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Children younger than age 5 are the largest group of people not yet eligible for COVID-19 vaccines, and it may be several months into the new year before the U.S. Food and Drug Administration authorizes their use.
Meanwhile, the national Centers for Disease Control and Prevention authorized booster shots for children ages 12-15 in early January.
On Friday, the agency released a separate report that shows the Pfizer vaccine is “highly effective” in preventing multisystem inflammatory syndrome in children ages 12-17. MIS-C is a rare condition that arises after a child contracts COVID-19, causing inflammation in a variety of internal organs.
Of 102 children diagnosed with MIS-C, 97 of them were unvaccinated, and of those, 38 required life support during their hospital stay.
But this still leaves a large portion of the population unvaccinated.
A smaller dose of the Moderna vaccine is being tested for children ages 6 months and older. One of those test sites is in Madison, Wis. So far, the trial is going “quite well,” said Dr. Bill Hartman, principal investigator for the Moderna KidCOVE trial at University of Wisconsin-Madison.
“They are more than just little adults,” he said of small children. “Their bodies, their systems, work a little bit different. We have to find the optimal dose.”
It is a double-blind study, which means both patients and those administering the shots don’t know if the vaccine or placebo is used. So far, children have not had any “unusual side effects” to getting the vaccine.
If all goes well with the rest of the Moderna trial, Hartman said he anticipates the Food and Drug Administration could authorize a vaccine under emergency use authorization in late March or early April.
While parents may be anguished over the long wait time, Hartman said it should give parents confidence the vaccine is safe.
“It does take time to do these studies right,” Hartman said. “And it takes time to make sure that we are putting out a safe and effective product, so when it goes into the arms of kids, there’s nothing better out there.
“You only get one chance to make it right, and we look at everything and do everything we can to make sure it’s done correctly.”
Pfizer officials had hoped to submit trial data by the end of 2021 to request emergency use authorization for those 5 and younger, but the Pfizer two-dose regimen for children ages 2-4 did not trigger an immune response like that of teenagers and adults, though it did for children 6 months to 2 years old, according to a Pfizer press release in December.
Pfizer will continue the clinical trial to see whether a third dose improves immune response. A longer clinical trial means it could take months longer for a vaccine for young children to come to market.
Dr. Anthony Fauci, chief medical adviser to the president, confirmed a vaccine for young ones could take many months to develop in his remarks to the National Press Club in December. We should be prepared to live with the coronavirus for the rest of our lives, he said.
In all of human history, only one virus has been eliminated, and that’s smallpox, Fauci said.
“We are never going to eliminate this virus,” Fauci said of COVID-19.
We had a chance to stem the tide of deaths and serious illness, but that chance evaporated in early 2021, Fauci said.
“You have 50 million people who refuse to get vaccinated, many of whom are fueled by political ideology,” Fauci said. “Hospitals are full of people who made that mistake, and so are graveyards.”
In North Carolina
Before the holidays, Dr. Mandy Cohen, then-secretary of the N.C. Department of Health and Human Service, and Gov. Roy Cooper urged North Carolinians to get their booster shots of the COVID vaccine. Cohen predicted daily positive cases could eclipse 10,000 per day by mid-January, with evidence suggesting the omicron variant was two or three times as infectious as delta, and four to six times as infectious as the original COVID-19 strain.
However, the omicron variant quickly became the dominant COVID strain worldwide, even before the new year. North Carolina was no exception.
On Dec. 21, North Carolina saw 2,894 newly reported cases of COVID and a 10% positivity rate. On Dec. 31, more than 1-in-4 people tested positive, with 19,174 new cases of COVID. Both figures have skyrocketed since then.
On Friday, the state reported nearly 1-in-3 people tested were positive for COVID-19, for a total of 28,474 new cases. Hospitalizations reached a level not seen since September, with nearly 3,500 people hospitalized throughout the state.
Once a vaccine does become available for young children, Fauci urged parents to take advantage of it. After all, most children are vaccinated against diseases that kill fewer people than COVID does, he said.
Child cases increased 64% from the beginning of December and had reached the highest case count ever, according to a December presentation by the American Academy of Pediatrics and the Children’s Hospital Association. This was also prior to the wide spread of the omicron variant.
Though child deaths are relatively rare, 38 children ages birth to 17 years died in the United States in the week ending Dec. 16 — the most child deaths of COVID since the pandemic began, the presentation stated.