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    Home > Active Ingredient News > Infection > Nature: It is so difficult to investigate rare side effects of COVID vaccine

    Nature: It is so difficult to investigate rare side effects of COVID vaccine

    • Last Update: 2021-04-16
    • Source: Internet
    • Author: User
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    In mid-March, some European countries suspended the distribution of the COVID-19 vaccine produced by the University of Oxford in the UK and the pharmaceutical company AstraZeneca .


    COVID-19 Thrombosis Management

    These events show how challenging it is to prove that the medical problems after immunization (the so-called adverse reactions) are caused by the vaccine itself.


    immunity

    Doctors worry that the anti-vaccine movement will exacerbate some communities' hesitation about vaccines.


    Correlation is not causation

    Correlation is not causation

    Ideally, adverse events should be directly related to the use of specific laboratory-tested vaccines.


    It is particularly challenging to prove whether the adverse reaction is really caused by the vaccine, especially when the reaction occurs a few days or weeks after vaccination.


    Ten years of mystery

    During the 2009 H1N1 flu (or swine flu) pandemic, public health agencies in Sweden and Finland warned of narcolepsy (a chronic, debilitating sleep disorder) in children who took a dose of the H1N1 vaccine Pandemrix Incidence rate is rising.


    child

    The researchers compared the background incidence of narcolepsy in seven countries with the incidence of Pandemrix and two other adjuvant-containing H1N1 vaccination groups.


    consensus

    Rare event

    Rare event

    As far as the COVID-19 vaccine is concerned, before the government approves its widespread use, the vaccine that is currently being launched has undergone clinical trials with the participation of thousands of participants.


    But even the largest clinical trials are not designed to detect extremely rare side effects, which may occur in less than 1 in every 10,000 vaccinations.


    In the United States, the National Institute of Allergy and Infectious Diseases has begun to organize a clinical trial to understand the allergy risk of the mRNA-based COVID-19 vaccine.


    In Europe, EMA is convening a pharmacovigilance risk assessment committee meeting to further investigate the rare coagulation disorder found in a very small number of people using AstraZeneca vaccine, and will announce the findings in early April.


    Better monitoring

    Better monitoring

    Currently, public health agencies track potential side effects through reporting systems, such as the World Health Organization’s platform VigiBase, EMA’s EudraVigilance, and the United States’ vaccine adverse event reporting system.


    An active surveillance system can collect adverse event data (including background rates and post-vaccination data) from electronic health records without relying on people to directly report these data, thereby gaining a more comprehensive understanding of vaccine safety.


    The combination of active surveillance and targeted clinical trials is not only important to ensure that the current combination of active surveillance and targeted clinical trials is not only important to ensure the safety of the current COVID-19 COVID-19 vaccine.


    Remmel, Ariana.


    Remmel, Ariana.




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