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Sputnik V’s ugly cousin Clinical results for Russia’s EpiVacCorona vaccine are finally here, but developers published in an obscure local journal, raising questions and concerns

Source: Meduza
Vlad Nekrasov / Kommersant

As the drug’s developers promised in a recent interview with Meduza, we now have a peer-reviewed scientific article that makes the case for EpiVacCorona, Russia’s latest coronavirus vaccine. Though the research didn’t arrive until March 25, the drug itself won regulatory approval back in October 2020 and has been available to Russian patients outside clinical trials for months. Until yesterday, the only public information about the vaccine was limited to two patents, several statements by Russia’s consumer protection agency (which controls the institute that developed EpiVacCorona), and a few interviews with the drug’s creators. Unfortunately, the long-awaited evidence leaves much to be desired. Notably, scientists released the article in a little-known Russian journal called Infection and Immunity, despite indications from health officials that the research would appear in a more authoritative outlet like The New English Journal of Medicine or The Lancet (which published the first peer-reviewed evidence for the “Sputnik V” vaccine). Meduza reviewed the EpiVacCorona article and asked three experts to assess its strengths and weaknesses.

What do we finally know about this vaccine?

The published research concerns EpiVacCorona’s combined Phase I and II trials (involving 14 and 86 volunteers, respectively), meaning that the data reflects only the drug’s short-term safety and side effects, as well as its ability to provoke an immune response in patients. These experiments weren’t designed to test the vaccine’s effectiveness, which can’t be assessed until the end of Phase III, which involves 3,000 participants.

According to the data released in Infection and Immunity, no one who received EpiVacCorona suffered any major adverse reactions, but serious questions remain about the vaccine’s immunogenicity, which became an issue even before the article was published, thanks to an independent review of blood samples shared by several “enthusiasts” participating in the drug’s clinical trials. Worryingly, the independent experts found none of the “neutralizing antibodies” needed to protect against COVID-19, and even common antibodies were far less present than expected. 

The new article from EpiVacCorona’s creators shows that researchers avoided the Russian government’s own recommended test for measuring neutralizing antibodies and opted instead for two other tests, one of which is completely unknown. Also, the article’s data about neutralizing antibodies inexplicably begin only 35 days after patients received their shots. The results show that vaccinated participants did develop neutralizing antibodies, but so did members in the control group, strangely, recording levels roughly five times lower. For some reason, patients who received the placebo also recorded falling levels of common antibodies, as the trials progressed, suggesting potential flaws in the testing. The study’s authors do not even try to explain this.

Here are few more oddities:

  • One of the study’s participants became infected with the coronavirus, 47 days after being vaccinated. While one case of COVID-19 says nothing about EpiVacCorona’s effectiveness, it’s nevertheless concerning to see the drug fail in a test with such a small sample size.
  • Researchers offer no hard data measuring any immunity components besides antibodies, such as T-cell response, cytokines, and so on. (This is in stark contrast to the data published earlier by Sputnik V’s creators.)
  • There are several blatant typos in the article, including references to “two vaccinated groups” (where one is a placebo group), and another passage about antibody analysis that mentions animal testing (instead of human testing).

What do we know about the journal that published the article?

It’s unclear why EpiVacCorona’s developers published their research in a little-known Russian scientific journal. On February 10, Russia’s consumer protection agency, Rospotrebnadzor, indicated that the article would appear in a major Western publication, explaining that the study is too important to limit to a domestic audience. Not only is Infection and Immunity a relatively obscure outlet, but it’s also co-founded by the St. Petersburg Pasteur Institute — a subsidiary of Rospotrebnadzor Institute, which developed EpiVacCorona) — raising questions about the publication’s reliability as an independent reviewer. In fact, according to available records, the entire review process was completed in less than two weeks.

Background

EpiVacCorona’s race to the finish line Meduza speaks to the developer and manufacturer about concerns surrounding Russia’s latest coronavirus vaccine

Background

EpiVacCorona’s race to the finish line Meduza speaks to the developer and manufacturer about concerns surrounding Russia’s latest coronavirus vaccine

What are experts and participants saying about this research?

Konstantin Severinov, principal investigator at the Waksman Institute and a professor of molecular biology and biochemistry at Rutgers University

Dr. Severinov told Meduza that releasing EpiVacCorona’s early trial results in a little-known Russian medical journal is worrying, and he says the publication’s relationship with Rospotrebnadzor risks a conflict of interest. The results show that the vaccine does apparently boost patients’ antibody levels, but Severinov notes that the test needed to measure these antibodies is produced by EpiVacCorona’s own developers at the Vector Institute. No one else can recreate these results, moreover, because the published research doesn’t identify the artificially synthesized viral-protein fragments (peptides) used in the vaccine.

“There’s no data about its effectiveness, meaning that we have a situation where EpiVacCorona is circulating among the general public and people are already getting the vaccine and starting to act like they’re already vaccinated, which is unacceptable, in my view,” says Dr. Severinov.

In light of Rospotrebnadzor’s failure to provide adequate information for comparing Russia’s different coronavirus vaccines, Severinov says the country needs more independent efforts to analyze the blood work of trial participants. “I think this kind of volunteer work is beautiful,” he told Meduza.

Dmitry Kulish, professor at Skoltech's Center for Entrepreneurship and Innovation, specializing in pharmaceutical business development

There is no explanation, says Dr. Kulish, for how EpiVacCorona’s creators recorded a 100-percent seroconversion (the time period during which a specific antibody develops and becomes detectable in the blood), while an independent study of the several trial participants didn’t detect this. Instead, the article in Infection and Immunity establishes the drug’s immunogenicity according to a “secret test” developed by the Vector Institute itself. “When the ‘Materials and Methods’ section doesn’t describe the test used to reach the article’s most important finding, it’s drivel from a scientific point of view,” says Kulish.

The article also lacks any information about how Vector’s mysterious test processes former COVID-19 patients. “If their secret test doesn’t ‘see’ those who have recovered, it automatically means the vaccine is only provoking an immune response to some nonsense that has nothing to do with the disease,” explains Dr. Kulish.

Denis Lagutkin, EpiVacCorona clinical trial participant and molecular biologist

Lagutkin told Meduza that the main problem with EpiVacCorona’s published research is that its authors claim to have achieved virus neutralization in Vero cell cultures, but four independent laboratories studied roughly 60 samples from clinical-trial participants and got back negative results in every case.

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Story by Alexander Ershov

Summary by Kevin Rothrock

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