First Clinical Trial Results of Russian Vaccine: The Lancet

On Friday, 4 September, medical journal The Lancet published the first peer-reviewed results of phase 1 and 2 clinical trials of Sputnik-V, Russia’s first coronavirus vaccine.

According to The Lancet’s press release, the vaccine “induced a strong immune response in all 76 participants.”

NEW—Preliminary results from Russian trials find that #COVID19 vaccine candidates led to no serious adverse events and elicit antibody response https://t.co/jGUwQa8oNd

Thread (1/8) pic.twitter.com/NWBpWDvUK3

— The Lancet (@TheLancet) September 4, 2020

“Immune response might not be directly proportional to the degree of protection—you can only find this out in large-scale trials.” 

Peter Openshaw, professor of experimental medicine at Imperial College London (London, UK).

On 11 June, Russia became the first country in the world to register a COVID-19 vaccine, despite widespread concerns that the approval was premature as it had not started its phase 3, and thus it’s safety and efficacy were not fully proven. Till these results in The Lancet, Russia did not release any findings from its vaccine trials.

Is It Safe?

“We have no idea whether this vaccine is safe or whether it works. It is really worrying when people start to bypass the standard process we have for vaccine development.”

Ashish Jha, Dean of the Brown University School of Public Health (Providence, RI, USA) in The Lancet press release.

In short, it is too early to tell. For a vaccine to get approved for use, it is usually tested on thousands of volunteers for its safety and efficacy - a step that spans over months. But Russia already approved Sputnik-V before even entering Phase 3 trials.

Bottom line:

We do NOT know if Russian vaccine is safe (small, short-term study only) or effective (does it prevent infection or severe infections)?

Russians "approved" vaccine without knowing if it worked/was safe

This study is good -- but doesn't answer those questions

5/6

— Ashish K. Jha (@ashishkjha) September 5, 2020

Jha adds that the 76 people who showed positive results were already relatively healthy, and it is simply too small a sample size to know enough from.

Given the accelerated pace at which vaccines are being developed, Jha says, “ The difference between doing things correctly and not doing things correctly is a matter of a few months. The middle of a pandemic is not the time to be cutting corners.”

Large-scale clinical trials of the vaccine, involving over 40 000 people, were scheduled to begin in Russia in the last week of August, reports The Lancet.

If the phase 3 trials do not work, it would worsen public perception about vaccines, and people may stop taking these precautions which would worsen the pandemic, warns the journal.