חיסון פייזר
Pfizer's coronavirus vaccine at a vaccination center in Israel
Photo: AFP
A child in Paraguay receives a coronavirus vaccine

Pfizer submits data for COVID-19 vaccine in children aged 5 to 11

Pfizer-BioNTech makes a formal request after their shot induced a strong immune response in target age group in a clinical trial as American Academy of Pediatrics reports coronavirus infections in children have hit their highest point in September

Reuters |
Published: 09.28.21, 15:29
Pfizer Inc and BioNTech SE on Tuesday submitted initial trial data for their COVID-19 vaccine in children aged 5 to 11 and said they would make a formal request with U.S. regulators for emergency use in the coming weeks.
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  • Coronavirus infections have soared in children, hitting their highest point in early September, according to data from the American Academy of Pediatrics.
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    נער מקבל חיסון לקורונה בפרגוואי
    נער מקבל חיסון לקורונה בפרגוואי
    A child in Paraguay receives a coronavirus vaccine
    (Photo: AFP)
    The vaccine, which is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20.
    The Pfizer-BioNTech vaccine was authorized in kids aged 12-15 roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October.
    A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.
    While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness.
    2 צפייה בגלריה
    חיסון פייזר
    חיסון פייזר
    Pfizer's coronavirus vaccine at a vaccination center in Israel
    (Photo: AFP)
    The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities.
    Data from the companies' trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-to-25 year olds. The safety profile was also comparable to the older age group, Pfizer said.
    The drugmakers are also testing the vaccine in children aged 2-to-5 and those aged 6 months-to-2 years, 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 gained authorization for that age group in Europe.
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