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    Home > Active Ingredient News > Infection > The Pfizer vaccine has been recognized by the FDA as a breakthrough therapy, and pregnancy vaccination can benefit both mother and baby

    The Pfizer vaccine has been recognized by the FDA as a breakthrough therapy, and pregnancy vaccination can benefit both mother and baby

    • Last Update: 2022-09-21
    • Source: Internet
    • Author: User
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    ▎ WuXi AppTec content team editor

    Not long ago, Pfizer announced that its research streptococcal b vaccine candidate, GBS6 (PF-06760805), has been recognized as a breakthrough therapy by the US FDA to prevent invasive streptococcus b (GBS)




    It is understood that the FDA's final opinion was based on the results of an interim analysis of a placebo-controlled Phase 2 clinical trial (NCT03765073) that evaluated the safety and immunogenicity of GBS6 in healthy pregnant women aged 18 to 40 who were vaccinated against GBS6 in the early stages of the second or third trimester



    Streptococcus b is a common bacterium that can cause potentially serious illnesses, including sepsis, pneumonia, and meningitis



    During pregnancy, antibodies are transferred from the mother's blood through the placenta to the fetus, a natural process known as "placental antibody transfer", and the treatment strategy relies on this transplacental antibody transfer process



    Image credit: 123RF


    GBS6 is a maternal vaccine that Pfizer is developing to help prevent GBS infection in



    "GBS infection can have a devastating impact on newborns and their families," Dr.



    Image credit: 123RF


    Dr Anderson further added: "If approved for use in pregnant women, GBS6 can help protect newborns from serious diseases caused by this pathogen, such as meningitis, pneumonia and sepsis, which meets the critical needs of


    Resources:

    [1] FDA Grants Breakthrough Therapy Designation to Pfizer’s Group B Streptococcus Vaccine Candidate to Help Prevent Infection in Infants Via Immunization of Pregnant Women,Retrieved Sep 8th 2022, fromWuXi AppTec's content team focuses on the global biomedical health research process
    .

    This article is for informational purposes only and the views expressed herein do not represent the position of WuXi AppTec, nor do they represent WuXi AppTec's support for or opposition to the views
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