Drug makers Pfizer and BioNTech on Wednesday said their COVID-19 vaccine is 100 per cent effective in adolescents of 12-15 years of age.
The companies enrolled 2,260 adolescents of 12-15 years of age in the United States for phase 3 trial. In the trial, 18 cases of COVID-19 were observed in the placebo group as compared with no case in the vaccinated group.
"...the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100 per cent efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated," the companies said in a release, adding that the side effects were generally consistent with those observed in participants of 16-25 years of age.
The companies plan to submit the data from the trial to U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to expand the use of the vaccine in 12-15 years age group. They will also submit the data for scientific peer review for potential publication.
The vaccine has been authorised for emergency use by FDA for individuals aged 16 years and above. It is based on BioNTech's proprietary mRNA technology, and was developed by both BioNTech and Pfizer.
"We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15. We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorisation in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year," Pfizer Chairman and CEO Albert Bourla said.
BioNTech co-founder and CEO Ugur Sahin said the initial results of the trial suggest that children are particularly well protected by vaccination and it will allow them to get back to everyday school life.
The companies are also conducting 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 administering the first dose of the two-dose vaccine to 5-11 years old children last week, they plan to do so for 2-5 years old age group next week.