WASHINGTON - An advisory panel for the U.S. Centers for Disease Control and Prevention voted Wednesday to endorse the Pfizer-BioNTech COVID-19 vaccine for older children ages 12 to 15, one of the final steps toward making the shots widely available for the age group in an effort to speed up the return to schools.
The approval from the CDC’s Advisory Committee on Immunization Practices follows the Food and Drug Administration on Monday expanding its emergency use authorization of the Pfizer vaccine for ages 12 to 15. The FDA cited evidence that the shots worked as well for the younger age group as for those 16 and older.
The CDC committee’s endorsement now awaits final approval by CDC Director Dr. Rochelle Walensky.
States have already begun to roll out Pfizer’s two-dose vaccine to pediatricians and even some school vaccine clinics as the nation prepares to vaccinate millions of kids within the age group. Children in some places already have rolled up their sleeves, though much of the nation has been awaiting the recommendations from the CDC.
President Joe Biden said the approval of the shot for adolescents is "one more giant step in our fight against the pandemic."
"I sincerely thank the scientists, researchers and clinical trial participants. They’ve all made this possible. Because of them, nearly 17 million more Americans are eligible to get vaccinated - and now," Biden said.
"As I promised last week, we’re ready. This new population is going to find this vaccination rollout fast and efficient. As of tomorrow, more than 15,000 pharmacies across the country are going to be ready to vaccinate this age group," he continued.
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Among the outstanding questions: Is it OK to get vaccinated against COVID-19 at the same doctor’s visit as people receive some routine vaccinations? The question has been an urgent back-to-school concern, especially for the 12- to 15-year-olds, who have missed out on regularly scheduled vaccines during the pandemic.
Until now, the CDC has recommended not getting other vaccinations within two weeks of a COVID-19 shot, mostly as a precaution so that safety monitors could spot if any unexpected side effects crop up. But the CDC said Wednesday it is changing that advice because the COVID-19 vaccines have proved so safe — and that health workers can decide to give another needed vaccine at the same time.
The American Academy of Pediatrics on Wednesday also endorsed the Pfizer vaccine for the 12-and-up crowd — and agreed that it's fine to give more than one vaccine at the same time, especially for kids who are behind on their regular vaccinations.
Pfizer said in April a study of more than 2,000 12- to 15-year-olds found it offers strong protection. There were no cases of COVID-19 among volunteers given the two-shot vaccination compared with 16 in the group given dummy shots. Kids got the same dose as adults but developed even higher levels of virus-fighting antibodies.
Side effects were found to be the same as adults have experienced, mostly sore arms and flu-like fever, chills or aches that signal the immune system is revving up. But not surprisingly they were a little more common in the kids. Headache, for example, occurred in half of people 16 and older but in three-quarters of the younger teens in Pfizer’s studies.
Experts say vaccinating Americans of all ages is critical to getting back to normal. Children make up about a quarter of the country’s population, and there’s plenty of supply for the nation’s nearly 17 million 12- to 15-year-olds.
Pfizer is not the only company seeking to lower the age limit for its vaccine. Moderna recently said preliminary results from its study in 12- to 17-year-olds show strong protection and no serious side effects, data the FDA will need to scrutinize.
Earlier this month, Biden said the administration was "ready to move immediately," pending approval. He added that vaccines will also be shipped directly to pediatricians, "so parents and their children can talk to their family doctor about it and get the shot from a provider they trust the most."
While younger people are at a dramatically lower risk of serious complications from COVID-19, they have made up a larger share of new virus cases as a majority of U.S. adults have been at least partially vaccinated and as higher-risk activities like indoor dining and contact sports have resumed in most of the country. Officials hope that extending vaccinations to teens will further accelerate the nation’s reduced virus caseload and allow schools to reopen with minimal disruptions this fall.
As for even younger children, both companies have begun tests in youngsters ages 6 months to 11 years. Those studies explore if different doses are needed at the youngest ages, and FDA plans to hold a public meeting next month to debate exactly what evidence is needed.
This story was reported from Cincinnati. The Associated Press contributed.