Pfizer-BioNTech COVID-19 vaccine demonstrated 100 percent efficacy and strong antibody responses in a Phase 3 trial in adolescents, 12 to 15 years of age, the pharmaceutical giant said on Wednesday in a statement indicating teenagers can now be vaccinated.
The drugmaker says the results from the trial in 2,260 adolescents exceed those recorded earlier in vaccinated participants aged 16 to 25 years old and was well tolerated.
The clinical trial found no symptomatic infections among the vaccinated children and there were no serious side effects.
“We share the urgency to expand the authorization 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,” said Albert Bourla, chairman/CEO, Pfizer.
“We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization 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.”
The findings, if they hold up, may speed a return to normalcy, especially in countries most affected by the virus.
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The companies plan to submit these data to the FDA and EMA for a requested amendment to the Emergency Use Authorization of the vaccine and the EU Conditional Marketing Authorization to expand use in adolescents 12-15 years of age as quickly as possible.
All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Pfizer and BioNTech also plan to submit the data for scientific peer review for potential publication.
Study in Children 6 months to 11
Last week, the biopharmaceutical companies dosed the first healthy children in a global Phase 1, 2 and 3 studies to further evaluate the safety, tolerability, and immune-boosting ability of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 11 years of age.
The study is evaluating three age groups: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years. The 5 to 11-year-old cohort started dosing last week and the companies plan to initiate the 2 to 5-year-old cohort next week.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA) but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent COVID-19 for use in individuals 16 years of age and older.
The vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorizations Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.
