The first safe and effective vaccine against Ebola, which has killed more than 11,000 people since the first cases were reported in West Africa in December 2013, “is at hand”.
Thus reacted the World Health Organization (WHO) after the results of the clinical trial done in Guinea, one of the countries most affected by the sickness with vaccine VSZ- ZEBOV, developed by the Canadian Agency for Public Health and licensed by the US Merck and NewLink Genetics Corp.
This biological demonstrated effectiveness in preventing disease percent percent in the first ten days of application.
The Colombian Ana Maria Henao Restrepo, member of the Global Alliance for Vaccines and Immunization WHO and who coordinated the clinical trials in Guinea explained This work, whose results were published in the medical journal The Lancet, was made possible by a large international cooperation.
In an interview with El Tiempo, Henao Restrepo explains what consisted this work and now comes with the vaccine. “We succeeded in this case is really a milestone, because we shortened the maximum time of development,” he said from Geneva (Switzerland).
Do you have an estimate of how many other groups are in the race for a vaccine? How developed are?
There are more than a dozen vaccines are under development, and behind every candidate there is a group of researchers trying to design ways to assess the vaccine efficacy, for which cases are needed. Although it is unfortunate, the epidemic is the opportunity. We know that Liberia, Guinea and Sierra Leone, the three countries most affected West Africa, some groups also working on vaccines.
What group is it?
The Liberia is led by the government of that country and the National Institutes of Health in the United States, testing the vaccine GSK and Merck, which we also use in Guinea. Likewise, a group of Sierra Leone and the US CDC, which is evaluating it our vaccine, but health workers. There are also plans to evaluate a vaccine Johnson & amp; Johnson, which requires two doses; There is a very large coalition of researchers behind this project, which includes experts from the London School of Tropical Medicine. Finally, are we in Guinea.
How would you describe the Ebola virus?
is a condition that has been with us for some decades, but he never captured so much attention, because we had not had an epidemic of the magnitude of the latter, for so long and with so many affected. It is transmitted from person to person through body fluids, direct contact between people, manipulating clothing and personal items touched by a patient with symptoms. It is an evil that then affects the family and social groups.
How much estimate is mortality from this virus?
The death rate during epidemics changes slightly over time; generally it lies between 60 and 70 percent. It is very lethal. Guinea has been devastating, we have known cases where, for example, and on behalf of the transmission chains, all members of a family disappear from the disease.
How much had been working in this vaccine? What are its characteristics
It was designed by experts from the Public Health Agency of Canada; then he was transferred to the laboratory NewLink Genetics, US, and late last year Merck acquired the rights to the vaccine.
What is its structure?
was prepared from stomatitis virus cow which is benign to humans; what it did was change a very small part of it and put some kind of hat (in this case a protein) of Ebola, so to enter the body, the immune system can recognize and encourage him to develop defenses against this disease.
How to trials linked to this vaccine?
For more than two decades ago working with the World Health Organization Bless you; I am part of the Department of Vaccines and Immunization. When the epidemic began I was assigned to work in the research component of the Response Team to Ebola. When you start work in Guinea I was appointed as coordinator of the project.
Why, although this virus is known long ago, only now the world sees concrete results like this …
Unfortunately develop vaccines is not like in the movies, you need to work for decades. What has been achieved here is truly a milestone, because we shortened the maximum time of vaccine development.
Tell me a little about the process of this vaccine …
The researchers first animal studies to establish if they could develop antibodies (defenses) against the virus after they were exposed to the disease (challenge) to find out if they survived; in this case 100 percent of them succeeded. After studies were done in human phase one in the US, Europe and Africa; these trials, which began in October 2014, a group of people who will be followed to see if after vaccination adverse effects were joined. Preliminary results were published in January this year in the New England Journal of Medicine. Currently they are being Phase II studies in several countries, including Gabon (also had to Phase Two in Liberia and Sierra Leone) and in parallel we are doing the phase three in Guinea.
How many people participated in the trial of Guinea?
We focus on people at high risk of acquiring the disease, ie, whose communities or families cases were confirmed Ebola, in the week prior to our hometown. Vaccinate about 4,000 over 18 years.
What was the test?
We developed lists that included all contacts each confirmed case (relatives, people living in the same household), and contacts of those contacts; in other words, we map your social network. All we offered the vaccine, which received after signing an informed consent. Some were vaccinated immediately and another 21 days later. We found that in communities that immediately received the vaccine, more cases of the disease were not presented in the study period. In vaccinated in late, other cases were reported.
What’s next vaccine?
We will continue the clinical trial in Guinea, but immediately vaccinating all contacts social network of positive cases that arise. We will continue until the termination of the epidemic. In this way we will get concrete evidence to perhaps definitively conclude that the vaccine is safe and effective. At the same time, if we can, we will contribute stopping the epidemic in that country.
So is more evidence do you need?
Yes, we also need regulatory agencies in each country to review the results, the evidence and conclude independently whether it is sufficient or if more data is missing.
How many people participated in this vaccine in Guinea
It is a great team; 95 percent, I am proud to say that, they are Guineans. We have respected the ability of the country and have helped improve the way we do research. We’ve trained on good clinical practice. We have a group of between 250 and 300 people who support the team of Guinea and international experts. We have a committee of experts, another vaccine safety and coordination with a group of international experts. So I emphasize the value of the United Nations and WHO, and its ability to mobilize all with a common goal.
SONIA KNOB SANTAMARÍA
LIFE Deputy Editor
Write to sonper@eltiempo.com
Twitter: soniaperilla,SaludET
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