Cases of children with covid-19 increase in the US 0:59
(CNN) -
Dr. Bud Weidermann runs one of the US pediatric trial sites for a COVID-19 vaccine.
The question that arises from parents now is not about the vaccine itself, but rather, what exactly is taking so long?
Anxious parents want to vaccinate young children and want to do it now.
But no vaccine is licensed for people under the age of 12.
There is a waiting list of 2,000 people to enter Wiedermann's covid-19 vaccine trial at the National Children's Hospital, where he works as an infectious disease specialist.
"I certainly understand where [people's anxiety] is coming from. I think we're dealing with the delta variant, which is a different ball game than we've had before with covid-19 and school is just around the corner. "Wiedermann said.
"So things are starting to look up. And parents and kids are getting anxious about it."
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Concern about covid cases in children
Parents, doctors, and even President Joe Biden have expressed concern about the growing number of children contracting COVID-19.
Children have largely been spared the worst of COVID-19 - hospitalizations and deaths are still rare - but cases have risen and, without a vaccine, they remain vulnerable.
Pediatricians say the Food and Drug Administration (FDA) must act faster.
The American Academy of Pediatrics (AAP) understands parental anxiety and impatience.
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AAP President Dr. Lee Savio Beers said there should be more urgency surrounding the authorization of the Covid-19 vaccine for young children in the United States.
"It's really important to make sure we get closer to licensing the covid vaccine for our youngest children, just as urgently as we did for adults," Beers told CNN's Wolf Blitzer on Tuesday.
"It really is a very urgent situation."
Claim to FDA for children's vaccine
Beers' organization wrote a letter to FDA Acting Commissioner Dr. Janet Woodcock last week urging the Administration not to delay authorization.
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Last month, the FDA asked Pfizer and Moderna to double the number of children ages 5 to 11 in clinical trials.
However, the FDA also requested six months of follow-up safety data, rather than the two months it requested with adults.
"While we appreciate this prudent step to collect more safety data, we urge the FDA to carefully consider the impact of this decision on the schedule to authorize a vaccine for this age group," the letter read.
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The AAP argued that the FDA should authorize vaccines for children ages 5 to 11 based on data from the initial trial already available.
Two months of safety data should also be sufficient, he said.
"Waiting for a 6-month follow-up will significantly hamper the ability to reduce the spread of the hyper-infectious delta variant of covid-19," the letter read.
Slight risks of heart inflammation
Vaccine advisers at the U.S. Centers for Disease Control and Prevention (CDC) said in June that there is a likely association between mRNA vaccines against covid-19. 19 and extremely rare cases of heart inflammation in adolescents and young adults.
But that the benefits of vaccination still clearly outweigh the risks.
The cases of inflammation appeared to be mild and resolved quickly on their own or with minimal treatment.
"There is no biological plausibility that serious adverse immunological or inflammatory events will occur more than two months after the administration of the COVID-19 vaccine," the letter said.
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US Chief Health Officer Dr. Vivek Murthy said Wednesday that the FDA "will act quickly" to evaluate the vaccine companies' data once it is ready.
And a COVID-19 vaccine may be available for children under the age of 12 before the end of 2021.
"If everything went well and everything fell into place, I think we may be able to see a vaccine before the end of the calendar year for children under 12," Murthy told CNN's Wolf Blitzer.
"Make no mistake, the FDA will act quickly on this because it recognizes what is at stake. It is the health of our children, and there really is nothing more important than that."
Without the 'luxury' of time for additional data
Still, Dr. Yvonne Maldonado, Stanford Professor of Pediatric Infectious Diseases, who served on the AAP committee that helped draft the letter, is concerned that the FDA is unnecessarily delaying authorization.
"We don't have the luxury of being able to sit back and wait for additional data like this to come in," said Maldonado, who is also a principal investigator at the Stanford site of the Pfizer-BioNTech pediatric vaccine trial.
"We have to make some decisions based on best practices."
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Maldonado worries that the FDA is listening too carefully to its critics.
"We can't stop now because people are doubting what the FDA is doing," Maldonado said.
Dr. Paul Offit, a member of the FDA's vaccine advisory committee, said he cannot understand why the FDA requested more data.
"Longer follow-up for security reasons doesn't make sense. You really only need two months," Offit said.
You hope your committee receives data from the trials for review soon.
"I'm frustrated," Offit said.
"As we move into the fall [boreal], this puts children at greater risk."
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Slow and cautious step process
Dr. Bill Mueller, who has been working on Moderna's pediatric trials, believes that some parts of the trial process have been too slow.
But he is in favor of additional data.
"We have to be very cautious about expanding authorization to a really large patient population," said Mueller, scientific director of Clinical and Community Trials at the Stanley Manne Children's Research Institute.
"That doesn't mean we should be overly cautious," said Mueller, who is also an assistant physician in Pediatric Infectious Diseases at Ann & Robert H. Lurie Children's Hospital in Chicago.
"It's really going to be a question of balance."
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Delta variant and increased cases in children
With the most contagious delta variant, COVID-19 cases among children have been on the rise since early July, after months of decline.
Nearly 94,000 cases among children were added last week, the American Academy of Pediatrics said in what the group described as a "continued substantial increase."
The vast majority of children don't end up in the hospital.
But, as of Saturday, the number of children who were recently hospitalized saw a 21% increase week over week, according to the CDC.
Why are children's essays necessary?
Before a vaccine can be tested in children, scientists test it in adults.
"It's to protect children and protect their safety and well-being," said Dr. Daniel B. Blatt of Norton Children's and the University of Louisville School of Medicine, who has been working on pediatric trials of the Pfizer vaccine. .
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Researchers typically use what's called an age reduction model, he said.
Scientists start with adults, and once they see that it is safe to do so, they move the study over to older children and then younger ones.
It is a time-consuming process, but it is necessary.
While COVID-19 vaccines have been shown to be safe and protective in millions of people, scientists can't just extrapolate it to younger children.
"Children are not just miniature adults, their immune systems are different," said Dr. Katherine Luzuriaga, professor of Molecular Medicine, Pediatrics and Medicine at the UMass School of Medicine, who is working on Moderna's pediatric trial. .
"The way they respond can sometimes be different."
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In one trial, scientists begin the research by essentially making their best guess as to what dose would be safe and would elicit an immune response to protect the child from contracting COVID-19.
"It's that kind of 'Goldilocks' approach that's not too big and not too small," Luzuriaga said.
Along the way, there is an evaluation of the data to make sure there are no concerns about product safety.
Vaccination schedule for younger children
"I think by the end of the [boreal] fall, we will have, if all goes well, hopefully enough information and data to support us in that age group," Luzuriaga said.
The data for children ages 5 to 11 could arrive sometime in September, depending on the findings.
Pfizer told CNN it could ask the FDA to authorize the vaccine later that month.
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Data for 2- to 5-year-olds could come in shortly thereafter.
For younger children, Pfizer said it could potentially get data in October or November.
And soon after, he would ask the FDA to authorize emergency use.
Emergency use considerations by the FDA can take several weeks, meaning that a vaccine for younger children will likely not be available until late fall or even next year.
"I think we are getting closer"
Pediatricians never feel like things are moving fast enough, especially when they have a patient sitting across from them who needs something, Luzuriaga said, but the research takes time.
"I think we are getting closer," Luzuriaga said.
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Moderna told CNN that it expects data later this year or towards early 2022. There may also be interim data at various stages of the test, but that timeline is difficult to predict.
Johnson & Johnson told CNN it has used its small trial of 16- and 17-year-olds from the beginning of the year to design four late-stage studies for younger children.
And that the company is in "active discussions with regulatory authorities regarding our development, drawings and test designs."
The company anticipates that those trials will begin in the fall of the Northern Hemisphere.
"To keep children safe and ultimately achieve herd immunity, it is imperative that clinical trials of the COVID-19 vaccine continue to advance in this population. And we remain deeply committed to the critical work necessary to make that our covid-19 vaccine is equitably accessible to all age groups, "a J&J spokesperson told CNN on Wednesday.
Protect Children Before Immunizations
While younger children are not yet protected by the vaccine, others can help protect them.
"If we are going to give our chance to fight to have a successful school year, we will need everyone who is eligible for the vaccine to get vaccinated and everyone to wear a mask," Dr. Peter Hotez, dean of the National School, told CNN on Monday. of Tropical Medicine, at Baylor College of Medicine.
Physical distance, good ventilation, good hand hygiene, and masks are essential, especially when children return to school.
"We would love to get to the point where we can vaccinate children and hopefully withdraw some of these measures," Luzuriaga said.
"But we are not at that level yet."
CNN's Lauren Mascarenhas, John Bonifield, Jacqueline Howard and Jamie Gumbrecht contributed to this report.
Covid-19 vaccines