COVID-19: VACCINE WATCH

Moderna says its COVID shots work for kids under 6, will seek authorization

Mar 23, 2022, 7:26 AM | Updated: 7:47 am
FILE - A health worker administers a dose of a Moderna COVID-19 vaccine during a vaccination clinic...
FILE - A health worker administers a dose of a Moderna COVID-19 vaccine during a vaccination clinic at the Norristown Public Health Center in Norristown, Pa., Tuesday, Dec. 7, 2021. Moderna says its COVID-19 vaccine works in babies, toddlers and preschoolers. The company announced early findings from a study of children younger than 6 on Wednesday, March 23, 2022. (AP Photo/Matt Rourke, File)
(AP Photo/Matt Rourke, File)

Moderna’s COVID-19 vaccine works in babies, toddlers and preschoolers, the company announced Wednesday — and if regulators agree it could mean a chance to finally start vaccinating the littlest kids by summer.

Moderna said in the coming weeks it would ask regulators in the U.S. and Europe to authorize two small-dose shots for youngsters under 6.. The company also is seeking to have larger-dose shots cleared for older children and teens in the U.S.

Early results from the study found that tots developed high levels of virus-fighting antibodies from shots containing a quarter of the dose given to adults — although it was less effective against the super-contagious omicron mutant than prior variants.

“The vaccine provides the same level of protection against COVID in young kids as it does in adults. We think that’s good news,” Dr. Stephen Hoge, Moderna’s president, told The Associated Press.

The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination. Competitor Pfizer currently offers kid-sized doses for school-age children and full-strength shots for those 12 and older.

But parents have anxiously awaited protection for younger tots, disappointed by setbacks and confusion over which shots might work and when. Pfizer is testing even smaller doses for children under 5 but had to add a third shot to its study when two didn’t prove strong enough. Those results are expected by early April.

Vaccinating the littlest “has been somewhat of a moving target over the last couple of months,” Dr. Bill Muller of Northwestern University, an investigator in Moderna’s pediatric studies, said in an interview before the company released its findings. “There’s still, I think, a lingering urgency to try to get that done as soon as possible.”

The younger the child, the smaller the dose being tested. Moderna enrolled about 6,900 kids under 6 — including babies as young as 6 months — in a study of the 25-microgram doses. They developed levels of antibodies just as strong as young adults who get full-strength shots, the company said.

COVID-19 vaccines in general don’t prevent infection with the omicron mutant as well as they fended off earlier variants — although they do still offer strong protection against severe illness.

Moderna’s study in tots was conducted during the omicron surge and found the same trend: While there were no severe illnesses, the vaccine proved just under 44% effective at preventing milder infections in babies up to age 2, and nearly 38% effective in the preschoolers.

But Hoge said high antibody levels still should translate into protection against severe disease in young kids just like they do in adults, “which ultimately is probably the strongest reason for somebody to get vaccinated.”

Moderna said the small doses were safe, and the main side effects were mild fevers like those associated with other commonly used pediatric vaccines.
Booster doses have proved crucial for adults to fight omicron and Moderna currently is testing booster doses for children, either a third shot of the original vaccine or an extra dose that combines protection against the original virus and the omicron variant.

Once Moderna submits the data to the Food and Drug Administration, regulators will debate whether to authorize emergency use of the small doses for tots. If so, the Centers for Disease Control and Prevention then will decide whether to recommend them.

While COVID-19 generally isn’t as dangerous to youngsters as to adults, some do become severely ill. The CDC says about 400 children younger than 5 have died from COVID-19 since the pandemic’s start. The omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge.

Parents may find it confusing that Moderna is seeking to vaccinate the youngest children before it’s cleared to vaccinate teens. While other countries already have allowed Moderna’s shots to be used in children as young as 6, the U.S. has limited its vaccine to adults. A Moderna request to expand its shots to 12- to 17-year-olds has been stalled for months.

The company said Wednesday that, armed with additional evidence, it is updating its FDA application for teen shots and requesting a green light for 6- to 11-year-olds, too.

Hoge said he’s optimistic the company will be able to offer its vaccine “across all age groups in the United States by the summer.”

Moderna says its original adult dose — two 100-microgram shots — is safe and effective in 12- to 17-year-olds. For elementary-age kids, it’s using half the adult dose.

But the FDA never ruled on Moderna’s application for teen shots because of concern about a very rare side effect. Heart inflammation sometimes occurs in teens and young adults, mostly males, after receiving either the Pfizer or Moderna vaccines. Moderna is getting extra scrutiny because its shots are a far higher dose than Pfizer’s.

About 1.5 million adolescents have used the Moderna vaccine in other countries, “and so far we’ve seen very reassuring safety from that experience,” Hoge said.

The heart risk also seems linked to puberty, and regulators in Canada, Europe and elsewhere recently expanded Moderna vaccinations to kids as young as 6.

“That concern has not been seen in the younger children,” said Northwestern’s Muller.
___
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.

COVID-19: Vaccine Watch

Utah national parks no longer have a mask mandate...
Chandler Holt

Masks no longer required in national parks

Since a federal judge struck down the CDC's transportation mask mandate, guests in national parks can choose if they'd like to wear a mask or not.
5 months ago
New eligibility rules for pandemic-EBT program...
Waverly Golden

New eligibility guidelines for Pandemic-EBT

Utah households will have to apply for free or reduced-price meal benefits with their local school by May 6 to possibly receive Pandemic-EBT.
5 months ago
Utah begings using wastewater to track components of the COVID-19 virus in communities...
Dan Bammes

Monitoring COVID-19 virus in Utah through wastewater

SALT LAKE CITY — Utah is monitoring levels of the COVID-19 virus components in sewage at wastewater treatment plants across the state. While it’s a useful early warning system, Utah’s state epidemiologist says it’s just one of the tools they have for monitoring COVID-19 infections in the community. Last year, when the Delta variant showed […]
6 months ago
(A testing site operated by Nomi Health across the street from UDOH headquarters.  Photo: Paul Nels...
Paul Nelson

Federal health officials investigating Utah-based company over COVID-19 testing

A Utah-based company is being investigating for claims of substandard conditions at COVID-19 testing sites.
6 months ago
(A testing site operated by Nomi Health across the street from UDOH headquarters.  Photo: Paul Nels...
Paul Nelson

Health officials will significantly ‘ramp down’ the number of COVID-19 tests they offer

The Utah Department of Health announced it will ramp down the number of COVID-19 tests being offered to the public.
6 months ago
FILE: People wait to check-in at the Qatar Airways counter amid coronavirus fears at Miami Internat...
Aimee Cobabe

Utah joins mask mandate lawsuit against federal government

The lawsuit claims the mask mandate on planes and other public transportation is illegal and prohibitive in states that have banned mask mandates.
6 months ago

Sponsored Articles

Prescription opioid...
Know Your Script

Prescription opioid misuse | How to protect your family from the opioid epidemic

Studies have shown that prescription opioid misuse has increased since COVID-19. So what do you need to know about these opioids?
...

Tax Tuesday: The Most Common Mistakes People Make When Filing Their Taxes

Fortunately, for most average earners, they will not end up owing overpayments received for the Child Tax Credit in 2021.
...

Tax Tuesday: How will last year’s child tax credits affect you?

Fortunately, for most average earners, they will not end up owing overpayments received for the Child Tax Credit in 2021.
...

Tax Tuesday: Key Information Before the Filing Deadline

Businesses can receive a credit of up to $5,000 per employee in 2020 and up to $21,000 per employee in 2021.
national heart month...
Intermountain Healthcare

National Heart Month: 5 Lifestyle Changes to Make Today to Keep You Heart Healthy

Heart disease is the leading cause of death for both men and women. One person dies every 36 seconds in the United States from cardiovascular disease
Joseph Smith Memorial Building...
Temple Square

The Joseph Smith Memorial Building is an icon of Salt Lake City | Why hosting an event at this beautiful location will make you a hero this year

Here's why hosting an event at the iconic Joseph Smith Memorial Building in downtown Salt Lake City will make you a hero this year.
Moderna says its COVID shots work for kids under 6, will seek authorization