While many parents have heralded the recent news that the Food and Drug Administration (FDA) expanded its authorization for the Pfizer-BioNTech COVID-19 vaccine to also include 12- to 15-year-olds, others have wondered why the organization didn't do so sooner. They've also questioned the safety—and even necessity—of the COVID-19 vaccine for kids.
Sadly, the need to counter false narratives and address misinformation regarding the COVID-19 vaccine is nothing new. "The FDA continues to be transparent and educate the public," says Peter Marks, M.D., Ph.D., the director of the FDA's Center for Biologics Evaluation and Research (CBER) citing the wealth of vaccine information on the FDA website. "Senior staff members from FDA are also conducting outreach by participating in webinars and other meetings to educate the public and respond to questions."
But when it comes to the authorization of the vaccine for kids, more questions have popped up among parents. We spoke more with Dr. Marks to address some of the most common concerns and misconceptions concerning COVID shots for kids. Here's what he wants you to know.
Why did the FDA decide to extend Pfizer's Emergency Use Authorization (EUA) to include 12- to 15-year-olds?
"The FDA reviewed all available data and determined that the Pfizer-BioNTech COVID-19 vaccine met the statutory criteria to amend the EUA (Emergency Use Authorization) and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine's use in this population," says Dr. Marks.
Why wasn't that authorization granted the same time it was authorized for individuals 16 and older?
"Vaccines intended for children are generally tested first in adults, with a step-down clinical development program to include children and infants," he explains. "At the time the vaccine was authorized for people 16 and older, the clinical trials in adolescents were still underway. Once Pfizer had sufficient data supporting the use of the vaccine in an adolescent population, they then requested the EUA be amended to include this younger population."
Are COVID vaccines proven to be as safe and as effective in the 12-15 age groups as they are for individuals 16 and older?
"Available data for the Pfizer-BioNTech COVID-19 vaccine show that the vaccine's known and potential benefits outweigh its known and potential risks in adolescents 12 through 15 years of age," says Dr. Marks. "Out of 1,005 vaccine recipients ages 12 through 15 in the trial, the vaccine showed to be 100 percent effective in preventing COVID-19. Pfizer-BioNTech also provided data that vaccine recipients ages 12 through 15 made immune responses that were similar to or better than those seen in vaccine recipients ages 16 through 25."
Why is vaccinating this age group an important step towards ending the pandemic?
"Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the pandemic," Dr. Marks explains. "The more people who are able to get vaccinated against COVID-19, the closer the country can get to herd immunity and an end to the pandemic."
Should younger Americans who aren't concerned about contracting the disease still become vaccinated against it?
"While COVID-19 is generally milder in adolescents compared to adults, there is still a risk of severe illness," says Dr. Marks. "The sooner we can bring the pandemic under control, the sooner we can return to activities that we've missed out on during this time."
Now that the vaccines are authorized for 12- to 15-year-olds, when can parents expect for authorization to also extend to 3- to 11-year-olds?
"Both Pfizer and Moderna have announced that they are studying their vaccines in pediatric populations under 12 years of age. The FDA cannot predict when or if this age group may receive authorization."
How do you respond to the people who say they want to wait until the vaccines are FDA approved, not authorized, before getting the shots?
"The authorized COVID-19 vaccines have been shown to be safe and effective in a broad population, with over 130 million people in the U.S. fully vaccinated with a very low occurrence of adverse events," says Dr. Marks. "Although an authorization is not an FDA approval, the FDA can assure the public and medical community that we have conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information for every vaccine authorized."
And again, it all comes down to benefit vs. risk. "With science guiding our decision-making, the available safety and effectiveness data submitted for each authorized vaccine support their respective authorizations because the vaccine's known and potential benefits outweigh its known and potential risks. The data provided by the sponsors have met the FDA's expectations. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process."