20 years under Putin: a timeline

In mid-October the Russian Federal Medical Biological Agency (FMBA) announced that by the end of 2021, it intends to register the first Russian-developed medicine against the coronavirus—MIR-19. Parallels between the registration of the first Russian anti-COVID-19 drug and the first registered vaccine, Sputnik V, suggest that Russian authorities have not learned their lesson from the vaccine’s troublesome rollout, and mistakes are to be repeated.

 

In a September 2021 interview with RT, Musa Khaitov, head of FMBA’s Institute of Immunology, claimed that he doesn't expect MIR-19 to have “serious side effects.” At the time, the drug was still undergoing the second phase of clinical trials. Photo: FMBA’s Facebook page.

 

MIR-19, according to its FMBA developers, is a medicine used for “treatment, including preventive, of the coronavirus infection via pulmonary or intranasal administration.” MIR-19 clinical trials (phase two in the clinical research of the drug development process), began in March, with the Russian press reporting on its significant promise. Yet, as soon as these reports appeared, some Russian researchers quesioned the enthusiasm, as it was too early to judge the promise of a drug that is still being developed. Phase two of MIR-19 trials was completed in July. As early as October 14, while patients for the third phase of experiments were still being recruited, MIR-19 developers submitted the documents for its formal registration with the Russian Ministry of Health. The developers shared with the press their confidence that the registration process will be completed no later than the end of December.

While the drug is yet to be registered in Russia, and there is much that we do not know about MIR-19, certain worrying parallels can be drawn with Sputnik V, the first Russian coronavirus vaccine. First, very much like Sputnik V, MIR-19 registration is being considered before the completion of the third phase of experiments. This is a crucial breach of scientific and medical protocols, as only in phase three is a new treatment (or drug) tried on tens of thousands of people. Even facing a deadly pandemic, Western researchers and medical regulating bodies insisted that all three phases of drug development had to be completed before emergency authorization could be invoked.

As we outlined in our recent report “The Rise and Fall of Sputnik V,” while, according to various reports, the Russian vaccine has proved to be effective and safe for use despite being registered after only two phases of experiments, the actions of Russian authorities significantly undermined the vaccine’s reputation at home and abroad. This practice, which is being repeated with MIR-19, of prematurely registering an experimental drug, is not only a serious safety concern, but also a blow to public trust. According to focus groups, one of the key reasons for the low vaccine uptake in Russia—and a crucial factor of high vaccine hesitancy or rejection—was people’s worries about Sputnik V’s swift registration.

Another clear parallel between Sputnik V and MIR-19 is their names—both refer to the space race of the Cold War era. Like with Sputnik, the first man-made satellite launched into space, reference to the legendary Mir space station is meant to prompt pleasant political associations among Russians, reminding them of the country’s past glories. But these associations risk triggering an unexpected response to MIR-19, like what happened with Sputnik V, as we outline in the report. The tempered response to Sputnik V was in part due to the—quite accurate—public perception that this was a product of an ongoing race between Western and Eastern competitors. The Russian government’s disregard for medical ethics and willingness to cut corners and forfeit safety procedures in order to “win” this race are evidently repeated in its need to again be the “first” when it comes to MIR-19. One of the drug’s developers was quoted in the Russian press saying the “drug can be considered the first drug in the world capable of specifically treating COVID-19.” According to the Levada Center, in public perception, nevertheless, the government’s actions and attitudes only raise suspicions about a drug being a factor in political games.

By repeating its transgressions and pushing for early registration of MIR-19, as it did with Sputnik V, the Russian government is creating a “new normal” that endangers ordinary citizens by exposing them to experimental treatments. Disregarding its previous blunders, Russia continues to breed public distrust.

 

* Vera Michlin-Shapir is an expert on Russian foreign and defence policies, as well as Russian politics and media. She worked at the Israeli National Security Council, Prime Minister’s Office, 2010–2016. 

 

The rise and fall of Sputnik V

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