The road to vaccine authorization for kids under 5

 
Pfizer-BioNTech

1. Clinical trial

The drug companies compile safety and efficacy data from their clinical trial and ask the FDA to extend the emergency use authorization for the vaccine to this age group.

Application filed (Feb. 1)

2. FDA advisory panel vote

The panel votes on whether the benefits of the vaccine outweigh the risks, based on data from the clinical trial and presentations from federal scientists.

Postponed

3. FDA authorization

The agency weighs the advisory panel vote and decides whether to extend emergency use authorization to this age group.

After the FDA advisory panel vote

4. CDC advisory panel vote

The panel votes on whether the newly FDA-authorized vaccine should be recommended for all children in this age group or only certain subgroups of children.

After the FDA authorization

5. CDC recommendation

CDC Director Rochelle Walensky decides whether to endorse the advisory panel’s decision.

After the CDC advisory panel vote

6. Available to the public

Pediatric shots start going out to pediatricians’ offices and pharmacies.

After the CDC recommendation