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PostPosted: Wed Aug 13, 2014 5:35 pm 
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niman wrote:
Opting Against Ebola Drug for Ill African Doctor
By ANDREW POLLACKAUG. 12, 2014

The doctor who had been leading Sierra Leone’s battle against the Ebola outbreak was now fighting for his own life, and his international colleagues faced a fateful decision: whether to give him a drug that had never before been tested on people.

Would the drug, known as ZMapp, help the stricken doctor? Or would it perhaps harm or even kill one of the country’s most prominent physicians, a man considered a national hero, shattering the already fragile public trust in international efforts to contain the world’s worst Ebola outbreak?

The treatment team, from Doctors Without Borders and the World Health Organization, agonized through the night and ultimately decided not to try the drug. The doctor, Sheik Umar Khan, died a few days later, on July 29.

Times Topic: The Ebola Outbreak in West Africa
The doses of the drug that were not used were eventually sent to Liberia, where other doctors made the opposite decision — and two American aid workers became the first people in the world to receive ZMapp. Both of them survived and are now being treated at Emory University Hospital in Atlanta.

“It’s a little political; that’s what it looks like to me,” Alhajie Khan, Dr. Khan’s brother, said of the decision. “Why would you not give it to him? The guy who helped all of these people.”

The provision of ZMapp, which is in extremely limited supply, to foreign aid workers has raised broad ethical questions about the disparities in treatment between white outsiders and the Africans who form the overwhelming majority of victims in the epidemic.

Those concerns were heightened further after Spanish officials confirmed that they had obtained a supply of ZMapp for a third patient, a 75-year-old Spanish priest who died Tuesday after having been evacuated to Madrid from Liberia.

The previously untold story of Dr. Khan, recounted by two doctors involved in discussions about whether to use ZMapp, offered an unusual glimpse into the wrenching ethical dilemma of when and how experimental drugs should be used to combat the Ebola epidemic in West Africa. Had the treatment team decided differently in his case, the first person treated with the drug would have been African.

On Tuesday, the World Health Organization endorsed the use of untested drugs to combat the outbreak, which has already killed more than 1,000 people and continues to spread. But ZMapp and other potential treatments are in such short supply that another politically charged question remains: Who should get them?

Marie-Paule Kieny, assistant director general of the World Health Organization, said at a news conference in Geneva on Tuesday that several drugs and vaccines had shown some promise in animal testing and might conceivably be used.

But none are “available in unlimited supplies right now,” Dr. Kieny said. “I don’t think that there could be any fair distribution of something which is available in such a small quantity.”

On Tuesday, Liberia’s government announced that it would receive ZMapp after its president, Ellen Johnson Sirleaf, requested the drug from the United States. It said the drug would be used to treat two doctors who have Ebola.

That would be the first known use of the drug to treat Africans, but it also might be the last for a while. The manufacturer, Mapp Biopharmaceutical, said that it had complied with a request from a West African nation, but noted in a statement that the available supply of the drug was now exhausted.

In the case of Dr. Khan, who has been called “the arrowhead of the fight” against Ebola in his country, the doctors involved said there was no intention to save the drug for Americans. They said it was not known that the American aid workers were sick at the time of the decision not to treat Dr. Khan, around July 23. Instead, they said, doctors feared stoking the considerable suspicion of Western medical institutions in the country, which was already making it harder to contain the outbreak.

“What they really didn’t want to do was kill Dr. Khan with their attempt at therapy,” said Dr. Armand Sprecher, a public health specialist at Doctors Without Borders. “If word got out that M.S.F. killed Dr. Khan, that would have implications for outbreak control,” he added, using the initials for the French name of the relief group.

Dr. Sprecher, who is involved in the procurement and use of drugs for Doctors Without Borders but was not directly treating Dr. Khan, said another factor was that Dr. Khan’s virus levels were so high it was believed the drug would probably not work.

He said the treatment team never discussed the option of using the drug with Dr. Khan himself, deciding it would do so only if it decided to go ahead with the treatment.

“There are an awful lot of people who are very traumatized by the whole event,” Dr. Sprecher said in a telephone interview from Brussels on Tuesday.

At the time the decision was made, less was known about ZMapp, which may have helped the two American relief workers, Dr. Kent Brantly and Nancy Writebol, who were initially treated in Liberia and then evacuated.

Dr. Sprecher said the Spanish priest, the Rev. Miguel Pajares, had received the first of three recommended doses of ZMapp. He said the drug sent to Spain had originally been obtained by Doctors Without Borders and the World Health Organization for use in emergencies. It was kept at the University Hospital of Geneva, which had the authority to decide how the drug was used.

http://www.nytimes.com/2014/08/13/world ... =auto&_r=0

DAKAR, Senegal (AP) — Doctors treating a Sierra Leone physician with Ebola defended their decision not to give him an experimental drug, saying Wednesday they feared it was too risky.

Calling it "an impossible dilemma," Doctors Without Borders explained in detail their decision in response to a New York Times story on the case. It would have been the first time the experimental drug was tried in humans.

The explanation came the same day that another top doctor from Sierra Leone died of the disease, further fueling a debate about how to apportion a limited supply of untested drugs and vaccines and whether they are even effective.

Ebola has killed more than 1,000 people and sickened nearly 2,000 in the current West African outbreak that has also hit Guinea, Liberia and Nigeria. Many of the dead are health workers, who are often working with inadequate supplies and protection.

At the time the experimental treatment was being considered for Dr. Sheik Humarr Khan, his immune system was already starting to produce antibodies suggesting he might recover, Doctors Without Borders said in the statement. Khan was also due to be transferred to a European hospital that would be more capable of handling problems that might arise, it said.

The experimental drug, ZMapp, is designed to boost the immune system to help it fight the virus. Since Khan's body was already producing an immune response, the doctors may have feared that any boost would kick it into overdrive.

In the end, the treating physicians decided against using the drug. They never told Khan of its existence because they felt it would be unethical to tell him of a treatment they might not use. Shortly after their decision, however, Khan's condition worsened, the statement said, and the company providing the medical evacuation decided not to transfer him. He died a few days later, on July 29.

"Every day, doctors have to make choices, sometimes difficult, about treatment for their patients," said the Doctors Without Borders statement. "Trying an untested drug on patients is a very difficult decision, particularly in the light of the 'do no harm' principle."

ZMapp has since been used on two Americans and a Spaniard. The California-based company that makes the drug, Mapp Pharmaceuticals, has said that its supplies are now exhausted, and it will take months to produce even a modest amount.

The drug has never before been tested in humans, and it is not clear if it is effective or even harmful. The Americans are improving — although it is unclear what role ZMapp has played in that — but the Spaniard died Tuesday.

The last known doses of ZMapp arrived in Liberia on Wednesday, carried personally by Foreign Minister Augustine Ngafuan.

Dr. Moses Massaquoi, who helped the Liberian government acquire it, told reporters at the airport that there was enough to treat three people. Previously, the government had said it would only have enough to treat two sick doctors.

They would be the first Africans known to receive the treatment.

While many have called for more experimental drugs to be made available, noting that Ebola patients often have little to lose and so much to potentially gain, others have expressed caution.

"To use this drug without having any information on its human benefits or dangers runs the risk of mistakenly thinking it is either effective or not based upon anecdotal evidence, a difficulty that could prove disastrous for later in this outbreak or future ones," said Dr. Philip M. Rosoff, director of the Clinical Ethics Program at Duke University Hospital.

Even if the ZMapp supply is finished for the time being, the debate will continue. Canada has promised to donate 800 to 1,000 doses of its untested Ebola vaccine to the World Health Organization and already questions are being asked about who will get it and how scientists will determine if it works.

Likely candidates for the vaccine are health care workers in Africa who are among the most vulnerable because of their close contact with Ebola patients.

Massaquoi, from Liberia, said negotiations for access to the vaccine are taking place now. Guinea is also considering asking for it.

Unlike ZMapp, which is being given to only a handful of people and is unlikely to yield significant information about the drug's effectiveness, the vaccine could be tested in a small, but more rigorous field trial.

"It gives us an opportunity to test the vaccine in an outbreak situation in populations that are at risk," said David Heymann, who professor at London School of Hygiene and Tropical Medicine.

Meanwhile, Nigeria confirmed that another person has died from Ebola, bringing the toll in that country to three. The man was under quarantine because he had contact with Patrick Sawyer, a Liberian-American who flew into Nigeria with the disease and died of it last month.

___

Cheng reported from London. Associated Press writers Clarence Roy-Macaulay in Freetown, Sierra Leone, Jonathan Paye-Layleh and Wade Williams in Monrovia, Liberia, Boubacar Diallo in Conakry, Guinea, and Maram Mazen in Lagos, Nigeria, also contributed.

http://bigstory.ap.org/article/who-cons ... one-doctor

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PostPosted: Wed Aug 13, 2014 8:57 pm 
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Ebola Virus Disease, Sierra Leone: Press Release
---------------------------
Ebola outbreak update: As of today, 12 Aug 2014, we have a total of 184 patients who have survived Ebola Virus Disease and were subsequently discharged. The total number of new confirmed cases is 21: Kailahun 2, Kenema 15; Bombali 1; Port Loko 2 and Tonkolili 1.

The total number of cumulative number of deaths is 259 and cumulative number of confirmed cases is 703 with Kailahun 378, Kenema 250; Kono 1; Kambia 1; Bombali 7; Tonkolili 2; Port Loko 22; Pujehun 3; Bo 22; Moyamba 4; Bonthe 1; Western Area Urban [Freetown] 11; Western Area Rural 1. As of today, Koinadugu district is the only district that has not registered confirmed cases of EVD in Sierra Leone

The cumulative number of probable cases is 38 and probable deaths 34, while the total cumulative number of suspected cases is 39 and suspected deaths is 5.

The World Health Organization has approved the use of the unregistered intervention for EVD in the 3 Ebola affected Mano River Union Countries of Guinea, Liberia and Sierra Leone. Meanwhile, the Government of Sierra Leone through the Emergency Operations Center has written a formal letter to the Director General of the WHO to request the drugs and to ascertain the number of doses available to the country.

The Indian Mercantile Association has donated 500 bucket sets with attached taps and basins to the Ministry of Health and Sanitation as their contribution towards the fight against the Ebola Virus Disease, meanwhile World Vision Sierra Leone also donated 300 million Leones [nearly USD68 000] to the Ministry of Health and Sanitation on behalf of World Vision International as their contribution in the war against the Ebola Virus Disease. World Vision also informed the Ministry of Health and Sanitation that it is in the process of procuring protective gear to be supplied to frontline health workers in health facilities across the country.

Ebola Viral Disease Situation Report: Ministry of Health and Sanitation, Sierra Leone
For more information please contact: District Health Management Team at District level
National level - Directorate of Disease Prevention and Control
<dpcsurveillance@gmail.com>
Mobile:- +23276913000

--
Sidie Yahya Tunis
Director, Information Communication Technology (ICT)
Ministry of Health and Sanitation, Sierra Leone

http://www.promedmail.org/direct.php?id=2680534

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PostPosted: Wed Aug 13, 2014 10:02 pm 
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MONROVIA (Reuters) - A consignment of experimental Ebola drugs arrived by plane in Liberia on Wednesday to treat two doctors suffering from the virus, which has killed more than 1,000 people across four West African countries.
The drug, ZMapp, arrived in white boxes on a commercial flight, a Reuters witness said. It will be taken to the John F. Kennedy Memorial hospital in the capital and administered to doctors Zukunis Ireland and Abraham Borbor, government officials said.
(Reporting by Clair MacDougall; Writing by Matthew Mpoke Bigg; Editing by Daniel Flynn)

https://uk.news.yahoo.com/experimental- ... ml#1BtH3nr

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PostPosted: Thu Aug 14, 2014 7:25 am 
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niman wrote:
Liberia: President Obama Approves the Use of Experimental Drug on Two Liberian Doctors undergoing Treatment for Ebola

The White House and the United States Food and Drug Administration have approved the request for sample doses of experimental Serum to treat Liberian doctors who are currently infected with the deadly Ebola virus disease.

According an Executive Mansion release, the approval was in response to an August 8, 2014 communication sent to President Barrack Obama by President Ellen Johnson Sirleaf in which she requested the experimental Serum to be used on the affected Liberian doctors.

The experimental drugs are to be brought in the country by a representative of the U.S. Government later this week.

Meanwhile, the Executive Director of the World Health Organization, Dr. Margaret Chan, has authorized the dispatch of additional doses of the experimental Serum to Liberia to support the treatment of affected doctors. The experimental Serum from the WHO will be brought in by one of its experts later this week.

http://allafrica.com/stories/201408113458.html

[2] Sierra Leone: official
Date: Tue 12 Aug 2014
From: Emergency Operations Center (EOC), Ministry of Health and Sanitation, Sierra Leone
Via ProMED Submit Info tab on <www.promedmail.org> [edited]


Ebola Virus Disease, Sierra Leone: Press Release
---------------------------
Ebola outbreak update: As of today, 12 Aug 2014, we have a total of 184 patients who have survived Ebola Virus Disease and were subsequently discharged. The total number of new confirmed cases is 21: Kailahun 2, Kenema 15; Bombali 1; Port Loko 2 and Tonkolili 1.

The total number of cumulative number of deaths is 259 and cumulative number of confirmed cases is 703 with Kailahun 378, Kenema 250; Kono 1; Kambia 1; Bombali 7; Tonkolili 2; Port Loko 22; Pujehun 3; Bo 22; Moyamba 4; Bonthe 1; Western Area Urban [Freetown] 11; Western Area Rural 1. As of today, Koinadugu district is the only district that has not registered confirmed cases of EVD in Sierra Leone

The cumulative number of probable cases is 38 and probable deaths 34, while the total cumulative number of suspected cases is 39 and suspected deaths is 5.

The World Health Organization has approved the use of the unregistered intervention for EVD in the 3 Ebola affected Mano River Union Countries of Guinea, Liberia and Sierra Leone. Meanwhile, the Government of Sierra Leone through the Emergency Operations Center has written a formal letter to the Director General of the WHO to request the drugs and to ascertain the number of doses available to the country.

The Indian Mercantile Association has donated 500 bucket sets with attached taps and basins to the Ministry of Health and Sanitation as their contribution towards the fight against the Ebola Virus Disease, meanwhile World Vision Sierra Leone also donated 300 million Leones [nearly USD68 000] to the Ministry of Health and Sanitation on behalf of World Vision International as their contribution in the war against the Ebola Virus Disease. World Vision also informed the Ministry of Health and Sanitation that it is in the process of procuring protective gear to be supplied to frontline health workers in health facilities across the country.

Ebola Viral Disease Situation Report: Ministry of Health and Sanitation, Sierra Leone
For more information please contact: District Health Management Team at District level
National level - Directorate of Disease Prevention and Control
<dpcsurveillance@gmail.com>
Mobile:- +23276913000

--
Sidie Yahya Tunis
Director, Information Communication Technology (ICT)
Ministry of Health and Sanitation, Sierra Leone

http://www.promedmail.org/direct.php?id=2680534

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PostPosted: Thu Aug 14, 2014 9:12 am 
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ZMapp is not the only option

14.08.2014, 14:40 clock
The experimental Ebola means "ZMapp" is currently popular. But there are certainly other drugs that combat the deadly virus. Also testing of vaccines could start soon - even in Germany.

Marburg / Galveston
Suddenly all want "ZMapp". After a few patients from industrialized countries have received the experimental drug, now want to Liberia and Nigeria the preparation. The problem: From the drug, there were only a handful of doses, and which are already committed. And no one knows whether the agent has so far only been tested on animals, helping people at all - and what side effects it has. "I can only advise caution," warns Stephen Becker of the University of Marburg.

The hype surrounding the previously tested only in monkeys means surprised to virologists, especially considering the tiny beginning of inventories. "ZMapp" was - as almost all Ebola-agent - with the support of the Department of Defense developed. Especially after the attacks with anthrax in 2001, the United States wanted to protect itself against any conceivable form of bioterrorism.

Said means consists of three antibodies that bind to the Ebola proteins. They are intended to enable the immune system to eliminate infected cells. Produced the antibodies in genetically modified tobacco plants. However, the production takes months.

In West Africa, many people wonder frustrated, why do not they get the Ebola drug ZMapp. But experts warn of possible consequences - medical, but especially also ethical.
Ebola drug ZMapp: straw in the fight for survival
The hype around "ZMapp" is all the more surprising as there is a second preparation, the monkeys help similarly well. The safety of "TKM-Ebola" has even been tested on a few people, also the agent could be produced faster.
The immunologist Thomas Geisbert of the University of Texas in Galveston holds "TKM-Ebola" for the best treatment option. The agent produced by a Canadian company is one of the so-called siRNAs (small interfering RNAs). These will attach to the so-called messenger RNA, which relays information in the cell to build proteins. So the construction of proteins is prevented, it takes the Ebola virus.

A guided Geisbert of test showed that the means protecting against Ebola infected primates. A study designed to test the safety in humans, launched in January, but was stopped in July by the U.S. FDA. Now, the study may continue subject to conditions.
"Zmapp" and "TKM-Ebola" were the only drugs for which a complete protection after infection with the Ebola Zaire virus - circulating in West Africa pathogen - was demonstrated in primates, emphasizes Geisbert.

In addition to these medicines, to help sick people, the hopes of two preventive vaccines directed. They should ensure that patients develop antibodies against a pathogen protein and so train the immune system for defense against Ebola. Both vaccines were tested extensively on animals years ago.

That tests on humans so far failed to materialize, Becker leads back to the fact that pharmaceutical companies for these agents saw no profitable markets. Now the Ebola epidemic seems to intensify exploration.

Recently announced representatives of the U.S. Institutes of Health NIH to launch in September a study with a vaccine that uses a modified adenovirus as a platform. The study could be completed by July 2015, it said.

The other, developed in Canada vaccine uses a so-called VS virus (vesicular stomatitis virus) as a base. VSV-EBOV could be tested starting in autumn by the German Centre for Infection Research in humans if sufficient doses are available - and there are donors. "If the conditions are met, the trial could start in two months," says Becker.

The project will start with about 20 participants then first. This could include employees of "Doctors Without Borders" and other helpers count. Should convince first results, it could be extended to Africa. "The study should start as soon as possible," says Becker.
He receives support from Klaus Cichutek. The President of the Paul-Ehrlich-Institute calls "quite intensively for now timely to enter with vaccine candidates that have been shown in animal experiments a good efficacy in clinical trials".

http://www.handelsblatt.com/technologie ... 0-all.html

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PostPosted: Thu Aug 14, 2014 7:34 pm 
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WHO pushes back against Ebola-related flight bans
Filed Under: Ebola
Lisa Schnirring | Staff Writer | CIDRAP News | Aug 14, 2014

With some airlines suspending flights to West Africa's Ebola outbreak region, the World Health Organization (WHO) today restated its position that the risk of disease transmission during air travel remains low, as a few doses of an investigational drug reached Africa.

Korean Air Lines (KAL) announced today that it would suspend flights to Nairobi, Kenya, starting Aug 20 to prevent the spread of Ebola virus disease (EVD), according to a report today from Reuters. KAL operates three return flights from Nairobi each week. Kenya has not reported any Ebola cases and does not border the affected area, though the WHO has urged it to take extra precautions, given the volume of travel between it and the outbreak countries.

Earlier this month, British Airways said it was suspending service to Liberia and Sierra Leone because of the EVD outbreak. Emirates Airlines, based in Dubai, has also suspended flights to Guinea.

So far, only one travel-related illness has been detected, in an airline passenger from Liberia who was sick upon his arrival in Nigeria, an event that sparked a transmission chain in the capital, Lagos. However, some airlines are concerned about the safety of passengers and staff who might need to seek care in a medical facility in outbreak countries.

WHO repeats advice against flight suspensions
Isabelle Nuttall, MD, director of the WHO Global Capacity Alert and Response, said in a WHO statement today that unlike flu and tuberculosis, Ebola doesn't spread through the air. "It can only be transmitted by direct contact with the body fluids of a person who is sick with the disease."

The WHO added that on the small chance that someone on a plane is sick with Ebola, the likelihood of other passengers and crew having contact with their body fluids is even smaller. Typically, when a person is sick with Ebola, they are so unwell that they can't travel. Health experts also say people who are infected with Ebola can't shed the virus until they have symptoms.

Last week the WHO's emergency committee on Ebola said the outbreak developments in West Africa qualify as a public health emergency of international concern (PHEIC), and it recommended a set of measures to curb the spread of the disease. The panel urged no bans on international travel or trade and that countries make sure they have the capacity to identify and care for travelers from Ebola-affected areas who arrive at travel hubs or destinations with unexplained fevers or other symptoms.

On its Twitter account today, the WHO said international airlines in affected countries are putting systems in place to screen passengers for possible infections. Global health officials have said exit screening in outbreak countries is likely to be more effective for flagging illnesses than entry screening in destination countries, because nonstop flights from African countries aren't the most common route, and it's more difficult to track passengers when they take multi-leg flights.

The WHO also tweeted that it is disappointed when airlines stop flying to West Africa: "Hard to save lives if we and other health workers cannot get in." (??)

Treatment, vaccine developments
In treatment developments, the first three doses of the experimental drug Zmapp arrived in Liberia last night, with two of them earmarked for two of the country's doctors who are in an isolation center at a hospital in Monrovia, the capital, AllAfrica reported today.

A Liberian health official said the government negotiated with the company, with the approval of the US Food and Drug Administration (FDA), to explore how the drugs could be given to the patients in Liberia. He also said negations are underway with other firms developing experimental Ebola drugs, including the Canadian company Tekmira, which makes the only Ebola treatment that has entered clinical trials.

Meanwhile, the president of NewLink Genetics Corp., which is developing an experimental Ebola vaccine based on technology developed by Canadian government researchers , said at least two contract manufacturers have been found to produce "tens of thousands" of doses in the next month or two, according to Reuters.

Charles Link, MD, told Reuters that the company's subsidiary has received funding from the US Department of Defense to speed up clinical trials and manufacturing. Canada's government recently announced that it will donate 800 to 1,000 doses of the vaccine that it has on hand to the WHO for use in battling the outbreak.

In another move that could speed development of an experimental treatment, BioCryst Pharmaceuticals, based in Research Triangle Park, N.C., announced yesterday that it has received an additional $4.1 million from the National Institute of Allergy and Infectious Diseases (NIAID) to conduct a phase 1 clinical trial of an intramuscular treatment for Ebola and other viral hemorrhagic fever diseases.

The additional funding for the treatment, called BXC4430, will also cover studies in nonhuman primates to gauge effective dose ranges and schedules.

The NIAID made its initial grant to BioCryst , valued at up to $22 million over 5 years, in September 2013.

In other developments, the FDA today warned consumers about online companies that are selling products to prevent or treat Ebola. In a statement it said it has received consumer complaints about a variety of products.

Though Ebola vaccines and treatments are under development, in early stages with very limited supply, there are no approved products that have been tested for safety or effectiveness, the FDA noted. The agency added that by law, dietary supplements can't claim to prevent or cure disease.

The FDA also mentioned that the CDC doesn't view the outbreak as a significant threat to the US public and noted that during outbreaks, fraudulent products that purport to prevent or treat the disease often appear on the market.

Latest African developments
Guinea's government has declared a national health emergency to tamp down the spread of Ebola, BBC News reported today, based on information from Guinea's state radio. The action is meant to trigger tighter border controls, order the immediate isolation of people with suspected infections, and prevent the movement of dead bodies from one town to another.

When the WHO declared a PHEIC on Aug 8, it urged the outbreak countries to declare national emergencies. Sierra Leone, Liberia, Nigeria had already declared national emergencies.

Sierra Leone has lost its second top doctor to EVD, Dr Modupeh Cole, who died yesterday at a Doctors Without Borders treatment center in Kailahun, the New York Times reported.

The health ministry said he was exposed to the virus while working in a hospital in Freetown, the capital, according to the Times report.

Nigerian health officials also today reported another death of a health worker, a nurse who had helped care for the country's first EVD case, a man whose illness was detected in Lagos after he had flown in from Liberia, the Associated Press (AP) reported today.



See also:

Aug 14 Reuters story

Aug 14 WHO statement

WHO Twitter feed

Aug 14 AllAfrica story

Aug 13 Reuters story

Aug 14 FDA statement

Aug 14 BBC News story

Aug 13 Times story

Aug 14 AP story
http://www.cidrap.umn.edu/news-perspect ... light-bans

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PostPosted: Tue Aug 19, 2014 8:39 am 
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MICAT Liberia ‏@MicatLiberia 10m
Min. Brown: The 3 Medical Doctors who agreed to be treated with the experimental Z-Mapp Drug are now responding to treatment.#EbolaInLiberia

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