Drug makers Pfizer and BioNTech said Wednesday that their COVID-19 vaccine is 100 percent effective in teenagers ages 12-15.
The companies enrolled 2,260 adolescents aged 12 to 15 in the US for the Phase 3 study. In the study, 18 cases of COVID-19 were observed in the placebo group compared to no case in the vaccinated group.
“… the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100 percent efficacy and robust antibody responses in excess of those previously recorded in vaccinated participants aged 16-25 and was well tolerated,” said the company in a press release. The side effects were generally consistent with those seen in participants aged 16-25 years.
The companies plan to submit the data from the study to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to expand use of the vaccine in the 12-15 age group. You will also submit the data for scientific review for possible publication.
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The vaccine has been approved by the FDA for emergency use for people aged 16 and over. It is based on BioNTech’s proprietary mRNA technology and was developed by both BioNTech and Pfizer.
“We share the urgency to expand our vaccine approval for use in younger populations and are encouraged by clinical trial data in adolescents 12-15 years old. We plan to present this data to the FDA as a proposed change to our emergency Use the.” Approval in the coming weeks and from other regulators around the world in the hope of starting vaccinating this age group before the start of the next school year, “said Albert Bourla, chairman and CEO of Pfizer.
BioNTech co-founder and CEO Ugur Sahin said the initial results of the study suggest that children are particularly well protected with vaccinations and that they can get back to school.
The companies are also conducting a Phase 1/2/3 study to further evaluate the safety, tolerability and immunogenicity of the vaccine in children aged 6 months to 11 years. While they started giving the first two-dose dose of the vaccine to children ages 5-11 last week, they plan to do so next week for the 2-5 age group.
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