CDC advisers back nations first vaccine for 5-to-11-year-olds

CDC Director Rochelle Walensky is expected to endorse the recommendation later Tuesday, allowing some clinicians, pharmacies and other providers to begin giving the two-shot regimen as early as Wednesday.

The sign-off is a watershed moment in the fight against the pandemic, which has killed 745,000 people in the United States. Millions of families have waited for a children's vaccine since the first adult shot was authorized last December, hoping their kids could finally resume in-person schooling and extracurricular activities without interruption - and that their own work schedules could return to normal.

"Today is a monumental day in the course of this pandemic and one that many of us have been very eager to see," Walensky told advisers at the meeting's start.

White House officials say the administration of pediatric vaccinations will be in full gear by next week - welcome news for families who live in multigenerational households and those eager to gather in large groups for the coming holidays. For the substantial number who remain distrustful of the vaccine, public health officials face a gargantuan task of convincing them to allow their kids to get the shots. That task is made more urgent by concerns about another coronavirus wave during the cold-weather months when people spend more time indoors and respiratory illnesses spread more easily.

Several panel members said they have vaccinated older children and grandchildren and plan to get the shots for younger children who are now eligible.

"We have one more vaccine that saves lives of children and we should be very confident to employ it," said Sarah Long, a professor of pediatrics at Drexel University and a panel member. She said eight of her nine grandchildren would be vaccinated as of next week.

Beth Bell, a global health professor at the University of Washington, said many parents are clamoring for the vaccine and she felt a responsibility to make it available. "Will we gain additional knowledge as time goes on?" she asked. "Yes, of course we will. But we do have a pretty robust view of the situation at the moment. This is a huge step forward for children and parents."

Parents have legitimate questions, Bell said, but the panel's 14-0 vote is a way of telling them "that based on our expertise and the information that we have, we're all very enthusiastic."

Patricia Whitley-Williams, chair of the pediatrics department at the Robert Wood Johnson Medical School and a member of the National Medical Association, which represents African American physicians and their patients, said the vaccine is especially important for children at highest risk, many of whom depend on schools "as a safe haven, as well as the source of two meals a day, five days a week."

Recent data show that children are getting infected and transmitting the virus as readily as adults, even though half of them show no symptoms. Vaccinating children is expected to reduce transmission by an estimated 8% among all age groups, or about 600,000 infections through next March, according to a CDC presentation.

Since the start of the pandemic, nearly 2 million children 5-to-11 have been infected by the virus, resulting in 8,300 hospitalizations, including more than 2,300 cases of a complication known as multisystem inflammatory syndrome, or MIS-C, and 94 deaths, according to data presented Tuesday. Among all children, there have been 745 deaths.

Walensky acknowledged the chance of a child getting severe covid-19, or developing long-term complications remains low. "But still," she added, "the risk is too high and too devastating to our children - and far higher than for many other diseases for which we vaccinate children."

Pediatric vaccinations may also cut down on time out of the classroom for children exposed to the virus at school since fully vaccinated individuals do not need to quarantine if they don't show symptoms.

"There are children in the second grade who have never experienced a 'normal' school year," Walensky told the panel. "There are students in middle school who missed out on school sports and extracurricular activities. There are missed proms and homecoming dances. . . . Pediatric vaccination has the power to help us change all of that."

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Side effects

Panel members had a robust debate about a rare heart-related complication called myocarditis that has been linked to both the Pfizer and Moderna vaccines, with males under 30 at highest risk. Follow-up study of the heart problems suggests the vaccine-related cases are generally mild and symptoms resolve promptly, officials have said.

"The risk of having some sort of bad heart involvement is much higher if you get covid than if you get this vaccine," especially for children who develop the complication of MIS-C, said Matthew Oster, a pediatric cardiologist and medical officer at the CDC.

Myocarditis, which can have many causes, is generally not as common among 5-to-11-year-olds as it is among adolescents and young men. And while Pfizer's clinical trial among that age group - which recorded no cases of myocarditis - was too small to forecast the risk for younger children, Oster said he expects to see fewer cases among younger kids.

Scientists say that while it is important to continue monitoring vaccine reactions, most complications would show up within several weeks of when the shots are administered. That's why the FDA required two months of safety data for both kids' and adults' vaccines. CDC and FDA officials say the vaccines are being given under one of the most intensive safety monitoring efforts ever.

Immunization advocates say parents with questions should seek information from pediatricians and other knowledgeable people they trust. The CDC also plans to update its webpages about the vaccine, including one for providers on how to have conversations with parents, and another on myths and facts about coronavirus vaccines.

Amanda Dropic, a pediatrician and mother of four, is among those urging parents to get their kids vaccinated. All her children have been immunized to her great relief, she said, as part of clinical trials.

"I am so glad not to be worrying about long-haul covid, hospitalizations, kids' dying,"' said Dropic, who lives in northern Kentucky. "It feels good. The kids want to go back to normal lives and having birthday parties and doing what kids like to do."

Rosa Vasquez wants the same for her daughter, Xitlali Ramirez, 10, who was hospitalized at Children's Hospital in Los Angeles last year for MIS-C, which can affect multiple organ systems and cause long-lasting effects. Why it sometimes develops after a coronavirus infection is not fully understood. The girl was in a coma for seven days.

"She was very, very sick," Vasquez said. "Thank God she woke up." Everyone else in the family - Vasquez, her husband and her two older children - has been vaccinated. The fifth-grader has eagerly awaited her turn. "She knows about the vaccine and she's waiting for it," Vasquez said. "She told me, 'I don't want to get sick again mom.'"

CDC officials say they plan to provide additional guidance to clinicians on a range of practical questions in coming days. An 11-year-old about to turn 12, for instance, should receive the dosage targeted to his or her age on that day. Vaccine dosages are based on age, not size or weight, unlike many other medications, according to a presentation. The children's dosage is one third the size of that for adolescents and adults.

The vaccine is recommended for all 5-to-11-year-olds regardless of health issues or previous infections, officials said.

Based on clinical trial data, children may also experience fewer side effects than teens or young adults, with the most common being pain, swelling and redness at the injection site, according to a CDC presentation Tuesday.

By Wednesday, more than three million doses of the Pfizer-BioNTech pediatric vaccine are scheduled to arrive at state health departments, with several million more arriving Friday at designated spots, including pharmacies and federal entities, such as the Indian Health service, according to a federal health official who spoke on the condition of anonymity because they were not authorized to speak publicly.

White House coronavirus coordinator Jeff Zients has said a total of 15 million doses will be distributed to children's hospitals, community health centers and rural health clinics "across the next week or so."

But even with such efforts, some parents may initially struggle to sign up their kids.

The vaccine may not be widely available in counties that did not preorder it in the last two weeks. In Texas, for example, only 137 of the state's 254 counties are slated to have vaccines available in the next 10 days, Texas Department of State Health Services spokeswoman Lara Anton said in an email. Providers in many rural counties have not yet placed orders, but the state is working to make shots available through health department-run clinics. In addition, some pharmacies in rural areas may receive vaccine directly from the federal government, Anton added.