More than 1 in 4 Akron Children’s PICU patients have COVID-19

Akron Children’s Hospital is treating a record number of hospitalized COVID-19 patients, who now account for more than a quarter of all patients in the pediatric intensive care unit.

As of Tuesday, Akron Children’s has 20 COVID-19 patients hospitalized, including 17 in Akron and three at its Beeghly Campus in Boardman, which is a new single-day high number for Children’s, said Dr. Robert McGregor, chief medical officer for Akron Children’s.

McGregor said 28% of the patients in its pediatric intensive care unit are COVID-19 patients.

The Beacon Journal has been tracking the number of COVID-19 patients in Summit County hospitals on weekdays since Nov. 30, 2020, and also received COVID-19 patient data for Akron Children’s for weekdays from April 7 through Nov. 27, 2020.

The numbers were either zero or in the single digits from April 7, 2020, until Dec. 15, 2020, when Children’s reported 11 COVID-19 patients. That also was the date of the highest number of hospitalized COVID-19 patients reported countywide — 318 total — at Children’s, Summa Health, Cleveland Clinic Akron General and Western Reserve Hospital in Cuyahoga Falls.

Children’s reported 10 patients on Dec. 16, but starting Dec. 17, it dropped back into single digits again, staying there until the beginning of January. Throughout January, the numbers fluctuated between single and double-digits, hitting a January high of 13 on Jan. 11 and Jan. 22.

But the number again dropped into the single digits on Jan. 25, and except for 10 reported on Feb. 5, the number stayed in the single digits or was zero until Sept. 1, when the hospital reported 12 COVID-19 patients. The number has been in the double digits for most of September.

According to the American Academy of Pediatrics and the Children’s Hospital Association, as of Sept. 16, more than 5.5 million children have tested positive for COVID-19 since the beginning of the pandemic.

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The groups said nearly 226,000 cases were added the past week, the third highest number of child cases in a week since the pandemic began. After declining in early summer, the groups said child cases have increased exponentially, with more than 925,000 cases in the past four weeks.

Since the pandemic began, the groups said children represented 15.7% of total cumulated cases, and for the week ending Sept. 16, children were 25.7% of reported weekly COVID-19 cases. Children 17 and younger make up 22.2% of the U.S. population.

Pfizer says vaccine safe, effective for kids 5 to 11

The increase in hospitalized pediatric cases during the surge of the delta variant comes as Pfizer and German partner BioNTech released data from a clinical trial Monday showing that its vaccine is safe and effective for children ages 5 to 11 at one-third of the dose given to adolescents and adults.

The study of 2,268 volunteers ages 5 to 11 showed they mounted the same type of strong immune response to the vaccine as teens and young adults. Because Comirnaty, the vaccine's brand name, has already proven effective in older groups, the companies only had to show that the vaccine led to a similar immune response in children — rather than prove it prevented COVID-19 infections. That's why this study was allowed to be conducted with fewer than the 44,000-person trial in adults.

The adult dose of the Pfizer-BioNTech vaccine is 30 micrograms, while the companies propose a 10-microgram dose in children ages 5 to 11. As in adults, the vaccine would be given to children in two shots, delivered at least three weeks apart.

At this lower dose, Pfizer says the vaccine is safe for children. But full safety data won’t be available to the public until it’s officially reviewed by the FDA, health experts say.

According to the new research, children experienced the same types of mostly minor side effects seen in adolescents and young adults. The most common side effects seen in adults include pain or swelling at the injection site, headache, chills, muscle aches, fatigue and fever.

'We've got a vaccine dose that's safe for kids'

Dr. Michael Bigham, chief quality officer at Akron Children's Hospital and a pediatric intensive care physician, said in a Facebook video that he knows parents and caregivers have been “sort of waiting anxiously for the results of those younger age group studies and what that might mean for you vaccinating your child or the child you care for."

Bigham said there are two big takeaways from the study: It shows the vaccine works in the younger age group, and children in that age group are given a lower dose of the vaccine than adults.

“And so we now know we've got a vaccine dose that's safe for kids, and we also know we have a vaccine response that's robust for those kids,” he said. “And so we know these youngsters have been wearing masks, they've been keeping their distance, they've been doing good hand hygiene, and they've really, many of these kids and many of us who care for those kids have been waiting for an alternative or additional solution to protect the health of those children. And we're excited about the prospects of this Pfizer study."

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Bigham said if and when the vaccine is approved to be given in children 5 to 11, Akron Children’s will be involved in administering the shots.

But Bigham cautioned that it will take time to get that age group vaccinated.

“Now I'm gonna caution everybody that the day it's approved, we won't be able to vaccinate everybody that wants to be vaccinated. That's just not mathematically possible,” he said. “But just know that we will have an all-hands-on-deck approach to get as many kiddos vaccinated as quickly as we can in that 5 to 11 age group when that approval is granted.”

Although some trial data is now available to the public, a formal application with detailed data must be submitted to the FDA so the vaccine can be considered for emergency use authorization.

Pfizer intends to submit this data by the end of the month, Dr. Bill Gruber, the company’s senior vice president of vaccine clinical research and development, said in an interview with NBC News’ TODAY.

Health experts say submitting a formal emergency use authorization application is a longer process than revealing initial data because of how much paperwork it involves. But once the data is submitted, the FDA and the Centers for Disease Control and Prevention will need to sign off on the vaccine before it becomes available to children.

Authorization is likely to come within "a matter of weeks not months” of submission, the FDA's Dr. Peter Marks told USA TODAY recently.

The companies are also studying their vaccine in children ages 2 to 5, and 6 months to age 2, but those trials are not yet complete. Younger children are being tested on a 3- microgram dose.

Pfizer has reported it may have data by the end of the year. Before the vaccine becomes available to young children and infants, the company will have to submit the data for FDA and CDC review.

USA TODAY contributed to this article. Contact Beacon Journal reporter Emily Mills at emills@thebeaconjournal.com and on Twitter @EmilyMills818.