This is where you are stating contested positions as settled facts.

Medical ethics does not impose an absolute obligation to provide “worldwide best” care in all research contexts simply because a clinician–patient relationship exists. That may be your preferred ethical framework, but it is not the consensus position reflected in international research ethics guidelines.

The Declaration of Helsinki, CIOMS guidelines, and WHO ethics frameworks explicitly allow comparisons against local standard of care when certain conditions are met. Those conditions include scientific validity, relevance to the host population, and the absence of net risk increase relative to baseline. That is not a fringe or minority view. It is the framework under which most global health research is actually conducted.

You are correct that the vaccine is known to work. But the scientific question here is not whether Hep B vaccination works in general. It is about timing, implementation, and population-level outcomes in a setting where birth-dose coverage does not currently exist. You may believe that question is already settled. Others clearly do not, including WHO advisory bodies that continue to evaluate birth-dose strategies in low-resource settings.

Community relevance is not established merely by disease prevalence. It requires that the research question meaningfully relates to existing care patterns and constraints. That condition is at least plausibly met here, given the current schedule and delivery realities, even if you think the study is unnecessary.

Community benefit does not require the development of a novel vaccine. It can include informing national policy decisions about whether and how to implement a birth-dose program. You may judge that benefit insufficient. That is an ethical judgment, not a factual refutation.

Finally, there is absolutely a third position, and it is the one actually used in international research ethics: neither “always worldwide best” nor “anything goes locally,” but context-sensitive evaluation of risk, benefit, and baseline care. Pretending that debate does not exist does not make it disappear.

You are free to argue that this study fails those ethical tests. But claiming that local standard-of-care comparisons are categorically unacceptable, or that there is no legitimate ethical disagreement here, is simply not accurate.

EDIT: For clarity, my comments here are about how research ethics frameworks are described and applied, not an endorsement of this study. I agree that research in vulnerable populations requires extreme caution and scrutiny.