J&J fast-track Ebola vaccine for early 2015 trials

pharmafile | September 4, 2014 | News story | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Africa, Ebola, Mapp, zmapp 

Johnson & Johnson has announced it is to fast-track the development of a new vaccine programme to fight the deadly haemorrhagic virus Ebola that is currently sweeping across Africa.

The firm says that it will collaborate with its partners in global health to provide relief and to address the current Ebola outbreak, which has now killed 1,900 people according to the World Health Organization (WHO), mainly in West Africa.

The experimental vaccine features a so-called prime-boost regimen in which one vector is used to prime and the other to boost the immune response.

Human trials are expected to take place in early 2015 after direct funding and services were provided from the National Institute of Allergy and Infectious Diseases (NIAID), as well as Cruvell and Bavarian Nordic (BN).

This follows hot on the heels of GlaxoSmithKline, which last week announced it was also fast-tracking its new vaccine for the virus.

“Our primary goal in this escalating Ebola epidemic is to assist governments on protecting health workers, families and populations who are at high risk of being infected with Ebola as soon as possible in an effort to stop the disease from spreading further,” says Dr Paul Stoffels, chief scientific officer at J&J.

Cruvell and BN are currently developing vaccines against filoviruses, including Ebola, and they have already developed a combination regimen that could be used against the Zaïre species of the Ebola virus.

“In light of the current emergency in West Africa and given the evident, huge unmet medical need, we are stepping up our efforts and accelerating the Ebola programme currently in pre-clinical development,” says Dr Johan Van Hoof, global head, Infectious Diseases and Vaccines at Janssen.

The Ebola virus, which could infect more than 20,000 people in West Africa before the outbreak is controlled, will cost at least $490 million to treat those affected, according to WHO.

Van Hoof says: “We recognise the urgency of the situation and the need to collaborate with multiple partners to develop treatment and preventive solution for Ebola.”

Experimental drugs

Some Ebola patients have already been given an experimental medicine called ZMapp, which is made by San Diego-based firm Mapp, but has until last month only been tested on animals.

But in August it was given to several US aid workers, one of whom has since made a full recovery. A Spanish priest working in West Africa was also given the drug after he was infected with the virus, but he later died in a Madrid hospital.

The first confirmed case of a Briton to contract the virus was also given Mapp’s experimental drug.

British Nurse William Pooley, a volunteer at The Shepherd’s Hospice in Sierra Leone, this week made a full recovery after being treated in a special isolation unit at the Royal Free Hospital in London. He has now been discharged from the unit.

“I was worried that I was going to die, I was worried about my family and I was scared,”  Pooley told reporters. “I was lucky in several ways; firstly in the standard of care I received, which is a world apart from what people are receiving in West Africa at the moment.”

It is not clear if ZMapp helped Pooley, but doctors say that the levels of the virus in his bloodstream did fall extensively after the treatment.

The US Department of Health and Human Services has said a new federal contract worth up to $42.3 million will help accelerate testing of this treatment.

The Department says that Mapp would manufacture a small amount of ZMapp for early stage safety studies and animal studies needed to prove its effectiveness and safety in people.

Tom Robinson

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