Saturday May 21st, 2022 9:12AM

Moderna seeks to be 1st with COVID shots for littlest kids

By The Associated Press
Related Articles
  Contact Editor

Moderna is seeking to be the first to offer COVID-19 vaccine for the youngest American children, as it asked the Food and Drug Administration Thursday to clear low-dose shots for babies, toddlers and preschoolers.

Frustrated families are waiting impatiently for a chance to protect the nation’s littlest kids as all around them people shed masks and other public health precautions -- even though highly contagious coronavirus mutants continue to spread. Already about three-quarters of children of all ages show signs they've been infected at some point during the pandemic.

Moderna submitted data to the Food and Drug Administration that it hopes will prove two low-dose shots can protect children younger than 6 -- although the effectiveness wasn't nearly as high in kids tested during the omicron surge as earlier in the pandemic.

“There is an important unmet medical need here with these youngest kids,” Dr. Paul Burton, Moderna's chief medical officer, told The Associated Press. Two kid-size shots “will safely protect them. I think it is likely that over time they will need additional doses. But we're working on that.”

Moderna said two kid doses were about 40% to 50% effective at preventing symptomatic COVID-19, not a home run but for many parents, any protection would be better than none.

That effectiveness is “less than optimal. We were hoping for better efficacy but this is a first step,” said Dr. Nimmi Rajagopal of Cook County Health in Chicago. She’s anxiously awaiting vaccinations for her youngest patients and her own 3-year-old son who’s ready to enter preschool.

“It gives me such peace of mind to know that hopefully by fall I’ll get him in school and he’ll be fully vaccinated,” she said.

Now, only children ages 5 or older can be vaccinated in the U.S., using rival Pfizer’s vaccine, leaving 18 million younger tots unprotected.

Moderna's vaccine isn't the only one in the race. Pfizer is soon expected to announce if three of its even smaller-dose shots work for the littlest kids, months after the disappointing discovery that two doses weren’t quite strong enough.

Whether it’s one company’s shots or both, FDA vaccine chief Dr. Peter Marks said the agency will “move quickly without sacrificing our standards” in deciding if tot-sized doses are safe and effective.

While questions are swirling about what's taking so long, Marks pointedly told lawmakers earlier this week that the FDA can't evaluate a product until a manufacturer completes its application. In a statement Thursday, the FDA said it will schedule a meeting to publicly debate Moderna's evidence with its independent scientific advisers but that the company still must submit some additional data. Moderna expects to do so next week.

“It’s critically important that we have the proper evaluation so that parents will have trust in any vaccines that we authorize,” Marks told a Senate committee.

If FDA clears vaccinations for the littlest, next the Centers for Disease Control and Prevention would have to recommend who needs them -- all tots or just those at higher risk from COVID-19.

“It's very important to get the youngest children vaccinated” but “moving quickly doesn't mean moving sloppily,” said Dr. Philip Landrigan, a pediatrician and public health expert at Boston College. FDA must "see if it’s safe. They need to see if it’s effective. And they need to do so swiftly. But they won’t cut corners.”

Many parents are desperate for whichever vaccine gets to the scientific finish line first.

“We’ve been kind of left behind as everybody else moves on,” said Meagan Dunphy-Daly, a Duke University marine biologist whose 6-year-old daughter is vaccinated -- but whose 3-year-old and 18-month-old sons are part of Pfizer’s trial.

The family continues to mask and take other precautions until it’s clear if the boys got real vaccine or dummy shots. If it turns out they weren't protected in the Pfizer study and Moderna's shots are cleared first, Dunphy-Daly said she'd seek them for her sons.

“I will feel such a sense of relief when I know my boys are vaccinated and that the risk of them getting a serious infection is so low,” she said.

The FDA will face some complex questions.

In a study of 6,700 kids ages 6 months through 5 years, two Moderna shots — each a quarter of the regular dose — triggered high levels of virus-fighting antibodies, the same amount proven to protect young adults, Burton said. There were no serious side effects, and the shots triggered fewer high fevers than other routine vaccinations.

But depending on how researchers measured, the vaccine proved at best about 51% effective at preventing COVID-19 cases in babies and toddlers and about 37% effective in the 2- to 5-year-olds. Burton blamed the omicron variant's ability to partially evade vaccine immunity, noting that unboosted adults showed similarly less effectiveness against milder omicron infections. While no children became severely ill during the study, he said high antibody levels are a proxy for protection against more serious illness — and the company will test a child booster dose.

“That's not totally out of the realm of what we would have expected,” said Dr. Bill Muller of Northwestern University, who helped with Moderna's child studies. “Down the road I would anticipate it's going to be a three-shot series.”

Another issue: So far in the U.S., Moderna's vaccine is restricted to adults. Other countries have expanded the shot to kids as young as 6. But while Moderna has filed FDA applications for older kids, too, the FDA hasn't ruled on them. Months ago the agency cited concern about a rare side effect, heart inflammation, in teen boys, a concern that hasn't been reported in much younger children.

It's not clear if FDA will consider Moderna's vaccine for children of all ages now or focus first on the littlest. But Muller already has had lots of parents ask why shots were being tested in tots before older kids were vaccinated — and says pediatricians and pharmacists must be ready with answers.

Burton said safety data from millions of older children given Moderna vaccinations abroad should help reassure parents.

While COVID-19 generally isn’t as dangerous in youngsters as adults, some do become severely ill or even die. About 475 children younger than 5 have died from COVID-19 since the pandemic’s start, according to the CDC, and child hospitalizations soared at omicron's peak.

Yet it’s not clear how many parents intend to vaccinate the youngest kids. Less than a third of children ages 5 to 11 have had two vaccinations, and 58% of those ages 12 to 17.


AP journalists Matthew Perrone and Lindsey Tanner contributed to this report.


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.

  • Associated Categories: U.S. News, Associated Press (AP), AP National News, AP Online National News, Top U.S. News short headlines, Top General short headlines, AP Health, AP Health - Children's Health, AP Business
© Copyright 2022 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
Moderna seeks to be 1st with COVID shots for littlest kids
Moderna is asking U.S. regulators to open its COVID-19 vaccine to the nation's youngest children
7:17AM ( 3 minutes ago )
McDonald's Q1 sales up despite struggles in China and Russia
McDonald’s said higher U.S. menu prices and easing COVID restrictions elsewhere helped offset troubled markets like China and Russia in the first quarter
7:04AM ( 16 minutes ago )
Ukraine says Russian offensive in east picks up momentum
Ukraine says that Russia’s offensive in the east has picked up momentum, with several towns coming under intense attack as Moscow’s forces attempt to surround Ukrainian troops
6:20AM ( 59 minutes ago )
Associated Press (AP)
Most in US fear Ukraine war misinformation: AP-NORC poll
A majority of U.S. adults say misinformation around Russia’s invasion of Ukraine is a major problem, and they largely fault the Russian government for spreading those falsehoods
5:32AM ( 1 hour ago )
Israel halts for Holocaust day, honors 6 million Jews killed
Israel has come to a halt to honor the 6 million Jews killed in the Holocaust
5:06AM ( 2 hours ago )
European leaders blast cutoff of Russian gas as 'blackmail'
European leaders blasted Russia’s decision to cut natural gas shipments to Poland and Bulgaria as “blackmail.”
4:09AM ( 3 hours ago )
AP National News
Millionaire candidates pour cash into Ohio, Pa. Senate races
Millionaire candidates and billionaire investors are harnessing their considerable personal wealth to try to win competitive Republican primaries for open U.S. Senate seats in Pennsylvania and Ohio
12:07AM ( 7 hours ago )
Dem lawmaker: Biden suggests he'll ease student loan burden
President Joe Biden has signaled he might forgive some student loan debt and further extend the federal moratorium on repayments
12:05AM ( 7 hours ago )
State report details bias in Minneapolis Police Department
A Minnesota state agency says it will work with the city of Minneapolis to negotiate solutions to resolve the pattern of race discrimination uncovered by a two-year investigation
11:34PM ( 7 hours ago )
Top General short headlines
New tests to decide Shanghai reopening as Beijing stocks up
Shanghai city authorities say a taxing, one-month lockdown of China’s largest city may be eased in some neighborhoods if new COVID-19 testing shows the virus is no longer spreading in the community
9:54PM ( 9 hours ago )
Lawmakers scrutinize McKinsey's opioid, FDA consulting work
Lawmakers vowed to continue investigating consulting firm McKinsey after a hearing scrutinizing its work for the Food and Drug Administration even as it advised opioid makers on boosting sales
5:24PM ( 13 hours ago )
Latin American nations ease restrictions as COVID cases drop
Plummeting coronavirus infection rates across Latin America have led governments in the region to lift restrictions on mass gatherings, travel requirements and mask mandates that have been in place for two years
4:36PM ( 14 hours ago )
AP Health
COVID shots still work but researchers hunt new improvements
COVID-19 vaccines still offer strong protection against severe illness and death, but Moderna and Pfizer are testing combination shots as a possible new kind of booster
8:55AM ( 3 days ago )
Rates for measles, other vaccinations dip for kindergartners
The portion of U.S. children getting routine vaccinations required for kindergarten dipped slightly during the pandemic
1:11PM ( 6 days ago )
EXPLAINER: What medical treatments do transgender youth get?
Transgender medical treatment for children and teens is under attack in many states, but it has been available for more than a decade and is endorsed by major medical associations
10:00AM ( 6 days ago )
AP Health - Children's Health
Live Updates | UN chief tours damaged areas outside Kyiv
United Nations Secretary-General Antonio Guterres has toured areas outside the Ukrainian capital that suffered damage during the Russian advance there
5:33AM ( 1 hour ago )
Live Updates | German lawmakers back heavy weapons for Kyiv
German lawmakers have voted in favor of sending heavy weapons to Ukraine, a symbolic decision that reflects the government’s change of course on the issue
5:11AM ( 2 hours ago )
Huawei's Q1 sales down 14% as U.S. sanctions remain
Chinese telecoms equipment and smartphone maker Huawei has reported its sales fell 14% in the last quarter from a year earlier, as the company continued to pump money into research and development while grappling with U.S. sanctions
4:56AM ( 2 hours ago )
AP Business
McDonald's Q1 sales up despite struggles in China and Russia
McDonald’s said higher U.S. menu prices and easing COVID restrictions elsewhere helped offset troubled markets like China and Russia in the first quarter
7:04AM ( 16 minutes ago )
Ukraine says Russian offensive in east picks up momentum
Ukraine says that Russia’s offensive in the east has picked up momentum, with several towns coming under intense attack as Moscow’s forces attempt to surround Ukrainian troops
6:20AM ( 1 hour ago )
Taiwan faces largest COVID-19 outbreak yet
Taiwan had been living mostly free of COVID-19 until this month
6:20AM ( 1 hour ago )
NATO chief says Finland, Sweden could join quite quickly
NATO Secretary-General Jens Stoltenberg says that Finland and Sweden would be embraced with open arms should they decide to join the 30-nation military organization and could become members quite quickly
6:17AM ( 1 hour ago )
Live Updates | Mariupol council warns on conditions in city
Mariupol authorities are sounding the alarm about unsanitary conditions in the ravaged port city that they say pose a “deadly danger” to its remaining residents
6:04AM ( 1 hour ago )