Tuesday, September 02, 2014

HHS Contracts With Mapp Bio To Develop Experimental Ebola Drug

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Although it is far from certain that the experimental monoclonal antibody cocktail called ZMapp is both safe, and effective against Ebola infection, early animal studies (see Nature: 100% Of Ebola Infected Macaques Recovered With ZMapp) have been highly encouraging, and we’ve seen anecdotal reports of improvement in some of the humans who have received the drug. 

 

Today the HHS has announced that BARDA (Biomedical Advanced Research and Development Authority) would provide funds, expertise, and technical support to help the manufacturer (Mapp Biopharmaceutical) to ramp up the production, and testing of the drug. 


On August 12 the manufacturer announced `The available supply of ZMapp™ has been exhausted’. At the time, reports indicated it could take several months to produce more. Hopefully this contract will help speed up that process.


This from the HHS Press Office.

 

FOR IMMEDIATE RELEASE
September 2, 2014

Contact: HHS Press Office
202-690-6343

HHS contracts with Mapp Biopharmaceutical to develop Ebola drug

Work will accelerate drug development and testing

The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). This contract supports the government-wide response to the Ebola outbreak in West Africa.

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide funding as well as access to subject matter expertise and technical support for manufacturing, regulatory, and nonclinical activities through a $24.9 million, 18-month contract with Mapp Biopharmaceutical Inc., of San Diego, California. ASPR can extend the contract up to a total of $42.3 million.

Work under the contract supports the development and manufacturing of the medication ZMapp toward the goal of U.S. Food and Drug Administration approval.

“While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy,” explained Dr. Nicole Lurie, assistant secretary for preparedness and response. “Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. government, and today’s agreement represents an important step forward.”

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CDC & WHO Press Briefings On Ebola

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Credit CDC PHIL

 

 

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Today the World Health Organization and the CDC both held press conferences (unfortunately, at the same time) on the Ebola outbreak in West Africa.   I was only able to listen in on the live CDC conference, and to the last part of the the UN conference, but both carried similar messages.


The Ebola outbreak in West Africa is moving faster than the response currently being mounted against it.  

 

A concerted international effort is needed now to defeat this epidemic, with the implied threat that we either deal with it now in Africa, or we risk having to deal with it for years to come around the globe.

 

CDC Director Dr. Thomas Frieden painted a grim picture in his CDC update on Ebola outbreak in West Africa saying that epidemic was `spiraling out of control’ , but stressed there was still `small window of opportunity’  to contain it.  

 

A transcript, and audio file, should be posted on the CDC Media website – hopefully later today.

 

CDC.gov, along with FluTrackers and others tweeted the event and you can follow the press conference using the twitter hashtag #DrFriedenCDC . A few examples follow:

 

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A word about the elephant in the room, which Dr. Frieden briefly discussed in today’s news conference; The possibility that the Ebola virus could – over time – mutate into an even more difficult to contain virus.

 

This is something we discussed at last week in Study: Ebola Virus Is Rapidly Evolving, and is always a concern whenever a zoonotic virus spills over into the human population.

 

Viruses mutate – that’s their basic mechanism of survival – but luckily over the past 40 years Ebola has tended to remain pretty stable, it doesn’t mutate as quickly as some viruses, like influneza or HIV.  


As Dr. Frieden said, the risks of seeing a dangerous mutation are probably low, but they aren’t zero.  The CDC, and other labs, will be watching for suspicious changes in the virus, but so far, there is nothing to suggest the virus has changed the way it spreads.


For brevity, individual statements by WHO Director-General Margaret Chan and the UN’s Special Coordinator on Ebola Dr. David Nabarro can be viewed on the following video links.

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The entire 77  minute briefing can be viewed at:

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The Lancet: Series On Emerging Respiratory Tract Infections

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Pneumonia Etiology Unknown – CDC PHIL

 

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This is mostly a head’s up, since I’ve not had time to read any of these papers. But as they appear to be both interesting and on point for this blog, so I decided to point my readers in their direction.

 

Among the authors you’ll find such familiar names as  Ziad Memish, Christian Drosten, Alimuddin Zumla, and Jaffar Al-Tawfiq.


This series is provided for free by The lancet, although (free) registration is required for full access.

 

Emerging respiratory tract infections

Published September 2, 2014

Executive summary

Emerging and re-emerging respiratory tract infections and the growing problem of antimicrobial resistance challenge diagnostic, treatment, prevention, and control strategies. Respiratory tract infections with epidemic and pandemic potential have plagued people since the dawn of human history. Comprehensive assessments of the global burden of disease show that respiratory tract infections are some of the commonest causes of morbidity and mortality worldwide, imposing a huge burden on health services. Several epidemics of new viral respiratory tract infections, most of which emerged from interactions between people and animals, have occurred in the past century.


The Lancet Infectious Diseases Series on emerging respiratory tract infections contains five state-of-the-art papers developed and written by international groups of experts with experience in management of emerging respiratory tract infections. The Series covers the topics of surveillance, pandemic potential, transmission and the environment, diagnosis, and treatment. The focus is on the emerging viral pathogens (particularly influenza, adenovirus, and coronaviruses) that pose the greatest threat, although bacterial, mycobacterial, and fungal pathogens are included where appropriate

Comment

Emerging respiratory tract infections

Zumla and others

Full Text | PDF

Series

Surveillance for emerging respiratory viruses

J A Al-Tawfiq and others

 

Full Text | PDF

Emerging infectious diseases and pandemic potential: status quo and reducing risk of global spread

B McCloskey and others

Full Text | PDF

Emerging viral respiratory tract infections—environmental risk factors and transmission

P Gautret and others

Full Text | PDF

Rapid point of care diagnostic tests for viral and bacterial respiratory tract infections—needs, advances, and future prospects

A Zumla and others

Full Text | PDF

 

Emerging novel and antimicrobial-resistant respiratory tract infections: new drug development and therapeutic options

A Zumla and others

Full Text | PDF

WHO: Virological Analysis Shows `No Link’ Between DRC and West African Ebola Outbreaks

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Actually this doesn’t come as a big surprise, but it does lay to rest an earlier report that suggested the DRC Ebola species was some sort of unusual  `hybrid’ between Ebola Zaire and Ebola Sudan. In fact, the outbreak in the Democratic Republic of Congo has now been identified as Ebola Zaire – and an older lineage at that – being most closely related to a strain that was seen in Kitwit, nearly 20 years ago.


Although the West African outbreak is also Ebola Zaire, it is of a different lineage, and therefore not connected to the DRC outbreak.


Ebola is endemic in the DRC (formerly The Republic of Zaire), and has caused at least 8 outbreaks in that region since the virus was first discovered in 1976.  The 1995 Kitwit outbreak infected 315, and killed 250 (81%). While the current outbreak is in a remote area, hindering its ability to spread, the WHO warns that this outbreak needs to be carefully monitored.

 

This report posted this morning from the World Health Organization.

 

Virological analysis: no link between Ebola outbreaks in west Africa and Democratic Republic of Congo

Situation assessment - 2 September 2014

Results from virus sequencing of samples from the Ebola outbreak in the Democratic Republic of Congo (DRC) were received last night. The virus is the Zaire strain, in a lineage most closely related to a virus from the 1995 Ebola outbreak in Kikwit, DRC.

The Zaire strain of the virus is indigenous in the country. Ebola first emerged in 1976 in almost simultaneous outbreaks in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan).

Confirmatory testing was done at Gabon’s Centre International de Recherches M├ędicales in Franceville, a WHO collaborating centre. Earlier, testing in DRC confirmed Ebola in 6 of 8 samples.

The outbreak is located in the remote Boende district, Equateur province in the north-western part of the country.

Results from virus characterization, together with findings from the epidemiological investigation, are definitive: the outbreak in DRC is a distinct and independent event, with no relationship to the outbreak in west Africa.

As the Gabon laboratory report clearly stated, “the virus in the Boende district is definitely not derived from the virus strain currently circulating in west Africa.”

These findings are reassuring, as they exclude the possibility that the virus has spread from West to Central Africa.

Epidemiological investigation has linked the index case, who died on 11 August, to the preparation of bushmeat for consumption.

This is the country’s seventh Ebola outbreak since 1976. The introduction of the virus into the human population following contact with infected bushmeat (usually fruit bats or monkeys) is consistent with the pattern seen at the start of previous outbreaks. The virus is now spreading from person to person.

The response team has, to date, identified 53 cases consistent with the case definition for Ebola virus disease, including 31 deaths. Seven of these deaths were among health care workers. More than 160 contacts are being traced.

The government has rapidly mounted a robust response by reactivating emergency committees at national, provincial, and local levels, setting up isolation centres, and providing community leaders with facts about the disease. The government will ensure that all burials are safe.

The WHO team confirmed that collaboration between the government and its key partners is excellent.

The outbreak zone, where the most intense transmission is occurring, is remote, located some 1200 kilometres from the capital city, Kinshasa. No paved roads run from the outbreak zone to Kinshasa. However, cases have been detected or transmission is ongoing at three sites, underscoring the need to watch the outbreak’s evolution closely.

Motorcycles, canoes, and satellite phones have been supplied to facilitate outbreak investigation and contact tracing. A dedicated helicopter will be made available soon.

FAO Alert: Ebola Outbreak Threatens Food Security In West Africa

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One of the scenarios we’ve looked at previously surrounding severe epidemics or pandemics involves disruptions in the supply and/or production chain, leading to shortages, price hikes, and severe economic downturns. All of which can lead to even greater misery and loss of life. 

 

We’ve discussed this cascade effect a number of times, including in the Supply Chain Of Fools, and in the CIDRAP Coal Report, which looked at crucial preparedness gaps in the United States that could lead to disruptions in the electrical grid during a severe pandemic.

 

The Ebola virus in West Africa has infected fewer than 10,000 people (official counts are 3,500 but are likely low) -  a small fraction of a single percent of the population – but the impact of the outbreak is literally being felt by millions.

 

Quarantines and checkpoints are limiting movement of people and goods, many residents are afraid to leave their homes, the affected countries are increasingly isolated from international travel and trade, and as a result many shops and other businesses are closed.

 

In many ways we are seeing on a small scale some of the types of social and economic impacts the world might face during a particularly severe pandemic. 

 

With crucial  harvests of rice, maize, millet & sorghum set to begin shortly, and the logistic nightmare imposed by the epidemic, the FAO today is warning that a major food crisis may lay ahead for the region:

 

Special Alert on Ebola in West Africa - FAO's Global Information and Early Warning System (GIEWS)

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Here is the news release from the FAO on this alert:

 

West Africa: Ebola outbreak puts harvests at risk, sends food prices shooting up

Agriculture in affected countries under significant strain, says new FAO special alert

Photo: ©Zoom Dosso/AFP

An empty street market in Monrovia's West Point district, 20 August 2014.

2 September 2014, Rome - Disruptions in food trade and marketing in the three West African countries most affected by Ebola have made food increasingly expensive and hard to come by, while labor shortages are putting the upcoming harvest season at serious risk, FAO warned today.


In Guinea, Liberia, and Sierra Leone, quarantine zones and restrictions on people's movement aimed at combating the spread of the virus, although necessary, have seriously curtailed the movement and marketing of food. This has lead to panic buying, food shortages and significant food price hikes on some commodities, especially in urban centers, according to a special alert issued today by FAO's Global Information and Early Warning System (GIEWS).


At the same time, the main harvest season for two key crops - rice and maize - is just weeks away. Labor shortages on farms due to movement restrictions and migration to other areas will seriously impact farm production, jeopardizing the food security of large numbers of people, the alert says.


Generally adequate rains during the 2014 cropping season had previously pointed to likely favorable harvests in the main Ebola-affected countries. But now food production - the areas most affected by the outbreak are among the most productive in Sierra Leone and Liberia - stands to be seriously scaled back.


Likewise, production of cash crops like palm oil, cocoa and rubber - on which the livelihoods and food purchasing power of many families depend - is expected to be seriously affected.


"Access to food has become a pressing concern for many people in the three affected countries and their neighbors," said Bukar Tijani, FAO Regional Representative for Africa. "With the main harvest now at risk and trade and movements of goods severely restricted, food insecurity is poised to intensify in the weeks and months to come. The situation will have long-lasting impacts on farmers' livelihoods and rural economies," he added.


Major spikes in food prices

Guinea, Liberia and Sierra Leone are all net cereal importers, with Liberia being the most reliant on external supplies. The closure of some border crossings and the isolation of border areas where the three countries intersect - as well as reduced trade from seaports, the main conduit for large-scale commercial imports - are resulting in tighter supplies and sharply increasing food prices.


In Monrovia, Liberia, a recently conducted rapid market assessment indicates that prices of some food items have increased rapidly - for example, in Monrovia's Redlight Market the price of cassava went up 150 percent within the first weeks of August.


"Even prior to the Ebola outbreak, households in some of the affected areas were spending up to 80 percent of their incomes on food," said Vincent Martin, Head of FAO's Dakar-based Resilience Hub, which is coordinating the agency's response. "Now these latest price spikes are effectively putting food completely out of their reach. This situation may have social repercussions that could lead to subsequent impact on the disease containment."


The depreciation of national currencies in Sierra Leone and Liberia in recent months is expected to exert further upward price pressure on imported food commodities.

Response efforts

To meet short-term food relief needs, the UN World Food Programme (WFP) has launched a regional emergency operation targeting some 65,000 tonnes of food to 1.3 million people.

At the same time, FAO's special alert says that "rapid assessments are required to identify the type of measures that are feasible to mitigate the impact of labour shortages during the harvesting period and for related post-harvest activities."
And measures to revive internal trade are essential to ease supply constraints and mitigate further food price increases, it notes.

Preventing further loss of human life and stopping the spread of the virus remain the top priorities at this time. FAO has joined the coordinated UN effort to support affected countries, is in daily communication with WHO and other key actors, and has personnel in West Africa aiding technical and logistical efforts.

It is critical that rural communities understand which practices pose the highest risks of human-to-human transmission as well as the potential spill-over from wildlife. Toward that end, FAO has activated its networks of local animal health clubs, community animal health workers, producer organizations, forestry contacts and agriculture extension and rural radio services to help UNICEF and WHO communicate risk to affected populations.

Japan: Locally Acquired Dengue Cases Rise To 34

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Credit Wikipedia

 

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Less than a week ago, in Japan Reports 1st Locally Acquired Dengue Case In 60 Years, we learned of a teenage girl  (without recent travel history outside the country), living in Saitama prefecture (near Tokyo) who had been diagnosed with Dengue fever.

 

This marks Japan’s first locally acquired case of the mosquito-borne virus since the 1940s (although a German tourist came home from a trip to Japan with Dengue in 2013).

 

In less than six days the number of Dengue cases reported from Japan has jumped to 34, with nearly all of them associated with recent visits to the  popular Tokyo destination Yoyogi Park (once part of the 1964 Olympic Village) , which is adjacent to the Harajuku railway station and Meiji Shrine in Shibuya.


Dengue fever cases jump to 34 as outbreak spreads around Japan

September 02, 2014

THE ASAHI SHIMBUN

Health ministry officials announced on Sept. 2 that 12 more cases of dengue fever have been confirmed from mosquitoes at Tokyo's Yoyogi Park, with the outbreak spreading farther across the country.

The latest patients reside in Tokyo, Osaka, Aomori and Yamanashi prefectures. Like the 22 other cases already confirmed, the 12 individuals have not gone abroad recently, but have visited Yoyogi Park in Shibuya Ward and its vicinity.

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While having a common, geographically-limited source may make eradicating their infected mosquitoes easier, the danger exists that visitors to the park either have, or will carry the virus to infect other mosquito populations in Japan. 

 

We’ll know that has happened if cases not associated with Yoyogi Park begin to emerge. 

 

While dengue infected mosquitoes may not survive Japan’s winter, the yearly influx of millions of tourists – many from regions of the world where Dengue is endemic – all but assures the virus will be re-introduced to Japan’s mosquito population in the future.

 

The World Health Organization estimates 100 million people are infected with Dengue each year, and 500,000 are sickened enough to require hospitalization.  The WHO considers Dengue to be the most rapidly spreading mosquito borne viral disease in the world, and that increasingly it is posing a threat to both Europe and North America. 

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Countries at risk for Dengue Transmission


For more on the spread of Dengue around the world you may wish to revisit these recent blogs:

 

PAHO/WHO: Epidemiological Alert On Chikungunya & Dengue In the Americas

Florida: Miami Reports 1st Locally Acquired Dengue Case Of 2014

Locally Acquired Dengue In New York City.