The decision was hailed by President Joe Biden "as one more giant step in our fight against the pandemic," and he called on parents to get their kids inoculated. "The bottom line is this: A vaccine for kids between the ages of 12 and 15 . . . [is] safe, effective, easy, fast and free," he said. "So my hope is that parents will take advantage of the vaccine and get their kids vaccinated."
The vote Wednesday afternoon by the Advisory Committee on Immunization Practices, an independent group of medical and public health experts, was 14 in favor, with one recusal. CDC Director Rochelle Walensky signed off by day's end, giving the green light for the two-dose vaccine to be used in 12- to 15-year-olds.
"Getting adolescents vaccinated means their faster return to social activities and can provide parents and caregivers peace of mind knowing their family is protected," Walensky said.
The Food and Drug Administration cleared the vaccine for emergency use in that age group Monday, saying it was safe and effective at the same dose that is being given to those 16 and older.
Biden said that 15,000 pharmacies are ready to start vaccinating adolescents as soon as Thursday, saying most of those pharmacies are no farther from family's homes than their neighborhood schools. Children will be able to receive their two Pfizer shots in different places if they change locations this summer, he said.
The vaccine's cold-storage requirements and large lot size - 1,170 doses is the minimum order - make it more challenging to be distributed immediately to doctors' offices. But Biden said officials are also mobilizing to find ways to equip doctor's offices, including pediatricians, so they can give the shots to patients coming for check-ups, or other services. He described these efforts as enabling parents and children to consult the doctors they trust.
Vaccinating children is a key to boosting the level of immunity in the population, and reducing hospitalizations and deaths, experts say. As more adults are vaccinated, adolescents 12- to 17-years-old are making up a greater proportion of infections, accounting for 9% of cases reported in April, according to CDC data presented at the meeting. That's even higher than cases among people 65 and older, now that many people in that age group are vaccinated.
"Older children can have severe disease from covid-19 infection," said Kathy Poehling, a pediatrics professor at Wake Forest University and member of the advisory panel, who described a teenager with covid-19 who suffered a heart attack as a result of the disease, and who survived. While deaths are uncommon in children, she and others noted that covid-19 deaths are one of the top 10 causes of death for children.
"Many parents and adolescents want to be protected by being vaccinated. And I'm so glad we have the vote to enable them to do that today," she said.
Jose Romero, the panel chair and Arkansas' health secretary, said the action brings the United States "one more step closer to gaining immunity and bringing the pandemic closer to the end."
Referring to studies of the effectiveness of the Pfizer-BioNTech and Moderna vaccines in children as young as infants, Romero added that "we still have the younger age group to deal with, and we are dealing with that. And we still need to vaccinate the rest of the world. But we've made significant steps."
Some states, including Arkansas, Delaware and Georgia, did not wait for the CDC decision, opening up eligibility on Tuesday, a day after the FDA authorized the vaccine for younger teens. But many other states and providers were waiting for the recommendation; some insurance plans won't reimburse providers for the administration fee without the CDC sign-off.
Vaccination of a significant number of adolescents could also allow U.S. schools and summer camps to relax masking and social-distancing measures recommended by the CDC, and help speed a return to normalcy. There are almost 17 million adolescents in the 12- to 15-year-old age group in the United States, accounting for about 5.3% of the U.S. population and almost 27% of the population younger than 16, according to the Kaiser Family Foundation.
The only debate by the advisory panel occurred when members questioned whether the Pfizer-BioNTech vaccine should be given alongside other childhood or adolescent vaccines in the absence of data on how it might interact with them. That's an issue because routine immunizations have fallen sharply during the pandemic, a decline of nearly 12 million doses as of May 2, compared with 2019, according to a CDC presentation.
The gap is largest in vaccines primarily given to adolescents, including the one targeting the human papillomavirus, known as HPV, and another to prevent tetanus, diphtheria, and pertussis.
A CDC slideset presented at the meeting said that "substantial data" have been collected regarding the safety of coronavirus vaccines and also noted that "extensive experience" with other vaccines demonstrates their side effects and ability to generate an immune response are "generally similar when vaccines are administered simultaneously as when they are administered alone."
For that reason, the presentation said that covid-19 and other vaccines "may now be administered without regard to timing," including giving them on the same day as well as within 14 days.
But several panel members said they wanted more data, asking manufacturers to study how the Pfizer-BioNTech vaccine might interact with other routine vaccines. Sarah Long, a pediatrics professor at Drexel University said she was "not at all comfortable with deciding right now how these vaccines can be used concurrently with anything, without any data."
After the discussion, panel members agreed the vaccine could be given at the same time as other vaccines, but asked that the CDC spell out more detailed instructions for providers that would take into account whether a patient is behind on recommended vaccines, or at risk of becoming so, and whether certain vaccines are more likely to produce side effects.
Yvonne Maldonado, a pediatrics professor at Stanford University and the panel's liaison from the American Academy of Pediatrics, said the pediatrics group would be issuing a statement to support the administration of multiple vaccines at the same time, "given the importance of routine vaccinations and the need for rapid uptake of covid-19 vaccines."
The FDA based its emergency authorization Monday on a trial of nearly 2,300 adolescents between 12 and 15 years old, half of whom received the same two-shot regimen shown effective and safe in adults. There were no cases of covid-19 among fully vaccinated adolescents, compared with 16 among children given a placebo, suggesting the regimen offered similar protection to younger recipients as it does to adults.
The younger teens had the same side effects as adults, mostly soreness at the injection site and flu-like fever, chills or aches, especially after the second dose.
In testimony before a Senate committee Tuesday, Walensky encouraged parents to get their children vaccinated, saying she knew some wanted to wait to see how the administration of shots goes.
"Some parents want to be first, but I'm also encouraging children to ask for the vaccine," she said. "I have a 16-year-old myself, and I can tell you he wanted to get the vaccine. He wants his life back. These kids want to go back to school."
Biden said his administration would launch a public education campaign about the vaccine and partner with a variety of organizations to encourage children to get vaccinated.
In Alaska, some school districts already have scheduled vaccination clinics for Thursday and Friday because parents are eager for their children to get the shots before the school year ends, Anne Zink, Alaska's chief medical officer, told reporters Tuesday.
"States have been planning and preparing for, and are now rolling out their plans for vaccinating this group of adolescents," said Nirav Shah, director of Maine's Center for Disease Control and Prevention and president of the Association of State and Territorial Health Officials.
There is no federal legal requirement for parents or guardians to give consent for coronavirus vaccinations or any other vaccination. But the vaccines must be given according to state vaccination laws, including those related to consent.
Most coronavirus vaccines worldwide have been authorized for adults. Pfizer's vaccine is being used in multiple countries, including the United States, for teens as young as 16. Canada recently became the first to expand use to those 12 and older. Parents, school administrators and public health officials have eagerly awaited approval for the shot to be made available to more children in the United States, particularly with the growing gap between what vaccinated and unvaccinated people may do safely.
Although adolescents are less likely than adults to be hospitalized or have severe illness because of coronavirus infection, there is no way to predict the few who will become critically ill or develop a rare, dangerous inflammatory syndrome. Out of more than 581,000 covid-19 deaths in the United States, only about 300 have been among those younger than 18. But that exceeds the number of children who die in a bad flu season.
Parents' eagerness to get their children vaccinated varies. A CDC presentation, citing four surveys, said about half of parents plan to get their children vaccinated.
A Kaiser Family Foundation survey found three in 10 parents of children ages 12 to 15 say they will get their children inoculated as soon as a vaccine is available; one-quarter say they will wait a while to see how the vaccine is working; 18% plan to get their children vaccinated if their schools require it; and nearly a quarter say they will definitely not have their children vaccinated.
The Kaiser poll found that parents' intentions about having their children vaccinated against the coronavirus largely align with their attitudes toward being vaccinated themselves.
Sara Oliver, a CDC medical officer and the lead of the panel's covid-19 working group, said officials plan to promote adolescent vaccination as quickly and equitably as possible.
The plan is to expand vaccinations down to 12-year-olds at existing sites as part of an "early summer sprint" in May and June, followed by increased access in June and July that will include children's hospitals and large health-care providers serving adolescents. A back-to-school campaign will kick off later in the summer and include school-based vaccination programs and pharmacies after the start of the school year.
Published : May 13, 2021
By : The Washington Post · Lena H. Sun, Fenit Nirappil