Human Trials to Test Ebola Vaccine Begin

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WASHINGTON, D.C. - The National Institute of Health (NIH) has received approval from the U.S. Food and Drug Administration (FDA) to begin human testing of a new Ebola vaccine. This will be welcome news for the millions of Americans who now face the very real possibility of encountering someone with the disease or contracting it themselves.

Currently, 357 people are being monitored in New York for possible exposure to the deadly virus, and Texas which was the epicenter for the first mortality from Ebola in the U.S. has been declared Ebola free.

According to the Los Angeles Times, "Nine people have been treated in the U.S. for Ebola, including Thomas Eric Duncan, a Liberian who died last month. One doctor, Craig Spencer, remains hospitalized in stable condition in New York."

The vaccine is undergoing a "human safety trial," which means it will be tested on "healthy human subjects to evaluate the immune response, identify any side effects and determine the appropriate dosage." (Source: NewLink Genetics)

The vaccine was developed by the pharmaceutical company Glaxosmithkline and the National Institute of Allergy and Infectious Diseases (NIAID), and is one of several being developed worldwide.

Earlier in the outbreak, the drug Zmapp was administered to seven aid workers. Five of the workers survived, though it's unclear how large a role the drug played in their survival. Due to the emergency status of the outbreak, treatments are not being monitored and tested as thoroughly as they would be if there was more time. Nevertheless, the U.S. Department of Health and Human Services has granted an $24.9 million 18-month contract with the manufacturer of Zmapp to expedite the development process.

VSV-EBOV is another experimental vaccine for the Ebola filovirus, developed by scientists at the Canadian National Microbiology Laboratory and is currently being tested in clinical trials in the U.S. at the Walter Reed Army Institute of Research in Silver Spring, Md. This vaccination purportedly does not induce any fever or other symptoms of illness. There is also evidence that this type of vaccine which can be administered orally or intranassaly as nose-drops may have potential as a treatment for those already infected. (Source: Wikipedia)

In Canada, permission has been granted for the vaccine VSV EBOV to be sent to Africa, but problems such as refrigeration during transport and storage have come up. Many of the villages that are most in need are in remote areas with bad roads, infrequent electricity, and and treatment is further hindered by the citizens mistrust of new technologies. It's clear that while developing a vaccine is an enormous step forward in the Ebola fight, there are still many political and practical obstacles to overcome.

Follow Sarah on Twitter Twitter: @nahmias_report Contributing Journalist: @SJJakubowski

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Malaria Vaccine | Bill & Melinda Gates Foundation

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Ayanna Nahmias, Editor-in-ChiefLast Modified: 22:08 p.m. EDT, 22 October 2011

I narrowly survived an infection of cerebral malaria when I was 10 years old.  We lived just outside of Dar es Salaam, the capital of Tanzania, and because my father did not believe in Western medicine, he forbade my mother from seeking treatment for me when I fell ill.  If treated at the immediate onset of symptoms the chances of recovery are quite high.

However, by the time she took me into Dar to the hospital, I beyond the threshold of medical intervention. The doctors told my mother to take me home and prepare for my death.  My mother did take me home where I lapsed into a coma while she tried everything she knew to break the fever and bring me back.

Through her valiant caring and prayer I awoke from my coma I remained critically ill for many months afterward.  I was one of the lucky few who survive cerebral malaria in which mortality rates for patients is as high as 50%.  This particularly pernicious disease  is the number one killer in the world today with a 90% percent of malaria-related deaths occurring in sub-Saharan Africa.

The PATH Malaria Vaccine Initiative (MVI) was funded in large part by the Bill & Melinda Gates Foundation and conducted trials on 6,000 children at 11 sites across sub-Saharan Africa.  The trials  showed that three doses of the RTS,S vaccine reduced the risk of children experiencing clinical malaria and severe malaria by 56 percent and 47 percent respectively.

Research is continuing, and efficacy and safety results in 6 to 12 week-old babies are expected by the end of 2012. Information about the longer-term protective effects of the vaccine, 30 months after the third dose, should be available by the end of 2014.

"A vaccine is the simplest, most cost-effective way to save lives," says Gates.

"These results demonstrate the power of working with partners to create a malaria vaccine that has the potential to protect millions of children from this devastating disease."

"These results confirm findings from previous Phase II studies and support ongoing efforts to advance the development of this malaria vaccine candidate," says Tsiri Agbenyega, a principal investigator of the trial and Chair of the Clinical Trials Partnership Committee.

"Having worked in malaria research for more than 25 years, I can attest to how difficult making progress against this disease has been. Sadly, many have resigned themselves to malaria being a fact of life in Africa. This need not be the case."

The team is now working towards approval by regulatory authorities. If the Phase III trials go well, the World Health Organization (WHO) has indicated that it could recommend the RTS,S malaria vaccine candidate as early as 2015, allowing African nations to include the vaccine in their national immunization programs.

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Twitter: @nahmias_report Editor: @ayannanahmias