The thing about this trial is that it will never be ethical because it is addressing a scientifically useless question: do non-specific effects (NSEs) of combining inactivated vaccines like hep B with live attenuated ones like BCG (TB vaccine) impact all-cause mortality?

NSEs are real. Vaccines (and infection) do induce broad immune and inflammatory responses that are not limited to the pathogen. My lab studies the host response to infection and vaccination. I see NSEs occur when I look at gene expression data. Whether they are real is not the question; it’s whether they actually impact health.

There is no evidence showing that combining different vaccines cause NSEs that are clinically harmful or have enough impact to increase all-cause mortality over years, which is what this study is measuring.

Studies on NSEs in Guinea-Bissau are impacted by the exceptionally high child and maternal mortality rate. When a lot of kids die anyway, it’s easier to find a signal. The problem is, it’s also easy to get false positives against such a high background. NSE studies in developed countries have not found causal associations between combined vaccines and all-cause mortality. Although it’s harder to see a signal because background mortality is much lower, if one is there it is more likely to be the real thing. And there isn’t one.

All studies that are scientifically pointless are unethical. I disapprove of my tax dollars being awarded without review to exploit poverty, put babies at risk of an incurable cancer-causing infection, and manufacture data justifying the unsupported decision to deschedule the birth dose of the HBV vaccine. This trial should not occur.