'How much longer will little kids have to wait?' Doctors send letter to FDA demanding COVID vaccines for kids under 5 – USA TODAY

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Dr. Rebekah Diamond’s heart broke as she watched another mom sobbing in the intensive care unit.
Her 7-year-old son became severely ill with COVID-19 during the delta wave in the fall. The vaccine had just been authorized for children 5 to 11 years old, but the boy came in contact with the virus before he could make it to his scheduled appointment.
“I did everything right for so long and then I decided he just has to go back to school this fall and I sent him back,” she told Diamond, an assistant professor of pediatrics at Columbia University and a hospitalist at NewYork-Presbyterian Hospital. “I feel like this is my fault … I did this.”
“It was really agonizing to watch her say that,” Diamond told USA TODAY. While the mother may have blamed herself, Diamond blamed regulators for delaying authorization of a safe and effective vaccine for children.
The 7-year-old recovered but the scene of his crying mother haunted Diamond as the omicron variant ripped through New York City, sending hundreds of children to the hospital each week. As she cared for a new wave of patients, many of them under 5 years old and not eligible to get vaccinated, her frustration with regulators grew.
Diamond, who has a 4-year-old daughter, and about 250 other doctors sent a letter to the Food and Drug Administration Thursday morning demanding children under 5 get “urgent access” to COVID-19 vaccines. The letter argues the science supports immediate vaccine access and “procedural red tape” is preventing that. 
“The reason why we’re not approving is not from a lack of data,” Diamond said. “It’s because bureaucratic regulations, likely designed for safety reasons, is now interfering with what’s scientifically sound.”
Parents of young children were hopeful Pfizer-BioNTech’s COVID-19 vaccine would be available to their little ones by the beginning of 2022.
However, hopes were dashed when Pfizer announced early tests showed the 3-microgram dose given to 2- to 5-year-olds didn’t produce as much immune protection as did shots given to other age groups. The company hopes a third dose of vaccine will provide the desire effectiveness, but that means waiting until late March or early April for results.
“I was so completely gutted when I saw the news that their trials were extended,” said Michelle Tsai, 43, a Brooklyn resident whose 2-year-old daughter, Napali, has been unable to go to physical therapy. “How much longer will little kids have to wait to be protected by a vaccine that everyone else has access to?”
In a statement sent to USA TODAY, Pfizer said it hopes to have results in the first half of 2022 and if successful, be able to submit their data to the FDA “shortly after.” 
“We’re working with regulators and health authorities every step of the way and will share new updates on the program or plans to submit as soon as we have them available,” a company spokesperson said. 
Based on previous actions by the FDA, the COVID vaccine may be available for children 2 to 4 around May, said Dr. Robert Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital. Children 6 to 24 months may have to wait until late summer or fall.  
An FDA spokesperson told USA TODAY children are still growing and developing, and it’s important to conduct thorough and robust clinical trials of adequate size to evaluate safety and effectiveness in this population. 
“FDA has been working closely with the vaccine manufacturers to evaluate ways to further expedite the development of a COVID-19 vaccine for children less than 5 years of age,” the agency said. “Making a vaccine available to this population, without sacrificing safety and effectiveness, is critical to our pandemic response and a high priority for the agency.  To that end, we are committed to leveraging all available data in keeping with our high standards to make this happen as quickly as possible.” 
Thursday’s letter to the FDA was organized by “Protecting Their Future,” a grassroots group advocating for child COVID-19 vaccines that was born out of a Facebook page two weeks ago, according to one of its founders Fatima Khan.
The letter was sent to FDA Acting Commissioner Dr. Janet Woodcock, and offered two solutions to “cut the red tape.” One solution includes making it possible for pediatricians to prescribe the 10-microgram dose vaccine – authorized for children 5 to 11 – “off-label.”
Pediatricians in the letter argue the lower-dose vaccine should be available off-label to discuss with parents in a joint-making decision for their child. 
“Pediatrics, there’s very little data in it … I’ve given much more experimental drugs with much less data,” Diamond said. “I use off-label medications as much as I use on-label medications.”
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She uses her skills to determine the use of off-label medications every day, why can’t she do that with the vaccine? Vaccine experts say it’s risky. 
“If you are given a (higher) dose, you could be introducing tolerance particularly in those young kids. You can antigenically imprint them so that they don’t respond in the future,” said Dr. Greg Poland, professor of medicine and infectious diseases and director of the Mayo Clinic’s Vaccine Research Group. “What if they develop myocarditis at a higher rate? We know nothing about vaccine-induced myocarditis.” 
In 2020, Pfizer-BioNTech ran a 40,000-person trial to prove effectiveness in people 16 and older. But as is standard with vaccines like the flu vaccine, the FDA allowed the companies and other COVID-19 vaccine-makers to run much smaller trials in other age groups.
They just have to show that immune responses are comparable – which has been true for every group except 2- to 5-year-olds.
Younger children were given a 3-microgram dose of the same vaccine given to adults and adolescents at 30 micrograms, and to children ages 5 to 12 at 10 micrograms.
Children ages 6 months to 2 years did mount an adequate immune response at that 3-microgram dose, said Dr. Alejandra Gurtman, vice president of vaccine clinical research and development for Pfizer said at a meeting of the Advisory Committee on Immunization Practices.
But all ages under 5 must show comparable protection before the vaccine can be available to babies and toddlers.
“For a mom of a 2-year-old, it’s so frustrating,” said Khan, who also is one of the letter’s organizers. “I feel like people in leadership aren’t paying attention, and kids under 5 are collateral damage to a bigger system.”
The letter proposes to remove the age de-escalation barriers so that doses already proven to be safe and effective for younger age groups can move forward in the approval process.
However these age groups are the standard for pediatric clinical trials, other experts argue, and changing that in the middle of a pandemic can be dangerous.
“For the past eight decades in the U.S, we have accumulated a large body of experience in how to design vaccine trials to demonstrate optimal safety and effectiveness,” said Dr. Jim Versalovic, pathologist-in-chief and COVID-19 command center co-leader at Texas Children’s Hospital. “Once we start splitting these groups, then we get into some uncharted territory and it’s risky.”
The letter is not meant to permanently remove regulatory barriers that make vaccines and medications safe, Diamond said. Instead, she sees it as a temporary solution to a  longstanding problem.
“The real problem is why we didn’t prioritize pediatric trials,” she said. “This is a Band-Aid solution … the best solution long-term would be preventing even getting to this situation.”
The letter goes beyond other calls for change in that it offers several valid solutions, but Versalovic says there’s too much risk in “changing the rules of the game in the middle of a match.”
“I understand that it is difficult to have to wait for a vaccine for our younger children,” Frenck said. “However, by performing rigorous safety and immune testing, we will have the information to be able to say the vaccine is safe and immunogenic in younger children and thus parents can have confidence in having their children vaccinated.”
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Until a vaccine is available for younger children, experts say the best way to protect them is to ensure everyone eligible for a vaccine is vaccinated.
In the U.S., less than half of children 12 or older are vaccinated against COVID-19, Frenck said. Vaccination rates among children 5 to 11 hover around 17% nationally, with some states having rates under 10%.
“We’re just not quite ready for prime time for the under fives,” Versalovic said. “It’s a tough message to deliver … (but) we all need to keep the faith and make sure that children grow and thrive despite the pandemic.”
Contributing: Karen Weintraub, USA TODAY. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT. 
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.


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