Pfizer Inc and BioNTech SE on Tuesday presented preliminary trial data for their COVID-19 vaccine in children aged 5 to 11 and said they would make formal requests with US regulators for emergency use in the coming weeks.
According to data from the American Academy of Pediatrics, coronavirus infections among children have increased, reaching its highest point in early September.
The vaccine, which is already authorized in adolescents 12 to 15 years of age and fully approved for 16 years and older, showed a strong immunity in the target age group in a 2,268-participant clinical trial. prompted the response, the companies said on September 20.
The Pfizer-BioNTech vaccine was authorized in children aged 12-15 years, about a month after the companies filed for authorization. If the same time-frame for this application is followed, young children could start getting their shots as late as October.
A speedy authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.
While children are less vulnerable to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of serious illness.
The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities.
Data from the companies’ trial showed that the two-shot vaccine produced an immune response in children, similar to that previously seen in 16 to 25-year-olds. Pfizer said the safety profile can also be compared to the older age category.
Drugmakers are also testing the vaccine in children 2 to 5 years of age and 6 months to 2 years of age, with data expected in the fourth quarter.
Moderna’s COVID-19 vaccine is not yet authorized for use in adolescents in the United States, while it has received authorization for that age group in Europe.
(Reporting by Manas Mishra in Bengaluru; Editing by Soumyadev Chakraborty)
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