COVID-19 vaccine approval for kids under 12: 6 things to know

With pediatric COVID-19 cases are on the rise as schools reopen and the delta variant spreads, many are asking when vaccines will be available for children under the age of 12. 

Six things to know: 

1. Two experts said Sept. 12 that vaccines for kids as young as 5 years old could be available as soon as the end of October, The New York Times reported. Scott Gottlieb, MD, former commissioner of the FDA, said in a "best-case scenario" the Pfizer vaccine would be approved for that age group by Halloween. James Versalovic, MD, PhD, the interim pediatrician in chief at Texas Children’s Hospital in Houston, agreed with Dr. Gottlieb, the Times reported. 
   
   
2. Data on how Pfizer's COVID-19 works in children between the ages of 5 and 11 could be ready to submit to the FDA by the end of September, Pfizer CEO Albert Bourla told CNBC Sept. 14. He added that data on how well the shot works in kids as young as 6 months could be available as early as the end of October.
   
   
3. The FDA released a statement Sept. 10 saying that the agency is "working around the clock to support the process for making COVID-19 vaccines available for children."
   
   "As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are anxious about the pandemic and protecting their children," the agency said.
   
   
4. The FDA said that because children are not small adults and are still growing and developing, it's critical to complete robust clinical trials to evaluate the safety and immune response to a COVID-19 vaccine in the age group. The agency said "issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults."
   
   
5. Some drugmakers are still enrolling children in their pediatric vaccine trials, and some are still administering doses or following trial participants, the FDA said. Clinical trials are expected to follow patients for at least two months after vaccinating them to ensure potential safety concerns are detected.
   
   
6. Once a drugmaker submits its data to the FDA, the agency said it will likely complete its review in a matter of weeks rather than months, but said its ability to review the data will depend on the quality and timeliness of the submissions by the drugmakers. The agency said it cannot offer a specific date or timeline for when approval will happen, but assured the public it is working "as expeditiously as possible."