Most Americans Will Take the Russian Coronavirus Vaccine, if Available Today 
[Thursday, August 13, 2020]
The Russian government made a splash this week by announcing the World’s first approval of a coronavirus vaccine for mass use and, to rub it in, named it “Sputnik V” after the first Soviet satellite that launched the space race. If you set the politics aside and look at the science, the Russian vaccine, if confirmed, could be useful, not just for Russia but others as well. Obviously, corners were cut by the Russians to be the first with an approved vaccine, but it was a calculated gamble, based on logic and broad assumptions regarding the risk and benefits of the vaccine. And if it works, would the public really care about the skipped process? The Russian vaccine is based on replication deficient adenoviral vectors, similar to those being tried by others for coronavirus vaccine, including one vaccine currently in Phase 3 trials. Replication deficient adenoviral vectors are generally considered safe based on published studies from the last decade. Unlike the mRNA vaccines that are the rage of the times but have never been used before, several vaccines based on adenoviral vectors have been allowed in the recent past by the FDA and EMA. The Russian vaccine induces immune response, primarily antibodies, against the coronavirus spike protein, like practically all other vaccines being tested in Phase 2 and 3 trials. The vaccination protocol - first shot followed by a booster after 3 weeks - is like all other coronavirus vaccines in advanced clinical trials. What the Russians did different was that instead of waiting for results from large-scale clinical trials, like the rest of the world, they approved the vaccine based on small safety only studies. Two small Phase 1 studies with a total of 76 healthy volunteers were used to support the safety of the vaccine. The effectiveness of the vaccine in protecting populations will be evaluated post-approval via mass vaccinations outside clinical trials. The rest of the world has criticized this decision as rash, risky, and unethical, but it is not illegal. Under different political circumstances, such an approach may have been allowed even by FDA. A few years ago, during the Ebola outbreak, the FDA allowed treatment with experimental drugs without much clinical trial data. Emergency rules worldwide allow regulators to approve products based on preliminary evidence if the potential benefits out-weigh the perceived risk. The Russians tactfully used the same rules that exist everywhere to their advantage. India is expected to make a similar announcement anytime now and China already approved a vaccine for use by its military. So, the Russians are not alone in trying to race to the vaccine. The US and European approach to evaluate the risk of the vaccine extensively before public release is probably the better scientific approach but the Russian strategy to vaccine based on theoretical safety and efficacy can be justified clinically. Think, if we have a pandemic that has infected millions and killed hundreds of thousands, would we take the Russian approach or the US approach? You can bet that many in the public will go for the quicker approach. There are numerous experiences with life-threatening diseases where patients are willing to take bigger risks and regulators are willing to allow them to do so. The Russian data has not been published and even when it is, we will probably find many issues with it but in the end, it is the overall benefit that will count. If it works, it works. Before we get too carried away by the politics of the news, note, what the Russians did will teach us all which approach to take next time, because if we have not learnt everything we can from this outbreak, we have learnt nothing.