U.S. health officials Tuesday gave the final sign-off to Pfizer's kid-size covid-19 shot, a major expansion of the nation's vaccination campaign.
The Food and Drug Administration had already authorized the shots for all children 5-11 -- doses just a third of the amount given to teens and adults -- but it is the Centers for Disease Control and Prevention that recommends who should receive FDA-cleared vaccines.
Tuesday's announcement by CDC director Dr. Rochelle Walensky came only hours after an advisory panel unanimously decided Pfizer's shots should be given to the 28 million youngsters in that age group.
Millions of shots made by Pfizer and its partner BioNTech have already been shipped to states, doctors' offices and pharmacies, awaiting the CDC's decision. They have orange caps, to avoid mix-ups with purple-capped vials of adult vaccine.
"Today is a monumental day in the course of this pandemic and one that many of us have been very eager to see," Walensky said.
She acknowledged that the chances of a child getting severe covid-19 or developing long-term complications remains low. "But still," she said, "the risk is too high and too devastating to our children -- and far higher than for many other diseases for which we vaccinate children."
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Pediatric vaccinations may also cut down on time out of the classroom for children exposed to the virus at school, as 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 said. "Pediatric vaccination has the power to help us change all of that."
The American Academy of Pediatrics welcomed the vote as its members get ready to start the first injections into children's arms. The 5- to 11-year-olds will receive two shots, three weeks apart, the same schedule as everyone else -- but using a smaller needle.
"Sharing this life-saving vaccine with our children is a huge step forward and provides us all with more confidence and optimism about the future," said Dr. Lee Savio Beers, academy president.
"Vaccination of children ages 5 to 11 years will not only help prevent covid-19 infection and serious consequences of infection in this age group, but will also help children emotionally and socially," said Dr. Pamela Rockwell, who represents the American Academy of Family Physicians on the CDC panel.
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."
There was enough information to conclude that the benefits of the vaccine outweighed the risks, even without more long-term safety data, said Dr. Matthew Daley, a senior investigator at Kaiser Permanente Colorado.
"If we wait, we miss the chance to prevent many cases of covid-19 in this age group, and that includes some very severe cases," he said.
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, chairwoman of the pediatrics department at the Robert Wood Johnson Medical School and a member of the National Medical Association, which represents Black 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."
HOLIDAY CONCERNS
Many parents have clamored for vaccine protection for youngsters so they can resume normal childhood activities without risking their health or the possibility of taking the virus home to a more vulnerable family member. But the CDC's advisers said they recognize many parents also have questions and may be fearful of the vaccine because of rampant misinformation.
The panelists said they want parents to ask their pediatrician about the shots -- and to understand that they're far better than gambling that their child will escape a serious coronavirus infection. As for safety, more than 106 million Americans have safely gotten two doses of Pfizer's full-strength shots -- including more than 7 million 12- to 15-year-olds.
"I have vaccinated my kids," said CDC adviser Dr. Helen Keipp Talbot of Vanderbilt University, saying she wouldn't recommend something for other families unless she was comfortable with it for her own. "We have seen the devastation of this disease."
In the U.S., there have been more than 8,300 hospitalizations of kids 5-11, about a third requiring intensive care, according to government data. The CDC has recorded at least 94 deaths in that age group, with additional reports under investigation.
And while the U.S. has recently seen a downturn in covid-19 cases, experts are worried about another uptick with holiday travel and as winter sends more activity indoors where it's easier for the coronavirus to spread.
Pfizer's study of 2,268 youngsters found the kid-size vaccine is nearly 91% effective at preventing symptomatic covid-19 -- based on 16 diagnoses among kids given dummy shots compared with just three who got the real vaccination.
The FDA examined more children, a total of 3,100 who were vaccinated, in concluding the shots are safe. The younger children experienced similar or fewer reactions -- such as sore arms, fever or achiness -- than teens or young adults get after larger doses.
That study wasn't large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. Regulators ultimately decided the benefits from vaccination outweigh the potential that younger kids getting a smaller dose also might experience that risk.
Some of the CDC's advisers said that for some parents, deciding to get their children vaccinated may hinge on that small but scary risk.
"The risk of some sort of bad heart involvement is much higher if you get covid than if you get this vaccine," Dr. Matthew Oster, a pediatric cardiologist at Emory University, told the panel.
"Getting covid, I think, is much riskier to the heart than this vaccine, no matter what age or sex," Oster said.
Last week, the FDA's advisers struggled with whether every young child needed a vaccine. Youngsters hospitalized with covid-19 are more likely to have high-risk conditions such as obesity or diabetes. But otherwise healthy children can get seriously ill too, and the CDC's advisers ultimately recommended the shots for all of them -- even children who've already recovered from a bout of covid-19.
CDC officials calculated that for every 500,000 youngsters vaccinated, between 18,000 and 58,000 covid-19 cases -- and between 80 and 226 hospitalizations -- would be prevented, depending on the pandemic's trajectory. And CDC officials noted that covid-19 has caused more deaths in this age group than did some other diseases, such as chickenpox, before children were routinely vaccinated against them.
Pfizer is also testing shots for babies and preschoolers and expects data around the end of the year. The similarly made Moderna vaccine also is being studied with young children. But the FDA still hasn't cleared its use in teens, and the company is delaying its application for younger children pending that review.
A few countries have begun using other covid-19 vaccines in children younger than 12, including China, which just began vaccinations for 3-year-olds. But many that use the Pfizer-BioNTech vaccine are watching the U.S., and European regulators just began considering the companies' kid-size doses.
PARENTS URGED
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 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 multisystem inflammatory syndrome, or MIS-C, which can affect multiple organ systems in children 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 the 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 CDC 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 the CDC presentation.
By today, more than 3 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.
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 past two weeks. In Texas, for example, only 137 of the state's 254 counties are slated to have shots available in the next 10 days, said Texas Department of State Health Services spokeswoman Lara Anton.
Information for this article was contributed by Lauran Neergaard and Mike Stobbe of The Associated Press; by Lena H. Sun, Katie Shepherd and Laurie McGinley of The Washington Post; and by Apoorva Mandavilli of The New York Times.