NEW YORK (AP) — Children ages 12 and older can now roll up their sleeves for COVID-19 vaccines in the U.S., offering parents and schools a chance to relax their pandemic precautions and bringing the country a step closer to controlling the virus.
A government advisory committee recommended Pfizer’s vaccine for children 12 and older on Wednesday, after the Food and Drug Administration expanded authorization of the shots to the age group earlier in the week.
Here’s what you need to know:
ARE THE SHOTS THE SAME AS THOSE FOR ADULTS?
Yes. The dose and the schedule are the same; the two shots are given three weeks apart.
WHERE CAN KIDS GET THE SHOTS?
Pharmacies, state sites and other places that are already vaccinating people 16 and older with the Pfizer vaccine should be able to give the shots to all authorized ages in most cases.
“All those sites can simply extend down to the younger age group,” Dr. Janet Woodcock, the FDA’s acting commissioner, said in a call with reporters after the agency expanded authorization.
School districts are also preparing to host vaccination clinics to speed up the campaign. And since parents might feel more comfortable with their pediatricians and primary care doctors, health officials are working to make the shots more widely available at private practices.
WILL KIDS NEED A GUARDIAN?
Parental consent will be needed, but exactly how it’s obtained could vary.
For vaccinations at school-based clinics, for example, parents might be able to give consent by signing a form, said Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention and president of Association of State and Territorial Health Officials.
Walgreens said a parent or guardian will need to be present and sign a consent form, but noted guidelines on parental consent vary by jurisdiction.
In Pennsylvania’s Montgomery County, anyone under 18 needs to be accompanied by a parent or guardian. Proof of guardianship and the child’s age aren’t being checked, said Kelly Cofrancisco, a spokeswoman for the county, which began vaccinating younger teens Tuesday.
HOW WAS THE VACCINE VETTED FOR KIDS?
Pfizer’s late-stage vaccine study tested the safety and efficacy of the shots in about 44,000 people 16 and older. The study then enlisted about 2,200 children ages 12 to 15 to check for any differences in how the shots performed in that age group.
“This is just extending it down from 16 and 17 year olds, and getting further information,” Woodcock said.
None of the children who got the real shots in the study developed COVID-19, compared with 16 who got the dummy shots. That confirmed previous finding among adults that the shots are highly effective.
Children were also followed for two months after the second shot as part of the study.
Dr. Sharon Nachman, chief of pediatric infectious diseases at Stony Brook Children’s Hospital, said there’s no reason the shots would be less effective or have any unique safety issues in children compared with adults.
WHY ONLY THE PFIZER VACCINE?
Because only Pfizer, which developed the vaccine with its German partner BioNTech, has completed studies in younger teens. Moderna recently said preliminary results from its study in 12- to 17-year-olds show strong protection and no serious side effects, but regulators still need to review the results before it can be offered to younger people.
WHAT SIDE EFFECTS ARE EXPECTED?
Common side effects were similar to those experienced by adults, and included fatigue, headache, muscle pain and fever. Except for pain in the arm where the needle is injected, the effects were likelier after the second shot.
Dr. Michael Smith, medical director of the Duke Children’s Health Center Infectious Diseases Clinic, noted that younger people tend to have more robust immune systems that respond better to vaccines. That explains why side effects were more common in the 12 to 15 age group than among adults, he said.
It’s also why trials for children younger than 12 are testing different doses.
“You need to find that dose that is enough to give a good immune response, without giving too many side effects,” Smith said.
Dosages for children and adults are the same for many other vaccines, he noted.
CAN KIDS GET OTHER ROUTINE VACCINATIONS AT THE SAME TIME?
The Centers for Disease Control and Prevention said it’s updating its guidance to say other routine vaccinations can be given at the same time as the COVID-19 shots. It previously advised against other vaccinations within a two-week window so it could monitor people for potential side effects.
The American Academy of Pediatrics said it agrees with the position.
WHEN WILL YOUNGER KIDS BE ELIGIBLE?
It’s unclear how long the ongoing trials or regulatory reviews will take. But Dr. Anthony Fauci, the top U.S. infectious disease expert, recently suggested it could happen this year.
“We think by the time we get to the end of this year we will have enough information to vaccinate children of any age,” he said.
WHY SHOULD KIDS GET VACCINATED?
Even though children are far less likely to get severely ill if infected, health officials note the risk isn’t zero.
Vaccinating children is also key to ending the pandemic, since children can get infected and spread the virus to others, even if they don’t get sick themselves.
About 20% of the U.S. population is younger than 16, according to Census data. That included about 16.7 million children ages 12 to 15 in 2019.
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The Associated Press Health and Science Department receives supportfrom the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
US advisers endorse Pfizer COVID shot for kids 12 and up
U.S. health advisers endorsed use of Pfizer’s COVID-19 vaccine in kids as young as 12 on Wednesday — just as planned new guidelines say it’s OK for people of any age to get a coronavirus shot at the same time as other needed vaccinations.
The shots will let kids safely attend camps this summer and help assure a more normal return to classrooms next school year, concluded advisers to the Centers for Disease Control and Prevention.
“And this is another way to get closer to ending this horrible pandemic,” said adviser Dr. Camille Kotton of Harvard Medical School.
The sprint to vaccinate millions of middle and high school students has already started in parts of the country, as a long line of kids rolled up their sleeves in suburban Atlanta for a first dose Wednesday.
“It just felt like a flu shot, honestly,” said Meredith Rogers, 14, from Decatur, Georgia, after getting her vaccination.
Michelle Rogers, Meredith’s mother, said she hoped the youth vaccinations would help bring some normalcy back.
“A little apprehensive, but you know what? This is a step towards getting life back to normal so, we’re all in,” Michelle Rogers said with a slight fist pump.
Pfizer’s vaccine has been used for months in people 16 and older, and earlier this week the Food and Drug Administration cleared its use for those as young as age 12. But before rolling it out to the younger kids, much of the nation was awaiting recommendations from CDC’s advisers — and the panel concluded the same dose adults use is safe and strongly protective in those 12 to 15 years old, too.
The CDC rapidly accepted its advisers’ recommendation.
A key question: Is it OK to get vaccinated against COVID-19 at the same doctor’s visit as people receive some routine vaccinations? That’s 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 — but it’s an issue for adults, too.
The CDC until now 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 cropped up.
But the CDC said Wednesday it is changing that advice because the COVID-19 vaccines have proved very safe — and that health workers can decide to give another needed vaccine at the same time for people of any age.
“The need for catch-up vaccination in coordination with COVID-19 vaccination is urgent as we plan for safe return to school,” CDC’s Dr. Kate Woodworth told the panel, citing millions of missed doses of vaccines against tetanus, whooping cough and other health threats.
The American Academy of Pediatrics on Wednesday also urged that kids 12 and older get the Pfizer vaccine — 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.
Children are far less likely than adults to get seriously ill from COVID-19 — but they do sometimes die, and thousands have been hospitalized. By last month, those ages 12 to 17 were making up slightly more of the nation’s new coronavirus infections than adults over 65, a group that’s now largely vaccinated.
The two-dose vaccine made by Pfizer and its German partner BioNTech was studied in more than 2,000 kids ages 12 to 15. There were no cases of COVID-19 among vaccinated kids compared with 16 in the group given dummy shots. Kids also developed higher levels of virus-fighting antibodies than vaccinated adults.
Side effects are the same as adults experience, mostly sore arms and flu-like fever, chills or aches that signal the immune system is revving up.
CDC’s advisers did caution that those temporary shot reactions may be even more common if people get a COVID-19 shot at the same time as another vaccination.
President Joe Biden hailed Wednesday’s vote, noting that means 17 million more people in the U.S. now qualify to get vaccinated.
“I encourage their parents to make sure they get the shot,” he said. “As I promised last week, we’re ready. This new population is going to find the vaccine rollout fast and efficient.”
In addition to the mass vaccination sites and health department rollouts that were key for adults, many states will be offering kids more familiar options — shipping doses to pediatricians and even to schools.
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.
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.
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AP reporters Ron Harris in Decatur, Georgia, and Zeke Miller in Washington contributed to this report.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.