The results of clinical studies with Pfizer / BioNTech’s Covid-19 vaccine showed that its effectiveness is 100% and it is well tolerated in adolescents aged 12 to 15, the companies said on Wednesday.
Pfizer / BioNTech plan to submit the data to the US Food and Drug Administration as soon as possible in order to obtain expanded approval for the emergency use of the two-dose vaccine.
In a phase 3 study of 2,260 people aged 12 to 15 years in the United States, the vaccine elicited strong antibody responses one month after the second dose, higher than those seen in previous studies in people 16 to 25 years old Years ago, Pfizer / BioNTech reported. The vaccine is currently approved in the United States for emergency use in people aged 16 and over.
The researchers observed 18 cases of Covid-19 among the 1,129 participants who were given a placebo and none among the 1,131 participants who were given the vaccine. The data still needs to be peer-reviewed.
Pfizer / BioNTech added that the side effects seen in people aged 12-15 years were similar to those seen in 16-25 year olds. Participants will be monitored for safety and safety two years after their second dose.
“We share the urgency to expand our vaccine approval to younger populations and are encouraged by clinical trial data from adolescents 12-15 years of age,” said Albert Bourla, CEO of Pfizer.
“We plan to submit this data to the FDA and other regulatory agencies around the world in the coming weeks as a proposed change to our emergency clearance in the hopes of starting vaccination for this age group before the start of the next school year.”
A separate Phase 1/2/3 study of the Pfizer / BioNTech vaccine in children aged 6 months to 11 years was started last week when the first participants, aged 5 to 11 years, received a shot.
Pfizer / BioNTech plans to begin dosing in 2- to 5-year-olds next week and up to participants ages 6 months to 2 years old. The company plans to enroll 4,644 children in the study and expects results by the end of 2021.
Moderna is also testing its Covid-19 vaccine in adolescents and children in two clinical trials with children aged 12 to 17 years and children aged 6 months to 11 years.
Read more here: