Pfizer asks FDA to grant emergency use authorization for COVID-19 vaccine in kids aged 5 to 11

Pfizer Vaccine
Posted at 8:31 AM, Oct 07, 2021
and last updated 2021-10-07 18:15:57-04

Pfizer on Thursday formally applied for Emergency Use Authorization (EUA) with the Food and Drug Administration for a smaller dose of its COVID-19 vaccine for use in children aged between 5 and 11.

Thursday's announcement was expected, as just over a week ago, the company submitted Phase 2/3 trial data to the FDA that showed children developed virus-fighting antibodies as well as adults who received two typical shots of the vaccine.

“The side effects were similar than in the older age group, so similar to what we saw in the 12-year-olds, and the immunogenicity was also similar," said Dr. Allison Messina, the chief of the Division of Infectious Disease at Johns Hopkins All Children's Hospital.

ABC Action News spoke to Dr. Messina about why this is an important age group to vaccinate at this point in the pandemic. She explained it'll not only add to herd immunity but also a big reason is these kids have to go to school.

"That is the one place where right now they don’t have a lot of protections, other than masks that they may or may not be mandated to wear, and social distancing, and that can be difficult especially in a crowded classroom," said Messina. "If they want to go to school and interact with their peers, now they have a very protective strategy.”

If you're a parent unsure of what to do, Dr. Messina suggests talking to your child's doctor, who can go over the risks and benefits.

Kimberly Pullen has a 10-year-old daughter and is eager for when a vaccine is ready and approved.

“Every day that I hear we’re a step closer, it gives me a little bit more relief that we’re almost there to getting her vaccinated to keep her safe," said Pullen.

The FDA and the Centers for Disease Control and Prevention will continue to review Pfizer's data. The shots will eventually need approval from the FDA's Vaccines and Related Biological Products Advisory Committee and the CDC's Advisory Committee on Immunization Practices, as well as both agencies as a whole before Emergency Use Authorization is approved. The FDA's advisory committee has a meeting scheduled for October 26.

Pfizer's COVID-19 vaccine already has full approval for people aged 16 and up — the only vaccine thus far to receive full approval in the U.S. The vaccine is currently approved for Emergency Use Authorization for people aged between 12 and 15.

Pfizer said last week that it planned to release data on studies of its COVID-19 vaccine in young children and babies by the end of 2021.