Pfizer Pharmaceuticals and its BioNTech partner have asked the Food and Drug Administration (FDA) for emergency use authorization for its COVID-19 vaccine to be used in children ages 5 to 11.
If approved, the pediatric vaccine would protect more than 28 million people in the US alone.
“With new cases in children in the US continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer said in a statement. “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”
The proposed dose will equal one-third of the adult dosage of vaccine, which would require either dilution or a new syringe entirely. As with adults, a second dose would need to be administered three weeks after the first.
Children ages 12 and up are already receiving the vaccine in the United States and in Israel.
In its submission, Pfizer BioNTech is expected to describe the administration method it intends to use with the vaccine for young children.
The FDA has scheduled a meeting October 26 to consider the request. The two companies said they are submitting data to support the application, and a ruling is expected sometime between the end of this month and Thanksgiving.
Acting FDA Commissioner Dr. Janet Woodcock noted last week in a statement regarding the new application that “a different dosage or formulation from that used in an older pediatric population or adults,” may be required.
Nearly 30,000 children were admitted to hospitals with the Delta variant of COVID-19 in August alone. Some 125 children ages 5 to 11 have died from the virus.
According to the American Academy of Pediatrics, children comprised one in four Americans – more than 173,000 – who became infected with the virus last month, equaling almost 27 percent of all cases in the country. Nearly 5.9 million children have tested positive for COVID-19 since the start of the pandemic.
Israel’s Health Ministry has already authorized the coronavirus vaccine for children ages 5 to 11 who have serious underlying medical issues, and who may be more vulnerable to the virus. The dose for young children will be the Pfizer BioNTech vaccine, 1.0 milliliters rather than the regular 3.0 ml.
Only individual children with a “high probability of serious illness and even death following infection with the novel coronavirus” are to be inoculated, the ministry said, adding that authorization for those doses must be granted by the healthcare provider, and then validated by the ministry.
Medical conditions that could qualify for such an authorization include severe autoimmune diseases, severe chronic lung illness, neurodevelopmental disorders, congestive heart failure, sickle cell anemia and extreme obesity (BMI in the 99th percentile and above for age and sex). Even after approval is rendered, the ministry said the final decision remains with the parents.