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Does a New Hepatitis Vaccine Cause Heart Attacks?

Discussion in 'Articles' started by Veritas Dolor, Sep 5, 2017.

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  1. Veritas Dolor

    Veritas Dolor vActivist Administrator

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    Author: Milton PackerAugust 02, 2017
    The FDA has a really important question and wants your advice.
    This is not a fairy tale. This is a real-life story.

    Hepatitis B is a serious disease. A company (Dynavax) has a new hepatitis vaccine that induces hepatitis antibodies more vigorously than existing vaccines and does so after 2 doses (instead of the usual 3). The vaccine works through a unique adjuvant. The serological advantages of the Dynavax vaccine were demonstrated in a randomized trial of >8000 patients; about 5600 people received the new vaccine and about 2800 people received the existing standard.

    Why does the FDA need your help?

    In the trial, an acute myocardial infarction occurred in 14 people in the Dynavax group, but in only one person receiving the conventional vaccine. The events were confirmed by adjudication. Since the Dynavax group was twice as large, the risk of acute myocardial infarction in the trial was seven times greater with the new vaccine. The FDA wants to know if the new vaccine should be approved for use in millions of people.

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    Veritas Dolor, Sep 5, 2017
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