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Rossiyskaya Gazeta: Russia to launch large-scale international trials of COVID-19 vaccine

Russia will test its COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology on 40,000 volunteers, Kirill Dmitriev, who heads the Russian Direct Investment Fund, announced on Thursday. Besides Russia, international clinical trials will be held in Saudi Arabia, the Philippines, the UAE, and possibly Brazil and India. Russia is set to launch the trials next week, with doctors and teachers getting vaccinated at the same time.

Israel is also considering joining the clinical trials of the Russian vaccine, with the Hadassah University Hospital, namely its Moscow branch in Skolkovo, possibly forming part of the research.

Medical Director of Hadassah Skolkovo Polina Stepenskaya explained to Rossiyskaya Gazeta why Israeli specialists, who are working on a COVID-19 vaccine themselves, are ready to cooperate with their Russian colleagues.

“The development of a vaccine in Israel is still at the lab stage. It is unclear when clinical trials might begin,” Stepenskaya stated. “I hope that our clinic will have the opportunity to take part in this work. However, I would like to say that international cooperation, along with the joint work of researchers and medics from various states is what can speed up the search for a vaccine and drugs that can combat the new infection. So we are open to any joint endeavor, both in Israel and in Russia. Our Hadassah branch in Skolkovo is very interested in this project.”

“We could vaccinate about 15,000-20,000 people located in any hotbed of infection, if there is an outbreak in the area at the time, and then analyze whether they get infected naturally. This is the perfect option. As far as I am aware, Russia plans to do something similar now, offering to vaccinate doctors and teachers who agree to it. The goal is clear: both have a high chance of coming into contact with patients and children infected with the coronavirus. Those who wish to receive a vaccine will get it, and then experts will analyze the share of those who got infected anyway among those who received the vaccine and those who did not,” Stepenskaya explained.

Notes:

How Adenoviral vector-based vaccines work

Adenovirus vectors (Ad) generate significant host cellular immune responses and require strategies to remove or prevent expression of adenovirus genes, or possibly to develop approaches to transient immune modulation.

“Vectors” are vehicles, which can induce a genetic material from another virus into a cell. The gene from adenovirus, which causes the infection, is removed while a gene with the code of a protein from another virus spike is inserted. This inserted element is safe for the body but still helps the immune system to react and produce antibodies, which protect us from the infection.

The technological platform of adenovirus-based vectors makes it easier and faster to create new vaccines through modifying the initial carrier vector with genetic material from new emerging viruses that helps to create new vaccines in relatively short time. Such vaccines provoke a strong response from a human immune system.

Human adenoviruses are considered as some of the easiest to engineer in this way and therefore they have become very popular as vectors.

Safety and efficacy

After the start of the COVID-19 pandemic Russian researchers extracted a fragment of genetic material from novel coronavirus SARS-COV-2, which codes information about the structure of the spike S-protein, which forms the virus’ “crown” and is responsible for connection with human cells. They inserted it into a familiar adenovirus vector for delivery into a human cell creating the world’s first COVID-19 vaccine.

In order to ensure lasting immunity Russian scientists came up with a breakthrough idea to use two different types of adenovirus vectors (rAd26 and rAd5) for the first and second vaccination, boosting the effect of the vaccine.

The use of human adenoviruses as vectors is safe because these viruses, which cause the common cold, are not novel and have been around for thousands of years.

Header: Production of ‘Medgamal’ two components COVID-19 vaccine, developed by the Gamaleya National Research Centre for Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) at the Gamaleya National Research Centre in Moscow, Russia, August 6, 2020.

Source: Rossiyskaya Gazeta via TASS and SPUTNIK V