Pfizer and BioNTech announced Thursday that the company has officially asked the Food and Drug Administration to approve its vaccine under an Emergency Use Authorization for use among children ages 5 to 11.
If the request is approved by the FDA, the vaccine will become the first authorized for use among children under the age of 12 in the U.S. and would pave the way for nearly 28 million children to receive a reduced-dose Pfizer shot.
The Pfizer vaccine has emergency authorization for use among 12- to 15-year-olds and is fully approved for everyone over age 16.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer wrote in a statement on Twitter. “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”
The formal EUA request comes about a week after Pfizer submitted data from clinical trials among kids ages 5 to 11 to the FDA for further review. According to the results of clinical trials that included more than 2,000 children, the company reported that a reduced dose (about one-third of the dose given to everyone else) of the vaccine proved to be safe for use among younger children and produced a “robust” antibody response.
Pfizer’s EUA application comes at a time when the nation is seeing a reported uptick in COVID-19 cases among children as a result of the highly transmissible delta variant.
According to the American Academy of Pediatrics, nearly 5.9 million children have tested positive for COVID-19 throughout the pandemic.
While kids are at less of a risk of contracting severe COVID-19 illness compared to older individuals, public health experts say vaccine use among children would offer an added layer of protection against illness.
Dr. Henning Ansorg, the Santa Barbara County public health officer, told the News-Press on Wednesday that children in the 5-to-11 age group make up about 10% of the entire county’s population. He said the county has seen an uptick in cases among younger children recently, largely due to the fact that kids are back in person at school and participating in activities once again.
“Fortunately, most kids don’t get severely ill, but some do,” Dr. Ansorg said. “This is a very protective vaccine, and I think it would help a lot.”
Dr. Ansorg said the data and results from the clinical trials make him “optimistic and hopeful” that the vaccine will help local children stay safe from the impact of the virus. He acknowledged, however, that all vaccines come with risks.
Dr. Ansorg noted some of the COVID-19 vaccines have caused myocarditis among younger people, particularly males between ages 15 to 30. While this could be a concern for parents, Dr. Ansorg said there are more people in the 15-to-30 age group who suffer from heart problems due to contracting COVID-19 than from the vaccine.
“The benefits of the vaccine are overwhelmingly better than their risks,” Dr. Ansorg said, adding that the latest studies have not shown a trend of children having significant problems or reactions to the vaccine.
For parents who may be skeptical of getting their young children vaccinated, Dr. Ansorg said he recommends parents talk with their child’s pediatrician as opposed to going on a “wild goose hunt” on the internet for information.
“It’s really important to get your information from trusted sources, and it’s usually very helpful to talk to your doctor who knows your child and understands the risks and your preferences and can really have a dialogue with you,” Dr. Ansorg said. “That’s my encouragement to parents who are a little unsure or uncertain.”
“Do not just trust anything because it’s printed or published on the internet — there’s just too much unsubstantiated information out there that is frankly false,” he added.
The FDA’s independent advisory panel is expected to review the clinical trial evidence and discuss authorization during a meeting on Oct. 26. If the FDA authorizes emergency use of the Pfizer vaccine among children, it will be up to the Centers for Disease Control and Prevention to review the data and make the final decision before the shots are rolled out.