Results of Clinical trial of Pfizer/BioNTech’s COVID-19 vaccine have shown that its efficacy is 100 percent and it is well tolerated in youths from ages 12 to 15.
Pfizer/BioNTech plans to submit the data to the US Food and Drug Administration as soon as possible for expanded emergency use authorization of the two-dose vaccine.
Pfizer reported that in a Phase 3 trial of more than two thousand participants from 12 to 15 years, the vaccine elicited strong antibody responses one month after the second dose, exceeding those demonstrated in people between 16 to 25 years in previous trials.
The vaccine is currently authorized in the US for emergency use in people 16 and older.
Pfizer/BioNTech has said the side effects seen in young teens are similar to those seen among 16 to 25-years.
CEO of Pfizer, Albert Bourla, says there are plans to submit the data to FDA as a proposed amendment to Emergency Use Authorization in the coming weeks and to other regulators globally hoping to start vaccination before the start of the next school year.
Co-Director of the Center for Vaccine Development at Texas Children’s Hospital, Dr. Peter Hotez, said schools can open without vaccinating students, but the vaccines will help.
