Moderna asks the F.D.A. to authorize its vaccine for children under 6
Source: New York Times
Moderna said Thursday that it had asked the Food and Drug Administration to authorize its coronavirus vaccine for children under 6, making it the first manufacturer to do so. A top official said the firm would finish submitting data to regulators by May 9. The development, which was expected, could intensify pressure on federal regulators to authorize a vaccine for the nation’s youngest children. Parents of the roughly 18 million youngest Americans, the only population group not yet eligible for vaccination, have been waiting for months for pediatric doses.
So far, Moderna’s vaccine has been cleared only for adults. The F.D.A. has generally authorized Covid vaccines according to age group, calculating that the risks of severe disease and the benefits of vaccination are highest for the oldest Americans and reduced for young recipients. Moderna has also requested authorization of its Covid vaccine for 6- to 11-year-olds and 12- to 17-year-olds, and a spokeswoman said that it would submit data rounding out those requests in about two weeks.
At a Senate oversight hearing on Tuesday, Dr. Peter Marks, who oversees vaccine regulation for the F.D.A., hinted that the agency might consider Moderna’s applications for everyone under 18 as a whole. Some requests “are complicated because they are relatively larger, covering larger swaths of the pediatric population than others,” he said in response to a senator’s question about when a pediatric vaccine would be ready.
Moderna and Pfizer-BioNTech have both been developing doses for the youngest children since last year. Moderna is proposing a two-dose regimen for children from 6 months to 5 years old, using one-fourth the strength of an adult dose. Pfizer and BioNTech are working on a three-dose regimen for those 6 months to 4 years old, at one-tenth the strength of the adult dose. Pfizer has not yet submitted a request for F.D.A. authorization, but is expected to do so soon.
Read more: https://www.nytimes.com/2022/04/28/us/moderna-fda-vaccine-children-under-6.html
= new reply since forum marked as read
since Omicron hit the youngest children, who are ineligible to be vaxxed, the hardest, and this was the first time this happened to this degree during the 2 year span of the pandemic. 
Jan. 3, 2022, 6:38 PM EST / Updated Jan. 5, 2022, 1:10 PM EST
By Erika Edwards
The number of children hospitalized with Covid-19 is soaring nationwide, especially as the highly transmissible omicron variant of the coronavirus spreads across the country. According to an NBC News analysis, at least nine states have reported record numbers of Covid-related pediatric hospitalizations: Connecticut, Georgia, Illinois, Kentucky, Massachusetts, Maine, Missouri, Ohio and Pennsylvania, as well as Washington, D.C. Some of those children were found to be Covid-positive through routine testing if they had to be hospitalized for other, unrelated issues. But many have been hospitalized specifically because of complications from Covid-19.
The spike in hospitalizations frustrates pediatric infectious disease doctors on the front lines treating children sick with the coronavirus. "It seems like people have tried to downplay the significance of the disease in children," said Dr. Mark Kline, the physician-in-chief at Children's Hospital New Orleans. "We've spent two years rebutting myths pertaining to Covid and children, that it's 'harmless' for children. It's not." As of Monday, Kline said, 14 children were sick enough with Covid-19 to be hospitalized at his facility, and three were in the intensive care unit. The three children are under age 2. The youngest is just 8 weeks old.
At Texas Children's Hospital in Houston, pediatric hospitalization numbers, at close to 70 patients, have surpassed the peak of patients during the surge of the delta variant in the summer, Dr. Jim Versalovic, a pathologist who is a co-leader of the Covid-19 Command Center, said at a news briefing Monday. More than 90 percent of the cases are due to the omicron variant. "More children infected with omicron still translates into a big number of children who may need hospital-based care," Versalovic said.
On Monday, the American Academy of Pediatrics reported a sharp rise in pediatric Covid-19 cases. At least 325,340 cases were reported during the week of Dec. 23, compared with 198,551 cases during the week of Dec. 16. While serious illness from Covid is still rare for younger children, the sheer number of new cases worries doctors. As of Sunday, the number of pediatric Covid admissions had hit a new peak: 1,354 a day, based on a seven-day average, according to NBC News data. And the number of kids who simply occupied hospital beds each day, even if they ultimately weren't admitted to the hospital, reached a record average of 3,081 a day over the last seven-day period.
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https://www.nbcnews.com/health/health-news/covid-warning-symptoms-children-kids-hospitalized-record-numbers-rcna10741
And they had some theories on why -
The huge jump in cases means more hospitalizations. And children’s small airways can be more easily blocked by infections
By Marla Broadfoot on January 25, 2022
Until very recently, if there was one silver lining to the pandemic, it was that kids seemed to escape the worst of the virus. Very few became seriously ill or even mildly sick, compared with adults. But now that hopeful aspect may be fading. The number of children hospitalized with COVID has skyrocketed in recent weeks as the Omicron variant fueled a surge of infections, raising concerns that the latest version of the coronavirus may pose a greater threat to children. Nationwide, an average of 881 children under age 17 are being admitted to hospitals with COVID each day, according to the most recent data from the Centers for Disease Control and Prevention.
Hospitalizations of children under the age of five, who are not eligible for the COVID vaccine, have soared to levels two to four times that of previous peaks. Experts believe the jump in pediatric hospitalizations is likely the result of a confluence of factors. One of them is Omicron’s more contagious nature, and another may be the variant’s newfound preference for airway passages above the lungs, which can be more easily blocked in small children. The big issue is that Omicron is infecting a lot more people.
“We refer to this as the denominator phenomenon,” says Susan Coffin, an infectious disease specialist at Children’s Hospital of Philadelphia. The hospitalization rate is calculated by dividing the number of hospitalizations—the numerator—by the number of known cases—the denominator. If the denominator becomes a bigger number, so will the numerator, the thinking goes. And indeed, a recent report from the American Academy of Pediatrics indicates that the denominator—specifically, the number of pediatric cases—is growing at an enormous rate. Out of the nearly 9.5 million children who have tested positive for COVID-19 since the beginning of the pandemic, nearly 20 percent of these cases occurred in just the first two weeks of January.
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Still, Omicron’s predilection for the respiratory tract above the lungs could spell trouble for the youngest children, whose airways are narrower and less developed. Coffin says it is easier for these tiny airways to be obstructed by mucus and inflammation, causing infants and toddlers to develop wheezing or croup, a disease known for its characteristic barking cough. “These are classic syndromes of childhood, and we are pretty adept at taking care of them,” she says. Though these conditions can land children in the hospital, they are easily treatable, regardless of whether they are caused by SARS-CoV-2 or another virus.
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https://www.scientificamerican.com/article/why-omicron-is-putting-more-kids-in-the-hospital/
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