Early Russian Covid-19 Vaccine Results

A new article in the Lancet, a British medical journal, discusses some of the early results that were seen with the Russian Covid vaccine. The results are from the Phase I and II trials. Phase I trials is the initial introduction of an experimental drug or therapy to humans. This phase is the first step in the clinical research process involved in testing new or experimental drugs. Roughly 70% of new drugs make it to Phase II trials which involves several hundred participants. Usually the participants have a condition that the new medication is meant to treat. They’re usually given the same dose that was found to be safe in the previous phase. Drugs/vaccines successful and safe then USUALLY go to Phase III trials which usually involves up to 3,000 participants . Trials in this phase can last for several years.The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition. To move forward with the trial, investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options.

This is the first report of those Phase I and II trials from Russia which included 76 participants. There were actually 2 variations of their vaccine that were tested and both were similar. On August 12, 2020 Russia made the highly unusual decision to essentially forego Phase III trials and approved their Covid vaccine for use. The good news is that the vaccine induced a strong immune response in all 76 participants. The question is how strong of an immune response did it provoke. That would be more clear with the larger number of participants that usually would be in the Phase III trials. But Russia expects 40,000 to participate in essentially a continuation of the trials. They call their vaccine “Sputnik V”. Sputnik was the first orbitting satellite and was the beginning of the space race.

So how did their vaccine do in immunity testing? The most common adverse events were pain at injection site (44 [58%]), hyperthermia (38 [50%]), headache (32 [42%]), asthenia (21 [28%]), and muscle and joint pain (18 [24%]). Most adverse events were mild and no serious adverse events were detected. All participants produced antibodies to SARS-CoV-2 glycoprotein.  Other immunity markers such as T-cells were detected in all participants by day 28. All of these are promising and Russia stated that further investigation of the effectiveness of this vaccine for prevention of COVID-19 is needed.

Why did Russia skip Phase III? Probably nationalism has a lot to do with it. They predict being able to produce up to 500 million doses/ year. Russia has received international requests for 1 billion doses of its vaccine. The USA has purchased 100 million doses of Moderna’s mRNA vaccine candidate and 300 million doses of Astrazeneca’s adenovirus vector vaccine. Vaccines are big business and the Covid vaccine may be the biggest ever!

So is it safe? Well no one reportedly died from it. Pretty typical side effect profile you might see with some flu vaccines. If all I had to deal with was a “flu-like” illness for a few days with good assurance that it wasn’t lethal I would certainly strongly consider it. Would I take the Russian vaccine. Not yet…..I don’t think they gained that much by releasing it this early and Phase III testing would have only added a few months. The results are encouraging though. One fear is how strong is the immunity and how long will it last. We’re not even sure if HAVING HAD Covid provides long term immunity. There are 9 vaccines all at around the same point of development. Let’s keep our fingers crossed that the truly amazing progress that’s been made in such a short time continues to be positive.