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BERLIN: BioNTech-Pfizer said on Wednesday (March 31) that their vaccine showed 100 percent efficacy against coronavirus in children ages 12 to 15 as they seek approval for teens to receive the injections before next year. school.
Phase 3 trials conducted in 2,260 adolescents in the United States “demonstrated 100 percent efficacy and robust antibody responses,” the companies said in a statement.
“We plan to submit this data to the (US regulator) FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, in hopes of beginning to vaccinate this age group. before the start of the next school year, “said Pfizer CEO Albert Bourla.
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The CEO of the German company BioNTech said that the results showing high protection for adolescents are “very encouraging given the trends we have seen in recent weeks regarding the spread of the B117 UK variant.”
The BioNTech-Pfizer injection is based on new mRNA technology and was the first COVID-19 vaccine approved in the West late last year.
Both the United States and the European Union have approved its use for people over 16 years of age.
Since then, it has been used by millions of adults in more than 65 countries.
A real-world study involving 1.2 million people in Israel found it to be 94% effective.
With the world scrambling to inoculate, BioNTech said Tuesday it was on track to manufacture 2.5 billion doses of its vaccine this year.
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The increased production was driven by the recent launch of a new production site in the German city of Marburg, which is now one of the largest mRNA vaccine manufacturing plants in the world, he said.
The vaccine is also being produced at a Pfizer plant in Belgium and at three sites in the United States.
BioNTech said improved efficiency and new cooperation agreements with external partners had also helped raise its vaccine target, as had regulatory go-ahead that allows vaccinators to draw six rather than just five doses from a single vial of BioNTech-Pfizer.
BioNTech and Pfizer began studies on the jab in children last week, and the first group of children ages five to 11 received the vaccine.
A younger cohort of children ages two to five is expected to receive their first dose next week in the study, which will also cover children up to six months of age.
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