COVID-19: Pfizer-BioNTech vaccine 100% (*12*) in 12 to 15-year-olds, say companies
Section 3 trials carried out on 2,260 adolescents in america “demonstrated one hundred pc efficacy and strong antibody responses”, the companies stated in a press release.
“We plan to submit these knowledge to (US regulator) FDA as a proposed modification to our Emergency Use Authorisation in the approaching weeks and to different regulators around the globe, with the hope of beginning to vaccinate this age group earlier than the beginning of the following faculty 12 months,” stated Pfizer chief govt Albert Bourla.
Chief govt of German firm BioNTech stated the outcomes exhibiting excessive safety for teenagers had been “very encouraging given the tendencies we now have seen in latest weeks concerning the unfold of the B.1.1.7 UK variant”.
The BioNTech/Pfizer shot is predicated on novel mRNA expertise and was the primary COVID-19 vaccine to be accepted in the West late final 12 months.
Each america and the European Union have accepted its use for folks aged 16 and above.
Since then, it has been used in hundreds of thousands of adults in greater than 65 international locations.
An actual-world examine involving 1.2 million folks in Israel discovered it to be 94 p.c (*12*).
With the world scrambling to inoculate, BioNTech stated Tuesday it was on observe to manufacture 2.5 billion doses of its vaccine this 12 months.
The upper output was pushed by the latest launch of a brand new manufacturing web site in the German metropolis of Marburg, which is now one of many world’s largest mRNA vaccine manufacturing vegetation, it stated.
The vaccine can be being produced at a Pfizer plant in Belgium and at three websites in america.
BioNTech stated improved effectivity and new cooperation agreements with outdoors companions had additionally helped elevate its vaccine goal, as had the regulatory nod permitting vaccinators to extract six as an alternative of simply 5 doses from a single BioNTech/Pfizer vial.
BioNTech and Pfizer final week started research of the jab on youngsters, with the primary group of five-to-11-year-olds getting the vaccine.
A youthful cohort of two-to-five-year-olds is anticipated to get their first dose subsequent week in the examine which can even cowl youngsters as younger as six months outdated.
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