20:16 GMT16 June 2021
Listen Live
    Europe
    Get short URL
    208
    Subscribe

    MOSCOW (Sputnik) - The European Medicine Agency (EMA) said on Friday that its committee on vaccine safety asked AstraZeneca to provide additional trial data on its COVID-19 drug for an inquiry into cases of a rare autoimmune disorder following vaccination.

    The Guillain-Barre Syndrome is a condition which causes one's immune system to attack own peripheral nervous system, resulting in such symptoms as numbness, pain and difficulty walking.

    "As part of the review of the regular pandemic summary safety reports for Vaxzevria, AstraZeneca's Covid-19 vaccine, the PRAC [Pharmacovigilance Risk Assessment Committee] is analysing data provided by the marketing authorisation holder on cases of Guillain-Barre syndrome reported following vaccination," the regulator said.

    According to the statement, the disorder was identified during the vaccine's marketing authorisation process as a possible side effect requiring "specific safety monitoring activities."

    "PRAC has requested the marketing authorisation holder to provide further detailed data, including an analysis of all the reported cases in the context of the next pandemic summary safety report," the statement read.

    This is not the first time that the UK vaccine finds itself under scrutiny over side effects. In March, numerous countries suspended the use of this vaccine over blood clotting. While initially the EMA cleared this specific vaccine for use despite the dangerous but "very rare" side effect, in late April it launched a series of inquiries into what causes blood clotting after inoculation with adenoviral vector-based vaccines, such as Vaxzevria.

    Tags:
    vaccine, AstraZeneca
    Community standardsDiscussion