Nov 19, 2021
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Will foreign vaccines be given the green light in Russia?

Weaknesses and trump cards of AstraZeneca

Kirill Dmitriev, the head of the Russian Direct Investment Fund (RDIF), said that so far only AstraZeneca had submitted an application for approval of a foreign drug. He specified that the pharmaceutical company became the first international partner of RDIF to research the combined use of vaccines.

In September, it became known that the R-Pharm company began production of the AstraZeneca vaccine for export, TASS reports. So far, the production volumes are small, only a few thousand doses. But at the same time, the general director of the company, Vasily Ignatiev, noted that there are no plans yet to produce a foreign vaccine for Russia.

The authors of the “Without a Prescription” Telegram channel believe that so far there is no point in registering the drug. Against the background of numerous reports of thrombosis cases after vaccination with AstraZeneca vaccine, the demand for it will be small.

“Potentially, RDIF has a trump card in its hands in the form of a booster vaccination. At the end of July, the Ministry of Health approved testing a combination of AstraZeneca and Sputnik Light. The immune response from the cocktail is stronger than from each vaccine separately, ”the authors write.

The leading expert of the MedLabExpert Association, Alexander Solovyov, is confident that the British-Swedish vaccine will be allowed in Russia only on parity terms, that is, only after the approval of the Sputnik V EMA. The process of registering a Russian drug in the European Union has been going on for more than six months, and so far, apart from the promises of the Russian side to complete it as soon as possible, there is no result.

“RDIF is better able to see from their bell tower how close to completion the process of recognizing Sputnik V in Europe is. They can demonstrate their readiness to register foreign vaccines a little earlier, ”Solovyov told MedPortal.

Let there be Pfizer?

On November 12, clinical trials of an experimental drug Paxlovid, developed by scientists from the American company Pfizer, began in Russia. The studies are being conducted on a small cohort of 90 people in total. The preliminary results of evaluating the effectiveness of the drug are unprecedented: 89%, and in the group of volunteers who took Paxlovid, the death rate from COVID-19 was zero. During trials in Russia, experts will check the preventive effect of the drug, so people who have had close contact with symptomatic patients are allowed to participate.

Conducting clinical trials, even with a successful result, does not guarantee further registration of the drug in the country, and expert opinions on whether Paxlovid will be approved in Russia are divided.

Nikolay Bespalov, development director of the analytical company RNC Pharma, believes that this is unlikely. According to him, the process of providing services for the organization of clinical trials is well organized in Russia, and the Paxlovid trials can be part of a global project to assess data in different populations. The issue of treatment and prevention of COVID-19 is too politicized, and so far there are no prerequisites for Pfizer drugs to open up access to the Russian market.

“We must also understand that in making a decision on the registration of a medicine or vaccine, the issue of ensuring uninterrupted supplies and availability is important. It is unlikely that Paxlovid will be cheap for the mass consumer, ”the expert said.

Andrei Isaev, head of the DNKOM Research Center for Molecular Genetic Research, shares a different opinion, who believes that Paxlovid has every chance of being approved in Russia. In the development of etiotropic drugs for the treatment of coronavirus, domestic science has not advanced far, and after two years of a pandemic, all drugs created in Russia have dubious effectiveness, or do not have it at all.

“Those people who make a decision on the registration of drugs also want to undergo treatment with pakslovid if something happens, and not take a snack with arbidol,” Isaev said.

At the same time, the expert is sure that the Pfizer vaccine is unlikely to appear in Russia, except in limited access and for some speculative purposes. Sputnik V has shown a fairly high efficiency, and no one is interested in creating competition for it.

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