“The way we’re really going to control this pandemic is to vaccinate a higher number of individuals, including children,” Dr. Sherman Alter of Dayton Children’s said Tuesday. “While it generally is a milder illness, there are very sick kids that can pop up.”
Pfizer Inc. and BioNTech SE’s COVID-19 vaccine have been cleared for use in children age 12 to 15 in the U.S., paving the way for the mass vaccination of middle- and high-school students before the next school year.
The Food and Drug Administration said in a statement Monday that it had expanded the shot’s original emergency use authorization to include adolescents 12 through 15 years of age.
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” said Acting FDA Commissioner Janet Woodcock.
Pfizer’s two-shot vaccine was authorized in the U.S. for 16 and up last year. Shots made by Moderna Inc. and Johnson & Johnson are available to those 18 and older. Canada cleared use of the Pfizer-BioNTech shot for adolescents as young as 12 on May 5.
There are almost 17 million people who are 12 to 15 in the U.S., according to the Kaiser Family Foundation, or 5.3% of the U.S. population. Nearly half are people of color.
“When children are vaccinated, they can protect the vulnerable adults in their lives, their grandparents, their aunts and uncles, even their parents who may or may not be able to get vaccinated or who are otherwise immunocompromised,” said Patty Manning, chief of staff at Cincinnati Children’s.
Expanding vaccine access to younger adolescents is expected to accelerate the immunization campaign, as public-health officials seek to curb fast-spreading variants and open schools. Other studies are exploring the vaccine’s use in even younger children. Those are expected to produce data toward the end of this year or early 2021.
“I think it’s very appropriate and very reasonable for parents to be asking questions, they’re looking out for their children, they want that’s best for their children. So they should be comfortable to ask the questions.” said Dr. Robert Frenck, director of the Gamble Vaccine Research Center at Cincinnati Children’s.
Pfizer began recruiting younger adolescents into its final-stage vaccine trial in the late fall, before it secured efficacy results from those 16 and older. That early enrollment work meant the drug-maker was able to evaluate the shot in teens over the holiday season, when new cases of the virus were surging in the U.S., Gruber said.
Eight children took part in a clinical COVID-19 vaccine study at Cincinnati Children’s Hospital Medical Center. The hospital was one of only four in the country doing the Phase 1 review of children ages 5 to 11 on the best dosage of Pfizer’s COVID-19 vaccine.
In March, Pfizer and BioNTech said their vaccine was 100% effective in the 12-to-15 age group in a final-stage trial. In the 2,260 adolescents included in the trial, the shot produced antibodies exceeding the level seen in vaccinated young adults.
All 18 cases of COVID-19 recorded in the study were in adolescents who received a placebo, the companies said. Side effects were consistent with those experienced by 16- to 25-year-olds.
Since 12- to 15-year-olds will be given the same vaccine as adults, the two-shot regimen will be priced the same. In the U.S., the Pfizer-BioNTech vaccine costs $39 for a full course. Currently, the shots are paid for by the U.S. government, with no out-of-pocket cost for vaccine recipients.
If kids are up-to-date on their immunizations, the coronavirus vaccine shouldn’t impact other vaccines, Alter said.
Adults who received the coronavirus vaccine may have experienced some mild side effects, including a sore arm, slight fever or headache.
“The data so far shows it’s the same thing in that 12 to 15 age group,” Alter said.
As a grandfather, he said he has “no questions” that his grandkids will get the vaccine.
“The way a parent or grandparents approaches this is that everything we do in medicine, including vaccines, is a risk versus a benefit,” Alter said. “The risk of this vaccine, of an adverse side effect, is so minimal compared to the benefit of preventing a potentially serious and/or life-threatening disease. To me the vaccine wins out always.”
Questions to ask
If parents have questions about COVID-19 and vaccines, they can call Dayton Children’s COVID-19 Hotline at 1-888-746-5437 with questions from 8 a.m. to 8 p.m.
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