There must be large-scale studies with...

defined negative controls to show without ambiguity that this drug works at safe levels before approved for use. Large trials will also allow evaluation of the extent of adverse events. It may be proven for parasitic infections but it’s still being tested for COVID-19 a very different disease. For vaccines, although the modification to target a new variant may be fast, the modified form needs to go through Phase 1,2, 3 clinical trials all over again and data reviewed at each stage by regulatory bodies, before approval for use.

The hallmark of proof, for safety and efficacy, lies with the double-blinded placebo control phase 3 clinical trials at a large scale (Placebo-Controlled Trials of Covid-19 Vaccines — Why We Still Need

Them, N Engl J Med 2021; 384:e2). For comparison, the Sputnik V and Oxford AstraZeneca vaccines’ blinded placebocontrolled phase three trials, published in peer reviewed journals, had 19866 and 11636 participants respectively in safety and efficacy testing; WHO’s review of the Sinopharm phase 3 results had 16671 participants. These vaccines are now in Phase 4 where there is a significant amount of real time data available, as millions have been vaccinated, showing safety and effectiveness and the continuous monitoring for adverse events post use. Until this standard is met for Ivermectin, it remains unproven. The same for other unproven drugs.

Sincerely,

Jacquelyn Jhingree, PhD