Enthusiastic parents want to vaccinate young children, and they want to do it now — but no vaccine is allowed for people under the age of 12.
There is a waiting list of 2,000 people to participate in Wiedermann’s Covid-19 vaccine trial at Chlldren’s National Hospital, where he is an infectious disease specialist.
“I definitely understand where people are 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 the school is just around the corner,” Wiedermann said. “So things are starting to pile up and parents and kids are getting worried about that.”
Pediatricians say FDA needs to act faster
The American Academy of Pediatrics understands the fear and impatience of parents. AAP chairman Dr. Lee Savio Beers said there needs to be more urgency around the approval of the Covid-19 vaccine for young children in the United States.
“It’s very important to ensure that we approach the approval of the Covid vaccine for our youngest children with the same urgency as we do with adults,” Beers told CNN’s Wolf Blitzer on Tuesday. “It is really a very urgent situation.”
Beers’ organization wrote a letter last week to acting commissioner of the U.S. Food and Drug Administration, Dr. Janet Woodcock, in which he called on the FDA not to delay licensing.
Last month, the FDA asked Pfizer and Moderna to double the number of children ages 5 to 11 in clinical trials. The FDA also asked for six months of follow-up safety data, rather than the two months it asked for in adults.
“While we appreciate this cautious step to gather more safety data, we urge the FDA to carefully consider the impact of this decision on the timeline for authorizing a vaccine for this age group,” the letter reads.
The AAP argued that the FDA should approve the vaccines for children ages 5 to 11 based on the initial research data already available. Two months of safety data should also suffice, it said.
“Waiting for a 6-month follow-up will significantly hamper the ability to reduce the spread of the hyperinfectious Covid-19 delta variant,” the letter said.
Vaccine advisers from the US Centers for Disease Control and Prevention said in June there is a likely link between the mRNA Covid-19 vaccines and extremely rare cases of heart inflammation in adolescents and young adults, but 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 immunologic or inflammatory events occur more than two months after Covid-19 vaccine administration,” the letter said.
U.S. Surgeon General Dr. Vivek Murthy said on Wednesday the FDA will “act quickly” to evaluate data from vaccine companies once it’s ready, and it’s possible that a Covid-19 vaccine will be available for children under 12 before the end of 2021.
“If all went well and everything fell into place, I think it’s possible we could see a vaccine for children under 12 before the end of the calendar year,” Murthy told CNN’s Wolf Blitzer.
“Make no mistake, the FDA will be quick to respond to this because they recognize what’s at stake. It’s our children’s health, and there really is nothing more important than that.”
No ‘luxury’ time for extra data
Still, Dr. Yvonne Maldonado, a 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 approval.
“We don’t have the luxury of sitting back and waiting for additional data like this to come in,” said Maldonado, who is also a principal investigator on the Stanford site of Pfizer-BioNTech’s pediatric vaccine trial. “We need to make some decisions based on best practices.”
Maldonado is concerned that the FDA is listening too closely to its critics.
“We can’t stop now because people are questioning what the FDA is doing,” Maldonado said.
dr. Paul Offit, a member of the FDA’s vaccine advisory committee, said he can’t understand why the FDA asked for more data?. “The longer follow-up for safety makes no sense. You really only need two months,” Offit said.
He hopes his committee will soon have data from the trials to review.
“You know I’m frustrated,” Offit said. “As we get further into the fall, this is at greater risk for children.”
dr. Bill Mueller, who has worked on Moderna’s pediatric studies, thinks some parts of the process have been slow, but he favors additional data.
“We have to be very careful about expanding the authorization to a really large population of patients,” said Mueller, scientific director at community and clinical trials, Stanley Manne Children’s Research Institute.
“That doesn’t mean we should be overly cautious,” says Mueller, an attending physician for pediatric infectious diseases at Ann & Robert H. Lurie Children’s Hospital in Chicago. “The question will really be one of balance.”
With the more 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 rose in the past week, the American Academy of Pediatrics said in what the group described as a “sustained substantial increase.” The vast majority of children do not end up in hospital, but as of Saturday, the number of children newly admitted to hospital rose 21% week over week, the CDC said.
Why children’s experiments are necessary?
Before a vaccine can be tested on children, scientists test it on adults.
“It’s to protect children and to protect their safety and well-being,” said Dr. Daniel B. Blatt of the Norton Children’s and University of Louisville School of Medicine, who has worked on the Covid-19 pediatric trials for the Pfizer vaccine.
Most often, researchers use a so-called age de-escalation model, he said. Scientists start with adults, and once they see it’s safe to do so, they move the research to older children and then to younger children. It is a time consuming but necessary process.
While the Covid-19 vaccines have been proven to be safe and protective in millions of people, scientists cannot simply extrapolate that to younger children.
“Children are not just miniature adults, their immune systems are different,” says Dr. Katherine Luzuriaga, professor of molecular medicine, pediatrics and medicine at UMass Medical School, who is working on the pediatric trial of Pfizer. “The way they react can sometimes be different.”
In a trial, scientists begin the study by essentially making their best educated guess as to what dose would be safe and generate an immune response to protect the child from getting Covid-19.
“It’s that kind of Goldilocks approach that’s not too big, not too small,” Luzuriaga said.
There is a review of the data throughout the process to ensure there are no concerns about product safety.
Vaccine Timeline for Younger Children
“I think by the end of the fall, if all goes well, we will hopefully have enough information and data to support us for that age group,” Luzuriaga said.
Data for children ages 5 to 11 could come sometime in September, depending on the findings, Pfizer told CNN it could ask the FDA to approve the vaccine that same month.
Data for 2- to 5-year-olds could arrive soon after. For the youngest children, Pfizer said it could potentially get data in October or November and ask the FDA shortly after to allow emergency use.
Emergency considerations by the FDA could take several weeks, meaning a vaccine for younger children probably won’t be available until late fall or even next year.
Pediatricians never feel like things are moving fast enough, especially when they have a patient in front of them who needs something, Luzuriaga said — but research takes time.
“I think we’re getting close,” said Luzuriaga.
Moderna told CNN it expects data later this year or early 2022. There may also be intermediate data at different stages of the process, but that timeline is difficult to predict.
Johnson & Johnson told CNN it used its small 16- and 17-year-old trial from earlier this year to design four late-stage studies for younger children, and the company is in “active discussions with regulatory authorities about our development plans.” and trial designs.” The company expects those trials to begin in the fall.
“To keep children safe, and ultimately to achieve herd immunity, it is imperative that clinical trials of COVID-19 vaccines continue to progress in this population, and we remain deeply committed to the critical work needed to make our COVID-19 vaccine accessible in a fair way. for all age groups,” a J&J spokesperson told CNN on Wednesday.
Protecting children before vaccines
While younger children don’t yet have the protection of the vaccine, others can help protect them.
“If we’re going to give our struggles a chance to have a successful school year, we need everyone who is eligible for a vaccine to get vaccinated and everyone who is masked,” Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told CNN Monday.
Physical distancing, good ventilation, good hand hygiene and masks are all essential, especially now that children are back in school.
“These things, while not ideal, we would like to get to the point where we can vaccinate children and hopefully pull some of these measures back,” Luzuriaga said. “But we’re not at that level yet.”
CNN’s Lauren Mascarenhas, John Bonifield, Jacqueline Howard and Jamie Gumbrecht contributed to this report