The U.S. Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year.
The announcement is set to come a month after the company found that its shot, which is already authorized for those age 16 and older, also provided protection for the younger group.
The federal official, speaking on the condition of anonymity to preview the FDA’s action, said the agency was expected to expand its emergency use authorization for Pfizer’s two-dose vaccine by early next week, and perhaps even sooner. The person familiar with the process, who spoke on condition of anonymity to discuss internal matters, confirmed the timeline and added that it is expected that the FDA will approve Pfizer’s use by even younger children sometime this fall.
The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.
The New York Times first reported on the expected timing for the authorization.
Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers ages 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.
Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
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Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.
But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6 months old.
Pfizer and its partner in the development of the COVID-19 vaccine, BioNTech, announced that clinical trials were continuing and that it was testing preferred dosing levels for three age groups — between 6 months and 2 years old, 2 to 5 years old, and 5 to 11. The companies will evaluate test results on children ages 5 to 11 first, before moving to the younger age groups.
BioNTech co-founder and chief medical officer Dr. Ozlem Tureci said last week that because results from trials on children from 5 to 11 would be done first, it’s likely that younger children would not get the vaccine until the end of the year.
“We expect the data at the end of the summer or autumn of this year. We will then file it with the regulators and, depending on how fast they react, by the end of the year we might get approval to also immunize younger children,” Tureci said.
More than 131 million doses of Pfizer’s vaccine have already been administered in the U.S., where demand for vaccines among adults has dramatically slowed in recent weeks.
While younger people are at dramatically lower risk of serious side effects 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.
The U.S. has ordered at least 300 million doses of the Pfizer shot by the end of July, enough to protect 150 million people.
Local doctors encourage parents to trust process as FDA prepares to make decision on Pfizer vaccine use for teens
Children 12 to 15 years old could soon get vaccinated -- the FDA will likely make a decision on using Pfizer’s vaccine for kids by next week.
Currently, it is the only vaccine those 16 and older can get.
Channel 9′s Tina Terry spoke to local health officials at Novant Health about the development and they called it good news for the community. They said if and when the Pfizer vaccine is approved for adolescents, they will be ready to distribute it.
Pfizer has said its vaccine demonstrated 100% efficacy in those who are 12 to 15 years old and it created robust antibody responses, even exceeding those reported in the trial of vaccinated 16- to 25-year-olds.
Dr. David Priest with Novant Health said that is good news and very rare in the scientific community.
Channel 9 asked why that age group may have responded so well to the vaccine.
“Younger people have vigorous immune systems and respond well to vaccination,” Priest said. “Adolescents will respond vigorously, they’ll be protected, quickly and longer than other folks.”
While the FDA still has to approve the product for children, Priest said he is encouraging parents to trust the investigative process.
“No manufacturer of a vaccine wants to put out a bad vaccine for children,” Priest said. “It could bankrupt a company. They care very much about safety. If they prove they have a safe and effective vaccine, that’s good for their business.”
Some parents who were taking their second Pfizer shot at Bank of America Stadium on Tuesday told Channel 9 they were excited about this possibility and what it could mean for their families.
“I’m a parent and I’m a grandparent,” Laurie Platner said. “I would absolutely support getting the vaccine for the 12- to 15-year-olds. They’re out there with all of everybody and then, they come home.
Priest said there are several reasons parents should consider vaccinating their children.
“One, you protect that individual child,” Priest said. “Two, you prevent spread of COVID in the community, which protects all of us.”
He said adolescents could also help bring us closer to herd immunity, a goal several national experts have said would be hard to reach based on current vaccination trends.
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“That’s a whole segment of the population. Those under 16 have not been a candidate for the vaccine so to get to that herd immunity number, there’s a whole group that we can immunize to try and get there,” Priest said. “We’re excited about that.”
New data shows children are accounting for more COVID-19 cases in the country recently.
According to the American Academy of Pediatrics, children 18 and younger accounted for 22% of new infections in the last week of April. The week before, they made up about 21% of new infections.
Since the pandemic began, 13.8% of COVID patients in the country have been children. Six states including South Carolina reported children made up 18% or more of their cases.
But how willing are parents to get their kids protected by getting them vaccinated against COVID-19?
A survey found more than a quarter of U.S. parents don’t intend to. Indiana University Bloomington surveyed nearly 2,000 parents and they found 34% of the mothers said they do not plan to vaccinate their kids while 17% of fathers said they don’t.
The Associated Press and The Cox Media Group National Content Desk contributed to this report.
Cox Media Group