Clinical trial results of the Pfizer/BioNTech COVID-19 vaccine have reportedly showed its efficacy is 100 percent and it is well tolerated in kids aged 12 to 15, the companies said Wednesday, ONA reports citing CNN.
Pfizer/BioNTech plans to submit data to the US Food and Drug Administration as soon as possible for expanded emergency use authorization of the two-dose vaccine.
In a Phase 3 trial of 2,260 participants ages 12 to 15 in the US, the vaccine elicited strong antibody responses one month after the second dose — exceeding those demonstrated in people ages 16 to 25 in previous trials, Pfizer reported. The vaccine is currently authorized in the US for emergency use in people 16 and older.
Researchers observed 18 Covid-19 cases among the 1,129 participants who were given a placebo, and none among the 1,131 volunteers who got the vaccine. The data has yet to be peer reviewed.
The companies added that the side effects seen in the young teens were similar to those seen in those aged 16 to 25.
Common side effects include pain at the injection site, fatigue and fever. The participants will be monitored for protection and safety for two years after their second dose.
Those comparisons to the older population are important, because researchers are building off of the knowledge they gained in the adult trials.