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.
“There is an important unmet medical need here with these youngest kids,” Dr.
That effectiveness is “less than optimal. We were hoping for better efficacy but this is a first step,” said Dr.
“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
Whether it’s one company’s shots or both, FDA vaccine chief Dr.
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
“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
If FDA clears vaccinations for the littlest, next the
“It's very important to get the youngest children vaccinated” but “moving quickly doesn't mean moving sloppily,” said Dr.
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
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
“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
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.
Another issue: So far in the
It's not clear if FDA will consider
Burton said safety data from millions of older children given
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
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
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