KANSAS CITY, Mo. — Pfizer on Thursday formally applied for emergency use authorization with the Food and Drug Administration for a smaller dose of its COVID-19 vaccine for use in children aged between five 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 about as well as adults who received two typical shots of the vaccine.
Learning the news Pfizer has applied for Emergency Use Authorization for its COVID-19 vaccine in children ages five to 11 is causing relief for some parents but raising questions for others.
Parent Question: If my child has an underlying health condition such as ADHD or anxiety, is there anything additional I should know or ask when deciding whether to vaccinate my five to 11?
Dr. Angela Myers, Children’s Mercy Hospital Infectious Disease Director, Answer: "That’s a great question, lots of kids have ADHD, but so do lots of adults, and again we’ve had millions of people get vaccines who have underlying health conditions, whether that’s ADHD or it's diabetes or it’s heart disease or it’s anxiety or it’s a lot of different things, and we know the vaccine to be safe and effective, so I don’t have any concerns about the parent of a child with ADHD getting the vaccine.”
Myers said the 21-day period before a second dose can be given is expected to remain the same, before adding parents can have their child immunized for influenza and COVID-19 on the same day. In fact, she said it might be easier on both the parent and the kiddo.
Parent Question: How have side effects been for kids ages five to 11 in clinical trials?
Dr. Angela Myers Answer: "That's a great question, so the data hasn't been made available publicly, it's been made available to the FDA at this point, but what Pfizer has said is that the side effects are similar to the routine side effects that occur with the vaccine in adults."
Myers says folks can expect to see that data published in journals, just as it was for adults and older adolescents in previous vaccine trials, after the FDA makes a decision.
Parent Question: What if my four-year-old is just as big if not bigger than a five-year-old? Why can't they be vaccinated if FDA grants EUA?
Dr. Angela Myers Answer: "Here's the thing, there are changes that occur in your body as you grow and develop throughout childhood, and so while those age cut-offs may seem arbitrary, they actually correspond to different changes that are going on in the body with respect to your immune system and your hormones as they change, so in thinking about specifically 12-year-olds are going through puberty and there's changes often times within your body in that time as well, so there is a method to the madness, and I understand why the parent of a four-year-old that looks like a five-year-old or even a six-year-old would want to get their child immunized as soon as possible — I do, but the recommendation will be to stay within the age range for which it was studied."
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.
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 plans to release data on studies of its COVID-19 vaccine in young children and babies by the end of 2021.