With the global COVID-19 case count reaching 20 million, Russia has approved a vaccine for the disease. There is, however, suspicion around the approval since the trials have yet to conclude the Phase 3 testing. To solidify the vaccine approval, Russian President Vladimir Putin, stated the vaccine is working “effectively enough”- far too vague for most medical professionals throughout the world. What does “effectively enough” constitute? With the vaccination trials being rushed already through the world, how many corners are being cut by the nations at the head of the vaccination development? Like many questions that hint toward political gains and propaganda, we may never truly know the answer to how many corners are being cut on a vaccination approval that could indeed affect the entire globe for better or worse.
Russia has proceeded to approve the vaccination despite the World Health Organization’s best advice to stay true to the clinical trial methodology. Putin has stated that one of his children did receive the vaccination.
It is worth noting that the clinical trials include testing in 3 phases. Phase 1 and 2 are conducted with relatively small groupings, while the third phase can include tens of thousands of participants in a highly controlled and regulated study. During phase 3, there is a great opportunity, with such a large participation pool, to truly understand the placebo effect as compared to the actual vaccination. For a reference point, the U.S. FDA would require 50% or bett
er efficacy during phase 3 studies to pass on to the next phase. To be clear, that is 50% more effective than a placebo, which is by the very nature of the name, nothing. This begs the question, with how strict the U.S. is perceived for clinical trials, how strict is Russia? Being the 1st to the trough is not key in this COVID-19 world, it is the 1st to the trough with efficacy.
https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
https://www.theverge.com/2020/8/11/21363135/russia-coronavirus-vaccine-unproven-registration
https://www.nytimes.com/2020/08/11/world/coronavirus-covid-19.html
