Will covid-19 vaccines save lives? Current trials aren’t designed to tell us
BMJ Feature notes none of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths, nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.
Source:
British Medical Journal
SPS commentary:
Editorial notes that following months of campaigning for greater openness, four manufacturers have made their full study protocols publicly available, thus creating a rare opportunity for “real time transparency” in which the conduct of clinical trials is opened to public scrutiny while the studies are still under way. It stresses that the covid-19 vaccine protocols should be scrutinised by the widest possible readership, to open a critical discussion of many questions about their design and conduct. These include why children, immunocompromised people, and pregnant women have been excluded from most trials; whether the right primary endpoint has been chosen; whether safety is being adequately evaluated; and whether gaps in understanding of the clinical implications of pre-existing T cell responses to SARS-CoV-2 are being addressed.