Pfizer Requests FDA Clearance For Vaccine In Kids Ages 12-15

by Erica Gerald Mason
Roberto Jimenez Mejias/Getty

The news comes after Pfizer announces its Covid-19 vaccine is safe and 100 percent effective in suppressing the virus in youth ages 12 to 15

Pharmaceutical company Pfizer requested to expand the use of its Covid-19 vaccine to kids and teenagers ages 12 to 15. The company asks the Food and Drug Administration to amend the emergency use approval, which the FDA originally issued late last year for people ages 16 and up.

The request comes as Covid-19 infections among younger teens and kids are driving outbreaks in some states, NBC News reports. Late last month Pfizer said clinical trials showed its vaccine was safe and 100 percent effective in 12- to 15-year-olds, (the findings have not been peer-reviewed).

Side effects for teens mostly reflected the same as those seen in adults, such as a sore arm, fatigue and headache. “The hope of starting to vaccinate this age group before the start of the next school year,” Pfizer CEO Albert Bourla said in a statement when the results were released.

Pfizer is additionally researching how well the vaccine performs in children ages 6 months to 11 years old. The first dosages in that trial were administered to patients in March.

“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Bourla said.

What’s more, teens in the trial who got the vaccine were later found to have levels of neutralizing antibodies — necessary to wipe out the virus — similar to concentrations in older teens and young adults who had been vaccinated.

Pfizer’s Phase 3 research in adults concluded that the vaccine was around 95 percent efficacious in preventing symptomatic COVID. The percentage lowered slightly to about 90 percent in real-world statistics released earlier this week by the Centers for Disease Control and Prevention.

Dr. Buddy Creech, a pediatric infectious disease expert at the Vanderbilt University Medical Center in Nashville, Tennessee says, “Vaccinating our teenagers is the next step in seeing our way through the pandemic.”

“By extending the age groups that can receive vaccine, we can continue our efforts to protect those that are most vulnerable: older adults as well as adults and teenagers with underlying medical conditions,” Creech says.

As the U.S. works to immunize adults as quickly as possible, getting kids vaccinated is another important piece of the herd immunity puzzle, so any progress in this direction can be seen as a win.