CNN)Clinical trial results of Pfizer/BioNTech’s Covid-19 vaccine showed its efficacy is 100% and it is well tolerated in youths ages 12 to 15, the companies said Wednesday.
BREAKING: The Pfizer-BioNTech coronavirus vaccine is extremely effective in adolescents 12 to 15 years old, perhaps even more so than in adults, the companies announced this morning.https://t.co/t2j6D2TRcP— Apoorva Mandavilli (@apoorva_nyc) March 31, 2021
Pfizer/BioNTech plan 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.
BREAKING: Pfizer says its Covid-19 vaccine is 100% effective in in teenagers aged 12 to 15. https://t.co/I0r3v08RxR— NBC News (@NBCNews) March 31, 2021
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.
Pfizer/BioNTech added that the side effects seen in the young teens were similar to those seen among 16 to 25-year-olds. 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.
Researchers can define a number of antibodies that are a correlate of the protection seen in adults, and then look for that level of antibodies in pediatric participants to know that the vaccine is providing protection. That’s why the Covid-19 vaccine trials in children and adolescents have generally required fewer volunteers than the adult trials.