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Hope Rises For Ebola Patients As WHO Approves Drugs by nerodenero: 7:29am On Aug 13, 2014
SUCCOUR is on the way for Nigerian patients of Ebola as the World Health Organisation (WHO) Headquarters in Geneva, Switzerland, yesterday approved that experimental drugs for the virus could be tested on them.

This came as the National Council on Health at an emergency meeting adopted a 14-point resolution on how to contain the Ebola Virus Disease (EVD) in the country.

The National Council on Health is the highest policy-making body in the country’s health sector and it comprises the Minister of Health as the Chairman, the Minister of State for Health, the Commissioners for Health in the states and the Secretary of Health and Human Services in the Federal Capital Territory, Abuja, as members.

The Permanent Secretary, Federal Ministry of Health is the Secretary of the Council.

A WHO panel of medical ethics experts ruled yesterday that it is ethical to offer unproven drugs or vaccines to people infected or at risk in West Africa’s deadly Ebola outbreak, but cautioned that supplies would be limited.

The panel said any provision of experimental Ebola medicines would require “informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community.”

The drugs should also be properly tested in the best possible clinical trials, it said.

Nigeria and Liberia had requested samples of an experimental drug, ZMapp that has shown some positive effects on two United States aid workers but failed to save a Spanish priest.

The Spanish priest Miguel Pajares, 75, the first European infected by a strain of Ebola died in hospital in Madrid, a spokeswoman for the city’s health authorities said yesterday.

The spokeswoman declined to say when Pajares, who was airlifted from Liberia on August 7 after contracting the disease while working for a non-governmental organisation in the African country, died.

The priest was being treated in the Carlos III hospital, where he had been in quarantine since his return from Africa.

The Health Ministry said he was being treated with the experimental drug ZMapp, manufactured by U.S. company Mapp Biopharmaceutical. Two U.S. aid workers infected by the disease have shown some signs of improvements since being given the drug.

Pajares was repatriated with co-worker Juliana Bohi, a nun who has tested negative for Ebola.

The National Council on Health received presentations on the status of the EVD outbreak and the preventive strategies and measures put in place to secure the Nigerian borders against further importation of the virus and subsequently adopted 14 resolutions.

Top on the resolutions is that state governments are to institutionalise communication strategy to ensure mass awareness creation and sensitisation for individuals and communities on EVD.

The council resolved that ideally all corpses should be accompanied with death certificates. All states are to be encouraged to have legislation to support this resolution. The corpses of all persons confirmed to have died of EVD must be buried according to standard WHO protocol.

It further directed that the transportation of corpses into Nigeria as well as interstate transportation be banned until further notice except with approved waivers that may be issued by the Federal Ministry of Health.

It urged the Nigerian Medical Association (NMA) to suspend its strike forthwith and contribute its quota to the ongoing response to this national health emergency.

According to the WHO, the West Africa Ebola virus epidemic – the world’s largest and most deadly so far – has killed at least 1,013 of the more than 1,848 people it has infected in Guinea, Liberia, Sierra Leone and Nigeria. The WHO has declared it an international health emergency.

The panel said: “Ebola outbreaks can be contained using available interventions like early detection and isolation, contact tracing and monitoring, and adherence to rigorous procedures of infection control. However, a specific treatment or vaccine would be a potent asset to counter the virus.”

The ethics panel met to discuss whether various experimental drugs and vaccines being developed for Ebola might be used in the outbreak, despite not having been fully tested or licensed.

WHO in a statement issued yesterday said: “A number of interventions have been through the laboratory and animal study phases of development.”

According to the statement, it is likely that the first tests of a drug in humans would be conducted over the next two to four months, but cautioned that even after that and if the trials proved successful, supplies would be limited.

“It is … likely that the number of doses available for further study and/or deployment from end 2014 onwards will remain insufficient to meet demand.”

The ethics meeting was called after experimental Ebola drug ZMapp, made by U.S. biotech company Mapp Biopharmaceutical, was given to two American health workers infected with Ebola in Liberia.

The scarce experimental drug, of which a WHO spokeswoman said only 12 doses had been made, was due to be given to two Liberian doctors after United States (U.S.) authorities approved its export, Monrovia’s information minister said yesterday. This would be the first time the treatment has been used on Africans.

The panel’s statement said: “In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.”

There are no licensed treatments or vaccines for Ebola. As well as Mapp, several other biotech companies and research teams have been working on potential drugs.

Companies with possible treatments include B.C.’s Tekmira Pharmaceuticals, Biocryst Pharmaceuticals and Siga Technologies.

GlaxoSmithKline and U.S. scientists at the National Institute of Allergy and Infectious Diseases hope to start a clinical trial of an experimental Ebola vaccine as soon as next month, after promising test results in primates.

It would normally take many years to move such a vaccine through three phases of clinical testing but some officials have suggested emergency procedures could be put in place to make it available in 2015, assuming it works in the early test phase.

Other experimental vaccines are also in preclinical testing.

The experimental drugs

According to Wikipedia, ZMapp is an experimental biopharmaceutical drug comprising three humanised monoclonal antibodies under development as a treatment for Ebola virus disease. The drug was first tested in humans during the 2014 West Africa Ebola virus outbreak.

To make ZMapp, the genes encoding for the antibodies were extracted from the hybridomas, genetically engineered to replace mouse components with human components, and transfected into tobacco plants.

The ZMapp drug is being developed by Mapp Biopharmaceutical Incorporation, a result of the collaboration between Mapp Biopharmaceutical (San Diego), LeafBio (the commercial arm of Mapp Biopharmaceutical), Defyrus Inc. (Toronto), the U.S. government and the Public Health Agency of Canada. The antibody work came out of research projects funded by the U.S. Army more than a decade ago and years of funding by the Public Health Agency of Canada.

ZMapp is composed of three humanised monoclonal antibodies that combine “the best components of MB-003 (Mapp) and ZMAb (Defyrus/PHAC).”

MB-003

A study published in September 2012, found that Ebola infected rhesus macaques survived when receiving MB-003 (mixture of 3 chimeric monoclonal antibodies), one hour after infection. When treated 24 or 48 hours after infection, four of six animals survived and had little to no viremia and few, if any, clinical symptoms.

ZMAb

A study published in November 2013, found that Ebola virus infected macaque monkeys survived after being given a therapy with a combination of 3 EBOV-GP-specific monoclonal antibodies (ZMAb), within 24 hours of infection. Two of four other monkeys that started therapy within 48 hours after infection also survived. The authors concluded that post-exposure treatment and a second lethal exposure after 10 and 13 weeks resulted in a robust immune response.

Production

ZMapp is produced transgenically and subsequently grown in large numbers in the tobacco plant Nicotiana in the bio-production process known as “pharming”. It was produced using ICON Genetics’ “rapid antibody manufacturing platform” in which tobacco plants are co-infected with viral vectors separately encoding light chain and heavy chain components of the desired antibody; the full antibody is assembled by the doubly-transfected cell. The antibodies are subsequently extracted and purified. The entire production cycle is believed to take a few months.

Use in humans

In the U.S., the Food and Drug Administration (FDA)’s Animal Efficacy Rule can be used, often in combination with a phase one clinical trial, to demonstrate reasonable safety for a drug, to obtain permission to treat urgently sick people with the drug under the FDA’s Expanded access programme. The Animal Efficacy Rule exists, because the normal path for testing the safety and efficacy of drugs is not possible for diseases caused by dangerous pathogens or toxins. The FDA has allowed two drugs, ZMapp and an RNA interference drug called “TKM-Ebola”, to be used in people infected with Ebola under these programmes.

Individual treatments

Samaritan’s Purse worked with the FDA and Mapp Biopharmaceutical to make the drug available to two of its employees under the expanded access programme. At the time, there were only a few doses of ZMapp in existence. According to news reports, Kent Brantly received the first dose of ZMapp nine days after falling ill. According to Samaritan’s Purse, Brantly received a blood transfusion from a 14-year-old boy who survived an Ebola virus infection before being treated with the ZMapp serum. His condition improved, and he was transported to the United States, where his condition continued to improve. An aid worker working alongside Brantly, Nancy Writebol, was also infected with Ebola virus at the same time. Her condition also improved before returning to the United States a couple of days later.

A Roman Catholic priest, 75-year-old Miguel Pajares, was flown back to Spain from Monrovia on August 7 after being infected with Ebola. With the permission of Spain’s drug safety agency, he was given ZMapp. He died on August 12, two days after receiving the drug.

Reaction

The lack of drugs and unavailability of experimental treatment in the most affected regions has spurred some controversy. On August 6, 2014, Peter Piot, who co-discovered the Ebola virus, and other scientists including the director of the Wellcome Trust, called for the release of ZMapp for affected African nations. The fact that the drug has been given to Americans and a European and not to Africans, has, according to the Los Angeles Times, “provoked outrage, feeding into African perceptions of Western insensitivity and arrogance, with a deep sense of mistrust and betrayal still lingering over the exploitation and abuses of the colonial era.”

However in light of the history of exploitation and abuses, Dr. Salim S. Abdool Karim, director of an AIDS research centre in South Africa said, responding to a question on how people may have reacted if ZMapp and other drugs would have been used first in Africans: “It would have been the front-page screaming headline: ‘Africans used as guinea pigs for American drug company’s medicine.’” Obama stated on August 6, “I think we have to let the science guide us”.

Other resolutions adopted by the National Council on Health include that particular attention should be paid to vulnerable groups such as market women and other women groups, patent medicine vendors, road transport workers, fishermen in the riverine areas, hunters and bush meat sellers, school children, morticians and mortuary attendants, traditional healers and faith-based groups.

The council observed that Emergency Operations Centres remain the responsibility of the Federal Government. However, the council urged states to establish communication channels as necessary that address general and peculiar needs in each State/Federal Capital Territory (FCT).

It directed the Federal Ministry of Health to provide state Ministries of Health and Health and Human Services Secretariat of the Federal Capital Territory Administration (HHSS FCTA) as well as military and para-military groups with support to strengthen training of health care workers at the State and Local Government Area (LGA) levels on proper infection control and EVD containment strategies.

The council directed Federal, State Ministries of Health as well as Health and Human Services Secretariat of the Federal Capital Territory Administration to provide adequate incentives to health workers who participate in the management of EVD patients to encourage them to be active in the containment of the EVD. It directed that they should be provided with life insurance coverage.

It directed that the Nigeria Centre for Disease Control (NCDC) should re-circulate protocols and Standard Operating Procedures (SOPs) for management of EVD cases as well as protocol for submitting samples to the laboratories and burying of EVD victims. The Federal Government should provide specifications and support states with special Personal Protective Equipment (PPE).

Meanwhile, Reuters yesterday quoted a Liberian official as saying that it would treat two infected doctors with the scarce experimental Ebola drug ZMapp, the first Africans to receive the treatment.

The death toll from the worst ever outbreak of the highly contagious disease has climbed to 1,013 since it was discovered in remote southeastern Guinea in March, according to the WHO.

It said ZMapp doses were very scarce, raising ethical questions of who should have priority.

SOURCE:The Guardian
Re: Hope Rises For Ebola Patients As WHO Approves Drugs by kayboy4y(m): 7:37am On Aug 13, 2014
Good News. Now I can shake hand with anybody abi?
Re: Hope Rises For Ebola Patients As WHO Approves Drugs by Nobody: 10:38am On Aug 13, 2014
It was on the news this morning sha, I pray they all pass the clinical trial stages and become available in the market. God will bless their efforts.

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