even more, to a tenth of the adult dose. The trade-off is a need for three shots, the first two given three weeks apart and the last at least two months later.

MODERNA’S PLAN FOR THE LITTLEST

Moderna is seeking FDA clearance for two shots, each a quarter of its adult dose, given about four weeks apart for kids younger than 6. (Moderna tested a slightly different age limit than Pfizer.)

The FDA currently allows Moderna’s vaccine to be used only in adults. But some countries allow two full-size doses for teens and half-size shots for kids ages 6 to 11 — which Moderna also hopes to offer in the U.S.

MAKING THEIR CASE

Pfizer disappointed parents back in December when a study found two shots weren’t quite strong enough. So researchers tested a third shot in youngsters age 6 months through 4 years during the winter surge of the omicron variant.

Pfizer’s preliminary data showed after three shots, children developed high levels of virus-fighting antibodies with no safety problems. In addition, the vaccine appeared 80% effective in preventing symptomatic COVID-19. But that calculation was based on just 10 cases diagnosed among study participants by the end of April, and it could change if more cases have occurred since.

Moderna’s study found tots ages 6 months through 5 years developed high antibody levels after two of its shots. But while there were no severe cases of COVID-19 during the trial, the vaccine was only about 40% to 50% effective at preventing milder infections.

In their review, FDA scientists noted the study was too short to determine how long the vaccine’s effectiveness would last. They also said that it was likely that a booster would be needed, based on the experience with adults.

Moderna recently added a booster dose to the tot study — and disclosed in a presentation for Wednesday’s meeting that it also plans to allow participants a chance to help test an omicron-targeting booster.

WHEN COULD SHOTS START?

If the FDA authorizes one or both shots — a decision expected shortly after its advisory panel’s meeting — all eyes move to the CDC. That agency recommends how to use vaccines. Which tots should get COVID-19 vaccination will be an important debate as the coronavirus doesn’t tend to make children as sick as adults yet nearly 500 deaths in U.S. children under 5 have been reported.

The CDC’s own vaccine advisers are scheduled to meet next Friday and Saturday, and a final decision by the CDC’s director, Dr. Rochelle Walensky, should come shortly after they’re done.

If all those steps fall into place, vaccinations could begin in many areas June 21.

VACCINATION SITES

Pediatricians, other primary care physicians and children’s hospitals are expected to vaccinate most of the youngest kids. Limited drugstores will offer them for at least some of the under-5 group — parents should check local availability for different ages. The Biden administration says it also is working with a variety of other groups, such as children’s museums, to offer pop-up clinics and reach even more youngsters.

WHAT IF MY CHILD RECENTLY HAD COVID-19?

About three-quarters of children of all ages are estimated to have been infected at some point during the pandemic. It’s a question sure to come up as CDC’s advisers make recommendations for the littlest kids, so stay tuned.

For older ages, the CDC has recommended vaccination anyway to lower the chances of reinfection. There’s no firm guidance on how long to wait; the CDC has said people may wait as long as three months.

DEMAND IS UNCLEAR

There are roughly 18 million children younger than 5, and many parents are eager to get their tots vaccinated. But it’s unclear how many ultimately will, given disappointing vaccine uptake by older children.

According to the CDC, just 29% of kids ages 5 to 11 have gotten two doses, and about 60% of 12- to 17-year-olds.

WHAT ABOUT MODERNA AND OLDER KIDS?

On Tuesday, the FDA’s advisers will consider Moderna shots for older kids, those 6 to 17 — a decision that might alleviate some parent confusion. The FDA review released Friday also included an analysis of the company’s shots for that age group.

The FDA has held up Moderna’s teen vaccine for months while it investigated a rare side effect, heart inflammation. That’s mostly a risk for teen boys and young men, and also can occur with the Pfizer vaccine. The FDA review said its latest analysis of reports of myocarditis both in the U.S. and in other countries did not find conclusive evidence of a difference in risk between the Moderna and Pfizer vaccines.

___

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.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

AP

FILE - President Joe Biden speaks on the White House campus, June 17, 2022, in Washington. The Bide...
Associated Press

Biden aims at China in new illegal fishing policy framework

The Biden administration is stepping up efforts to combat illegal fishing by China, ordering federal agencies to better coordinate among themselves as well as with foreign partners in a bid to promote sustainable exploitation of the world's oceans.
20 hours ago
A technician monitors the self-driving taxi developed by tech giant Baidu Inc. on June 14, 2022, in...
Associated Press

China’s Baidu races Waymo, GM to develop self-driving cars

BEIJING (AP) — With no one at the wheel, a self-driving taxi developed by tech giant Baidu Inc. is rolling down a Beijing street when its sensors spot the corner of a delivery cart jutting into its lane. The taxi stops a half-car-length away. “So sorry,” a recorded voice tells passengers. The steering wheel turns […]
20 hours ago
Associated Press

Puerto Rico police uncover island’s biggest pot greenhouse

SAN JUAN, Puerto Rico (AP) — Puerto Rico police said they raided the island’s largest hydroponic marijuana greenhouse on Tuesday, with nearly 2,000 plants being grown in a former addiction treatment center. Police Commissioner Antonio López Figueroa said officers discovered the greenhouse in the northern town of Carolina, just east of the capital of San […]
20 hours ago
Associated Press

Ratings show Fox News viewers tuning out Jan. 6 hearings

NEW YORK (AP) — Fox News Channel is airing the Jan. 6 committee hearings when they occur in daytime hours and a striking number of the network’s viewers have made clear they’d rather be doing something else. During two daytime hearings last week, Fox averaged 727,000 viewers, the Nielsen company said. That compares to the […]
20 hours ago
Associated Press

California budget won’t cover out-of-state abortion travel

SACRAMENTO, Calif. (AP) — While Gov. Gavin Newsom has pledged to make California a sanctuary for women seeking abortions, his administration won’t spend public money to help people from other states travel to California for the procedure. Newsom’s decision, included in a budget agreement reached over the weekend, surprised abortion advocates who have been working […]
20 hours ago
Associated Press

2 workers presumed dead after trench collapse in Texas

JARRELL, Texas (AP) — Two workers were presumed dead after a trench they were digging for a sewer line in Texas on Tuesday collapsed and buried them, officials said. The workers were digging a 24-foot-deep (7-meter-deep) in new subdivision under development in Jarrell, about 40 miles (65 kilometers) north of Austin, when it caved in […]
20 hours ago

Sponsored Articles

Swedish Cyberknife 900x506...

June is Men’s Health Month: Here’s Why It’s Important To Speak About Your Health

According to the Centers for Disease Control and Prevention, men in the United States, on average, die five years earlier than women.
...

Anacortes – A Must Visit Summertime Destination

While Anacortes is certainly on the way to the San Juan Islands (SJI), it is not just a destination to get to the ferry… Anacortes is a destination in and of itself!
...

Ready for your 2022 Alaskan Adventure with Celebrity Cruises?

Celebrity Cruises SPONSORED — A round-trip Alaska cruise from Seattle is an amazing treat for you and a loved one. Not only are you able to see and explore some of the most incredible and visually appealing natural sights on the planet, but you’re also able to relax and re-energize while aboard a luxury cruise […]
...

Compassion International Is Determined to ‘Fill’ a Unique Type of Football ‘Stadium’

Compassion International SPONSORED — During this fall’s football season—and as the pandemic continues to impact the entire globe—one organization has been urging caring individuals to help it “fill” a unique type of “stadium” in order to make a lasting difference in the lives of many. Compassion International’s distinctive Fill the Stadium (FtS, fillthestadium.com) initiative provides […]
...

What are the Strongest, Greenest, Best Windows?

Lake Washington Windows & Doors SPONSORED — Fiberglass windows are an excellent choice for window replacement due to their fundamental strength and durability. There is no other type of window that lasts as long as fiberglass; so why go with anything else? Fiberglass windows are 8x stronger than vinyl, lower maintenance than wood, more thermally […]
...

COVID Vaccine is a Game-Changer for Keeping our Kids Healthy

Snohomish Health District SPONSORED — Cheers to the parents and guardians who keep their kids safe and healthy. The dad who cooks a meal with something green in it, even though he’s tired and drive-thru burgers were tempting. The mom who calms down the little one who loudly and resolutely does NOT want to brush […]
Marathon US hearings to decide fate of COVID shots for tots