Worse than ineffective

Two independent studies have confirmed that EpiVacCorona is a worthless vaccine — and it should be taken off the market

Despite a recent report that Russia’s Health Ministry has stopped placing orders of the EpiVacCorona vaccine, its manufacturer is optimistic and claims to expect the next production order to come in February. Meanwhile, scientists, as well as journalists at Meduza, have obtained convincing evidence that EpiVacCorona is ineffective and gives recipients a completely false sense of security (unlike Sputnik V, which has been proven to protect recipients from COVID-19’s most severe effects). Meduza explains the two studies that led to that conclusion.

EpiVacCorona is a peptide vaccine against COVID-19 created by Rospotrebnadzor’s Vector Research Center and registered by the Russia Health Ministry on October 13, 2020, without having undergone clinical effectiveness trials. It’s still unclear to what extent the vaccine provides protection to its recipients, even if you only look at data provided by its manufacturer: the studies meant to answer this question began in late 2020, but the results haven’t been published in any academic articles — nor anywhere else.

The only academic article EpiVacCorona’s developers have published concerning the effects of their vaccine on humans (the other one is about hamsters) was published in a little-known Russian journal called Infection and Immunity, which belongs to Rospotrebnadzor, Russia’s federal consumer protection agency. Rather than reporting data on the vaccine’s effectiveness, the published article focuses on the vaccine’s immunogenicity — its ability to stimulate antibody development. However, even this indirect information (which contains a number of methodological failures) is directly contradicted by a different, independent study of the blood serum of volunteers who received the vaccine. How effective EpiVacCorona really is is currently anyone’s guess. Nonetheless, the vaccine is still being produced and given to people in Russia — especially outside of Moscow.

Meduza has independently analyzed the effects of EpiVacCorona and other Russian vaccines using infection rate data from Moscow in the summer of 2021. The results of the analysis confirm that something many people have long suspected but nobody has been able to prove statistically: EpiVacCorona is an ineffective vaccine; moreover, it may actually be harmful, since it gives recipients a false sense of security, thereby increasing Russia’s COVID-19 infection rate.

The data used in the analysis was provided by a source who has access to Moscow’s infection monitoring system, which contains, among other things, a breakdown of COVID-19 cases by vaccination status (including whether a person is vaccinated or not and how many doses they received) and which vaccine people received. A separate scientific manuscript detailing the analysis is being published along with this article, and Meduza’s calculations are fully available to view on GitHub.

While Meduza’s editorial office is confident in its calculations and conclusions, we were, until recently, still not absolutely convinced of the credibility of the data our source provided, as we had been unable to confirm it independently. This confirmation finally came in the form of a separate study conducted by a group of scientists led by Anton Barchuk from the European University at Saint Petersburg, whose methodology differed substantially from ours. Meduza participated neither in the planning stage nor in the analysis stage of the St. Petersburg study — but it fully confirmed our conclusions.

According to our research and to the independent study conducted by scientists in St. Petersburg, Russia is manufacturing and giving people an ineffective vaccine — even as the country’s COVID-19 infection rate continues to surge. Read our analysis below.

How can we trust the data?

Judging by a number of indirect indicators, the quality of the data from Moscow that our source provided us with is beyond doubt. Analysis of the data is consistent with what is already known about Sputnik and with the general scientific consensus on the relative effectiveness of the vaccines across different age groups. Falsifying data to this degree of precision would require both a deep knowledge of epidemiology and possession of accurate statistics about vaccination rates in Moscow.

The world knows almost nothing about the results of Russia’s vaccination campaign

December 5, 2021, marked one year since the beginning of Russia’s COVID-19 vaccination campaign. Large-scale vaccinations around the world began at almost the same time: first in Great Britain, then in the US and Israel, and then in other countries. In Russia, Sputnik V became the first and most widely given vaccine, while the vaccine given to the largest number of people around the world so far has been Pfizer/BioNTech (at the end of December, a total of about 700 million people in the US and the EU had been vaccinated, while the company had planned on producing 2.5 million doses in 2021). In other words, the lengths of time various countries’ vaccination campaigns had been ongoing were about the same everywhere — but the amount of information available about different countries’ results differed greatly.

“Available information” here refers not only to technical matters, such as clinical research protocols or the vaccines’ effectiveness after being registered; it also refers to more important questions, such as:

• How effective is Sputnik V in various adult groups?
• How did its effectiveness change after the appearance of the Delta and Omicron variants, which didn’t exist when the vaccine’s clinical trials were conducted?
• What protection does the vaccine provide against severe infection, mild infection, asymptomatic infection, and death?
• How long does vaccine immunity last, and does a person’s age play a role?
• What were the results of the vaccine booster campaign that began in Russia in July 2021?

And finally:

• What happened to the people who received the EpiVacCorona vaccine, which was registered by Russia’s Health Ministry despite the fact that no data about its epidemiological effectiveness had been published, and which is often referred to as an “effective vaccine” to this day despite the fact that nothing is known about its ability to protect recipients?

All of these questions are possible — even relatively easy — to answer. For Western vaccines, the answers already exist thanks to retrospective studies, in which vaccination results are analyzed after vaccine registration, during the course of actual public vaccination campaigns. This entails conducting an analysis of the infection rate among both vaccinated and unvaccinated people in separate medical facilities — or even through an entire region or country. Infection rate information is then cross-checked against vaccination registries. The result is a clear understanding of the vaccine’s effectiveness under real-world conditions — without the randomization and blinding of clinical trials, and with the effects of possible immunity decline and new COVID-19 variants.

It was these kinds of retrospective studies, for example, that first helped scientists realize that vaccines protect not against infection (the endpoint of most clinical trials at the time of vaccine registration) but against death. It’s impossible to measure this parameter in volunteers because of how rarely it occurs: accurately determining the frequency of death in COVID-19 patients would require not tens of thousands of volunteers but hundreds of thousands.

Retrospective studies also allowed scientists to determine how vaccine effectiveness was affected by the spread of COVID-19 variants that didn’t exist when the vaccines were undergoing clinical trials (these studies from England and Scotland, as well as this review from Uptodate and the most recent data on the Omicron variant in South Africa, are just several examples).

Finally, a number of retrospective studies have shown that the effectiveness of COVID vaccines falls over time and that a booster shot is thus necessary to maintain reliable immune protection — especially for older people (more about this here). Dozens of studies confirming this have already been done by researchers in Israel, Great Britain, the U.S., Sweden, and other countries (read an overview of some of the first of these studies here). Even tiny Qatar, which didn’t produce its own vaccine, made a notable contribution to the world’s understanding of vaccine immunity and COVID-19.

As far as the Russian vaccines go, things are quite strange: not only are no results of any retrospective studies publicly available, but there also aren’t even the results of any clinical trials are publicly available — despite the fact that undergoing trials were a requirement for the vaccine to be registered. In the case of Sputnik V, of course, things are much better, but the situation is nonetheless odd: almost everything we know about the vaccine comes from studies conducted abroad. There are, however, a few important exceptions:

• First of all, thanks to scientists from the European University at St. Petersburg, First Moscow State Medical University, Tarusa Hospital, and several other medical centers, we know that the vaccination (including all vaccines, though 96% of the group examined had received Sputnik V) provides protection at least from hospitalization: fully vaccinated COVID-19 patients are hospitalized five times less often than unvaccinated ones (preprint here). This is an important finding for Sputnik V, as it confirms the claims made by the vaccine’s developers. It’s also important that this retrospective study was done after the Delta variant had spread in Russia. Unfortunately, the study is also limited to information about severely ill patients who underwent CT scans, which means it can’t provide information about the vaccines’ effectiveness in the general population, as that depends, among other things, on the vaccines’ ability to prevent infection. The study’s second major limitation is the absence of any data about recipients of the EpiVacCorona vaccine.
• Another study, which focused on the vaccine Sputnik Light, was conducted by the vaccine’s producers from the Gamaleya Center using data analogous to that used in other countries: information from case and vaccine registries. It only covers Moscow residents and was done when Delta was the dominant variant in the city. The study is largely analogous to the one we conducted ourselves, which is described below, with the exception that only includes recipients of the Sputnik Light vaccine, which was used in Russia almost exclusively for booster shots. As a result, the information about the vaccine’s effectiveness is less important for Russian citizens than for the Sputnik manufacturers’ export goals. As a tool for analyzing Sputnik V or EpiVacCorona, however, this study is useless.
• Several studies that focused on the blood serum of Sputnik V recipients can indirectly provide information about immunity duration and the vaccine’s ability to protect against new COVID-19 variants. However, as Meduza has repeatedly reported, antibody studies can only provide supplemental and indirect information about vaccine effectiveness: different people produce different levels of antibodies, immunity isn’t limited to antibodies alone, and the correlation between antibody levels and immune protection is not fully understood.
• Finally, multiple studies of Russian vaccines have been published abroad. The most well-known include one study that focused on the effectiveness of Sputnik Light in patients over 60 years old in Argentina and another recently-published study that focused on the effectiveness of Sputnik V in Hungary. Both studies were important contributions to scientists’ understanding of the vaccines, but also had their limits: because they were conducted when the Alpha variant was still dominant, their relevance to the Delta and Omicron variants, which are both better at evading people’s immune systems, is limited.

Because of the lack of available data on vaccination and infection rates, practically no studies of the vaccine have been conducted in Russia. When looking for an answer to the question of who needs to get a booster shot, Meduza was forced to rely on data from the U.S. and Israel. When investigating how well the Russian vaccines protect people against the Delta and Omicron variants, we turned once against to data from the American pharmaceutical company Pfizer, or to reports from the British NHS. Despite the fact that Sputnik isn’t produced by Pfizer/BioNTech, trying to draw conclusions from other countries’ experiences is an unavoidable decision when it’s the only source of relevant information.

The questions we addressed above can’t be answered with certainty, but it’s important to realize that that’s not because the kinds of studies done in other countries are impossible in Russia. They’re not.

Conducting retrospective studies of vaccine effectiveness is relatively simple and straightforward. In order to assess the degree to which a vaccine lowers the risk of a disease outcome, you need to know who from your test group was hospitalized or tested, when it happened, whether these people were vaccinated, and what the disease outcome or test result was. Aggregated data with this information is published in Israel, Switzerland, Great Britain, and other countries. If you had this data in for region in Russia, or even for several medical facilities, in its unaggregated form, you could determine the effectiveness of EpiVacCorona and Sputnik as well as the frequency of breakthrough infections and immunity duration. You could do all this using several standard methods found in every medical statistics textbook.

The data necessary for these calculations exists — it’s collected by Russia’s Health Ministry, Moscow’s public health department, and multiple other medical agencies. Unfortunately, not one of these entities has shared this information with the public, nor have they published the results of their own analyses (with the exception of the small Sputnik Light study mentioned above).

Our analysis of morbidity data from Moscow

Meduza has obtained from a source data from Moscow’s public health department that has previously not been made public. With important qualifications outlined below, these data have helped us answer several important questions about the Russian vaccines.

The data consist of a table showing COVID-19 cases organized by disease severity, age group, and vaccination status over the course of two months: June and July 2021. The data from July also break the cases down by type of vaccine, including Sputnik V, EpiVacCorona, and CoviVac (which was received by very few people, and, as a result, we don’t analyze it in this article). The table contains aggregated data in groups; in other words, it doesn’t name any people, institutions, or anything else that would allow patients to be identified. Unfortunately, it doesn’t include information about when each person was vaccinated, which would allow us to draw conclusions about waning immunity.

Despite the large amount of information, the essence of our analysis was simple. We compared the share of registered COVID-19 infections in Moscow among recipients of different vaccines in each age group. We also took into account the city’s overall population in each age group, as well as the share of recipients of each vaccine in these age groups.

You can read about our method in more detail below. Before we discuss our formulas and biases, it makes sense to describe the main conclusions of our analysis, which have direct practical significance.

What we can say for sure

1. The Moscow health department’s infection rate data confirms that Sputnik V is effective at protecting against COVID-19, especially against severe infection.
2. According to this data set, the EpiVacCorona vaccine is not effective at all. The number of EpiVacCorona recipients was significantly lower than the number of Sputnik V recipients, so the confidence intervals of our estimates of EpiVacCorona’s effectiveness are quite large. The vaccine’s average effectiveness, however, was negative for all age groups: -16% for people 18-50 and even lower for the older age group. We believe this is due to a fully understandable and expected behavioral change after vaccination: people started living a more active lifestyle because they believed they were protected by the vaccine, but they weren’t.

What else we learned from the data

1. Older people who received Sputnik get sick disproportionately more often than younger people. But this doesn’t mean the vaccine doesn’t work — that would contradict many other studies. The limitations in our data mean that we can’t separate biological factors from behavioral ones, and the apparent decrease in effectiveness among older people may be due to other factors besides waning immunity.
2. Whatever factors might be behind the higher infection rate among older people in this group, given the results of worldwide studies of vaccine immunity, this preliminary data suggests that booster shots are necessary and urgent for older people specifically.

Given the limitations outlined below, we cannot solve the following problems without additional data:

1. We cannot determine whether Sputnik V’s effectiveness in an environment where the Delta variant is dominant differs from the effectiveness measured in phase III of its clinical trials, when Delta didn’t exist yet. The research methods used are too different to compare the results with enough precision. Nonetheless, comparing a vaccine’s effectiveness against different variants of a virus is wholly possible — and could have been done if medical workers had been tasked with keeping track when Delta began spreading. To compare the Delta variant with Omicron, medical workers should be instructed to record which strain infected patients have starting right now, as Omicron is currently displacing Delta (but it’s unclear whether they will be).
2. We don’t know how long the immunity provided by vaccines last. This can only be determined using complete, non-aggregated data about infection rates, including information about how long ago each person was vaccinated. Once again, Moscow’s health department has this information, but we do not.

A separate study reached the same conclusion: EpiVacCorona doesn’t work

Simultaneously with and independent of our analysis, EpiVacCorona’s ineffectiveness was discovered by researchers from the St. Petersburg study mentioned above — in a new, recently published article.

Earlier in this article, we mentioned a study, conducted in the summer of 2021, in which a group from the European University at St. Petersburg led by Anton Barchuk established Sputnik’s effectiveness against hospitalization. The study’s methodology went as follows: the scientists analyzed the share of vaccinated and unvaccinated people among St. Petersburg residents who tested positive for coronavirus and were sent to one of two patient centers. At the centers, the patients underwent diagnostic imaging tests, the results of which were used to determine whether hospitalization was necessary. This decision marked the end of the study — the scientists determined that among vaccinated people, the risk of hospitalization after a positive test was about five times lower than among unvaccinated people. In other words, vaccine effectiveness was determined to be 81% (95% CI: 68-88).

It’s important to consider that in the previous study, the researchers weren’t able to compare the effectiveness of different vaccines — they only had data about whether patients had been vaccinated or not, not about which vaccines patients had received. At the same time, the vast majority (about 96%) of vaccinated people in St. Petersburg at that time had received Sputnik V, so it was reasonable to assume that the effectiveness level they found said more about Sputnik than about other vaccines.

In the new study, published on January 24 as a preprint, recipients of different vaccines were considered separately, which allowed the researchers to determine the effectiveness of EpiVacCorona specifically. The average value they found was negative: the maximum was -40%. For comparison, our analysis of data from Moscow found that EpiVacCorona’s effectiveness among people 18-50 was -16% (with a 95% confidence interval from -144% to +45%) and was even lower for the older age group.

Our study and the study conducted by Barchuk’s group used different methods, data from different cities, and were done at different times, but both studies came to the same conclusion: real-world infection rates confirm that Sputnik V effectively provides immune protection — and EpiVacCorona does not.

How did the methods differ?

The study conducted by Barchuk’s group and our analysis used differed methods: theirs was a case control study, while ours was a cohort study. In their study, each COVID-19 patient (a person with a positive PCR test who was sent to a patient distribution center during the study) was assigned a “partner” from the control group (a person who was not ill at the time). The control group was designed to be as similar as possible to the infected group in all parameters that could potentially affect the likelihood of infection: sex, age, usually the region where they lived, etc. Then, the proportions of vaccinated and unvaccinated in each group were compared, which allowed the researchers to determine the vaccines’ effectiveness. We also created groups for our study, but we included the entire population of Moscow, so our reference point was citywide infection rate information.

The two studies had many other differences as well. For example, we were only able to divide people with severe cases by which individual vaccines, while the researchers in St. Petersburg were able to do it for everyone who had a positive PCR test and was sent to receive a CT scan (not all of whom had severe infections).

Both we and the St. Petersburg researchers tried to take into account the significant number of people who had already had COVID among the unvaccinated, but we used different methods to do this, too. Barchu’s group asked the participants themselves about past PCR tests (it’s clear from the preprint that they were able to take at least some of the past infections into account). We relied on information from Moscow’s citywide seromonitoring program (which tests the Moscow hospital patients’ blood for the presence of COVID-19 antibodies).

It’s also important to note that both the St. Petersburg study and our study (and, by the way, a study of Sputnik Light conducted by the developers themselves) suggest Sputnik is less effective in older people — it’s over approximately 70% effective for people ages 18-30 and under approximately 50% for people over 60.

But no reliable conclusions can be drawn about why this happens based on these studies alone. The fact is that none of the three studies mentioned take into account the potential difference between the vaccinated and unvaccinated in the proportion of people who have chronic diseases in each age cohort. It’s also unclear exactly what role the large portion of unvaccinated people who have already had COVID and recovered might play. (In the large Hungarian study of Sputnik V, no drop in vaccine effectiveness with age was measured.)

Whatever the case, other countries’ experiences all make a strong case for vaccine booster shots for older people.

EpiVacCorona is still being given to patients

Exactly how many people have received the EpiVacCorona vaccine is unknown for the same reason its effectiveness was unknown: information about the number of people who have received each vaccine isn’t publicly available. Instead, the vaccine’s manufacturer occasionally publishes information about the number of vaccines that have “entered civilian circulation.” On January 25, for example, Vector reported that 6.5 million sets of vaccines had entered circulation (calculated by dividing the number of doses that have entered circulation by two).

Aside from statements from the manufacturer, the only information we have to go by is our analysis of the vaccinated registry. According to it, more than 130 thousand people had received EpiVacCorona by the beginning of August — more than 4% of all vaccine recipients. Then Moscow drastically curtailed the used of the vaccine — by late July, it had plummeted. Outside of the capital, though, people continue to receive EpiVacCorona — in late December, for example, new vaccine shipments were reportedly delivered to the Moscow suburbs. There are regions where a larger share of the population received EpiVacCorona — example, as of the beginning of August, for example, almost a fifth of vaccine recipients in Yakutia had gotten EpiVacCorona, according to data taken from the region’s register of vaccinated people. In Perm Krai and Novosibirsk Oblast, the proportion was 10 percent.

We don’t know how the data changed in the fall and winter. Even if EpiVacCorona isn’t currently being used at all, however, the public health authorities still should have conducted a study of the infection rate among vaccinated people — and ultimately suspended the drug’s registration.

Meanwhile, Vector Research Center has no plans to stop production of the vaccine. According to a Vector representative, despite the report that the Healthy Ministry has temporarily stopped purchasing the drug, an order is expected in February 2022.

What now?

Since the beginning of the pandemic, Meduza has published hundreds of articles about how people should only be vaccinated with medications whose effectiveness has been proven, such as Sputnik V. Sputnik, which was created at the Gamaleya Center by a group led by Denis Logunov is an effective and extremely timely adenovirus-based vaccine. The drug’s (not stellar) reputation both around the globe and within Russia, unfortunately, don’t reflect its quality — largely for reasons related to informational transparency. The authorities’ unwillingness to publish the most important statistics related to infection rates forces people to search for answers to simple questions about Sputnik in foreign studies from San Marino, Argentina, and Hungary.

All of these problems, however, pale in comparison to the situation surrounding EpiVacCorona — which Russia continues to use in 2022, despite the fact that its effectiveness is unproven.

In our opinion, this is what the people in charge of applying the EpiVacCorona can (and should) do:

• First of all, Russia’s Health Ministry and the Moscow health department should issue a constructive response to this petition created by civilian researchers — and release both past and current depersonalized data about infection rates among vaccinated people and other information necessary for monitoring vaccine effectiveness, just as other countries do. Without this information, it will be impossible to gain the public’s trust — and thus impossible to win the battle against COVID-19.
• Secondly, the Russian Health Ministry should cancel EpiVacCorona’s registration and publish the results of the trials that allowed it to be registered.
• Finally, the developers of EpiVacCorona — the Vector Research Center — should release the results of Phase III of the drug’s clinical trial, which has been ongoing since the beginning of 2021, and the results of which have not been made public.

Story by Alexander Ershov and Olga Matveeva with additional reporting by Dmitry Kuznets.

Meduza would like to thank volunteers from the V1V2 Project, as well as Max Popov for their help preparing this material.

Translation by Sam Breazeale