The FDA recently approved a new hepatitis B vaccine, but it seems there is some trouble in vaccine paradise. According to a new study that MedPageToday reported earlier, the new vaccine is being implicated in causing myocardial infarction issues.
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.
What do you say? What recommendation would you make?
If you think this is just hypothetical, think again. On July 28, 2017, the FDA convened a public advisory committee meeting to consider this exact question. The members of the committee consisted primarily of experts in infectious diseases and immunology. I was the only cardiologist on the committee.If the 14:1 imbalance was due to the play of chance, then the issue of myocardial infarction risk was spurious, and the vaccine should be approved. However, if the 14:1 imbalance reflected a real increase in cardiovascular risk, then approval of Dynavax vaccine would be problematic.
Was it biologically plausible for the new vaccine to cause heart attacks?
The new adjuvant in the vaccine caused an inflammatory response (of uncertain duration), and inflammation is an important cause of rupture of atherosclerotic plaques. So a causal linkage was not out of the question.
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