ST. LOUIS — Pfizer announced Monday morning that its vaccine is effective and safe for children between 5 and 11 years old. The dose the vaccine developer is testing for ages 5-11 is one-third the amount currently FDA approved for adults.
About 2,200 children took part in the initial Pfizer COVID-19 vaccine study. The participants received either one dose, two doses separated by a few weeks or a placebo. Pfizer says based on results, their vaccine works.
"Oh we are so excited," Patricia Dubos with Olympia Gymnastics tells 5 On Your Side. "It will mean that we will no longer, fingers crossed, have as many kids quarantine if we have a positive case in a class and it has happened."
The vaccine is not available yet, but Pfizer is taking the first steps. SLUCare Infectious Disease Physician Dr. JoAnn Jose details Pfizer's announcement.
"They have internal data for 5- to 11-year-olds that they feel demonstrates a high degree of efficacy, as well as safety, and they will be applying for emergency use authorization from the FDA for that age group for their vaccine," she said.
It is unclear if Pfizer has sent its data to the Food and Drug Administration for approval, here is a breakdown of what happens next:
- FDA reviews the data and submits it to an external advisory program
- FDA's external advisory program reviews and sends findings back to FDA
- FDA makes an official recommendation and forwards to CDC
- CDC reviews and decides on approval or denial
It sounds like a long process, but Washington University Pediatric Infectious Disease Specialist Dr. Jason Newland told 5 On Your Side that might not be the case.
"Sounds like it could take forever. I don't think that is the case. I actually believe that by the end of October they'll have that external advisory committee and hopefully by sometime in November, we will have an authorization to give vaccine in children 5-11 years of age."
Dr. Newland is optimistic that the vaccine will be available for children under 5 by 2022.
If approved, Dr. Jose wants parents to include their kids in the vaccine conversation.
"If you are asking your child to get a shot, it makes sense to explain what that shot is supposed to do and the moment that they're living in," she said. Children have experienced an incredible amount of disruption over the two years that we've had this pandemic and it makes sense to involve them in the journey towards solving it."