Vaccine under the veil of secrecy

Yana Khlyustova

A vaccine against Ebola has been created in Russia, Vladimir Putin said. About whether it is possible to create a vaccine in a year and a half, why information about the drug is intended exclusively for official use and how two strains of the virus can be defeated "with one blow", says the science department of the newspaper.Ru».

On the evening of January 13, at a meeting with the government, Russian President Vladimir Putin announced the registration of a highly effective drug against Ebola. "We have good news, I will ask the Minister of Health to tell about it. We have registered a drug for Ebola fever, which, after appropriate checks, shows high efficiency, higher than those drugs that are still used in the world," the president said. The submission of documents for the registration of the vaccine was reported at the end of December last year, and the head of Rospotrebnadzor Anna Popova at the same time said that the Russian vaccine will be vaccinated in a test mode by citizens traveling abroad, namely to the countries – foci of the disease.

After the announcement of the registration of a highly effective vaccine against Ebola, the science department of the Newspaper.Ru" contacted the Ministry of Health to find out details about the development of the drug, however, the press service of the ministry reported that "unfortunately, it will not be possible to respond promptly and quickly to the request."

Health Minister Veronika Skvortsova, however, reported that as many as two vaccines were registered. "The first vaccine is unique and has no analogues in the world, for the first time two viral vectors with different vaccine structure are included on the basis of the most modern biomedical technologies. As a result, it was possible to stimulate not only humoral, but also cellular immunity, and the virus was completely neutralized in all vaccinated, 100 percent neutralization, with a very low concentration of the vaccine. I have already said that there are no analogues in the world for this vaccine. I would like to emphasize that the available two drugs – the American vaccine from Merck and the European, British vaccine from GlaxoSmithKline – are inferior several times in effectiveness," the minister said. – And the second vaccine was specially made for cohorts of the population with immunodeficiency, which is of great importance for those countries where foci of infection occur. This vaccine is an analogue of the British vaccine, and the main mechanism is a significant activation of cellular immunity by more than 35 times. The vaccine is more effective than its British counterpart."

According to the Minister, both vaccines were produced at the Gamalei Research Institute of Epidemiology and Microbiology, tested at the preclinical stage in the institutions of the Ministry of Defense, and clinical studies were conducted jointly with the Ministry of Health and the Ministry of Defense. Nevertheless, there are no publications of Russian scientists in peer-reviewed international scientific journals on the development of an Ebola vaccine.

There are more than 400 scientific publications in the PubMed medical articles database at the request of the Gamaleya Institute of Epidemiology and Microbiology (N.F. Gamaleya Institute of Epidemiology and Microbiology), including two for 2016. But if you add the words "Ebola vaccine" to the query, the search does not give a single result.

It takes a very long time to create a vaccine – 10-15 years, but the active development of vaccines against Ebola began with an outbreak of the disease – in the fall of 2014, Russian Minister of Health Veronika Skvortsova said that within six months our country will present three vaccines against fever.

Obtaining a certain strain is only part of the work, such stages as testing and checking its safety take a long time. Nevertheless, detailed information about who, when and how exactly managed to bring the vaccine to readiness in such a short time remains unknown: at the time of active work on the creation of vaccines, it was not possible to obtain more detailed information about them. So, the deputy director General of the State Research Institute of Virology and Biotechnology "Vector" Alexander Agafonov declined to comment, referring to the ban of Rospotrebnadzor, and the request to Rospotrebnadzor remained unanswered.

Russian scientists have really been working with the Ebola virus for quite a long time – since the 1980s, when the virus was still considered as a biological weapon. According to experts, at that time the work was very successful, but the laboratory of particularly dangerous infections, where the research was conducted, was closed.

The former head of the laboratory of particularly dangerous infections of Vector, Alexander Chepurnov (the scientist began working with the virus in 1988), now working at the Institute of Clinical Immunology of the SB RAMS, at the end of 2014, said in an interview with Gazeta.Ru": "Unfortunately, no details. Therefore, it is very difficult to conclude whether it was really possible to assemble some kind of construction or whether the desired is given as valid. And in general, what is it: a recombinant vaccine or an inactivated one? What is the protection index for laboratory animals, primates? If its production is expected in six months, then everything should be known today.

After all, if they proceed to preclinical trials, the effectiveness of the drug should already be studied and these data should be published." However, there were no publications – information about the development of vaccines was limited only to brief reports from the Ministry of Health and Rospotrebnadzor.

According to Professor Mikhail Shchelkanov, head of the Laboratory of Virus Ecology at the D.I. Ivanovsky Research Institute of Virology, information about exactly how the vaccine was made and how it works is intended for official use. "Only specially authorized officials – representatives of the press services of the Ministry of Health and Rospotrebnadzor, for example, have the right to give answers to such questions. Veronika Igorevna, being not only the Minister of Health, but also a high-level expert, certainly said exactly what could and should be said. Thus, it seems to me, it is enough to quote it without comment," the professor told the newspaper.Ru». 

However, foreign developers of Ebola vaccines did not hesitate to talk in detail about their successes. As recently as today, January 13, a study by American molecular biologists (Frei et al., Bispecific Antibody Affords Complete Post-Exposure Protection of Mice from Both Ebola (Zaire) and Sudan Viruses) was published in the prestigious scientific journal Scientific Reports. Scientists have reported a successful trial of the first multi-purpose Ebola vaccine capable of neutralizing two of the most dangerous strains of this virus.

The Ebola virus exists in not one, but five variants. Two subspecies of the virus are considered the most dangerous among them – Zaire Ebola, the culprit of the 2014 epidemic, as well as Sudanese Ebola, which in the past caused major outbreaks of fever. Three other strains – Reston, Ty Forest and Bundibugio - did not cause large–scale epidemics and are found mainly among chimpanzees and bats.

All currently developed vaccines (at least those whose information is available to the scientific community) cope only with the first type of virus. The main problem is that the shell of each type of virus has a unique structure, and an antibody capable of coping with Zaire Ebola is simply unable to "break through" the protection of another type of virus.

A research team led by scientists Jonathan Lai and John Dai has created a new type of antibody by "assembling" it from two other antibodies designed to fight the Zaire and Sudanese types of virus. 

Researchers who have been working on creating a fever vaccine for several years have tested the antibody first on mice (their mortality has significantly decreased), and then on human cell cultures. Scientists plan to continue working and create a new version of the antibody that would cope with the third strain of the virus – Bundibugio, as well as the Marburg fever virus, which belongs to the filovirus family – like the Ebola virus.

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14.01.2015