Ebola Vaccine Candidates Centre Of Attention; Clinical Trials, IP Negotiations Start

Today, the World Health Organization gave a press briefing to update journalists on what to expect in the near future on Ebola treatments and vaccines.

According to a WHO situation report [pdf] of 17 October, a total of 9,216 cases have been reported in seven affected countries (Guinea, Liberia, Nigeria, Senegal, Sierra Leone, Spain and the United States). Senegal and Nigeria have been declared free of the virus transmission by WHO in the last few days.

Somme 4,555 death have been reported, the report says. Guinea, Liberia and Sierra Leone continue to sustain a widespread epidemic.

Marie-Paule Kieny, WHO assistant director-general for Health Systems and Innovation, said at the press briefing that the international effort was based on three types of products: blood and serum of convalescent patients, drugs and vaccines.

Recent guidelines have been published on the use of blood and serum of convalescent patients, she said, as “great care is needed” to insure that the blood used is devoid of other infectious agents, and that the procedure guarantees the safety of donors and recipients.

Some partnerships have been put into place to safely extract plasma from blood so as to have a preparation that can be used, she said. There is hope that in the coming weeks, facilities will be set up to collect, treat and process blood for use in the three affected countries.

On drugs, a number of initiatives are being put into place, with a view to obtaining a global response, according to Kieny. The French government is expected to set up clinical trials in Guinea, she said, to conduct trials on a drug developed by a Japanese company. The first trials should take place “in the short weeks to come,” she said.

Some consultations are currently being carried out and organised by WHO, she explained, to discuss the ethics of different clinical trial designs, in particular the question of ethicality of using placebos in clinical trials.

On vaccines, a lot of activity is going on, in particular on two lead candidate vaccines. One is from GlaxoSmithKline and the other one developed by the public health agency of Canada, she said.

The GSK vaccine is expected to enter clinical trials in Lausanne, Switzerland by the first days of October, she said. The Canadian public health agency has licensed the vaccine to NewLink, a US company. The vaccine is expected to be tested in Geneva, Hamburg (Germany), Gabon, and Kenya, Kieny said. Clinical trials are expected to start in the coming two weeks, she said.

Those clinical trials are expected to help in measuring the optimal dose of vaccine necessary to be efficient, she said. This in turn will determine the number of vaccine doses that could be manufactured. A vaccine is also being worked on in Russia, she said, but added that she did not have further details on this particular candidate vaccine.

IP Discussions

According to Kieny, the vaccine developed by GSK belongs to the company, which “has a large experience in producing vaccines for developing countries.”

The WHO has started discussions with the GAVI Alliance about potential advance procurement mechanisms.

“We have also been reassured that the main development partners” which have been on the forefront of the response “would be willing to finance vaccines for distribution in West Africa,” she said.

The intellectual property on the other vaccine belongs to the government of Canada which has given a licence to NewLink. “We have the same discussion with NewLink,” she said.

Access to the vaccine at affordable prices is expected to be achieved through procurement, involving GAVI and other pooled financing mechanisms, she said.

[Update:]

According to a Gavi press release of 26 September, Gavi’s Executive Committee agreed that the Alliance “should review how it can mobilise to help tackle the unprecedented crisis.”

“The Executive Committee specifically requested that Gavi’s CEO work with Alliance partners to develop options for speeding up the availability of a potential vaccine, recognising Gavi’s expertise in shaping vaccine markets, track record in rapidly scaling up access to vaccines, and experience in innovative financing.”

According to the release, Gavi has invested over US$50 million to strengthen health systems for people in countries affected by Ebola. “If countries request it, Gavi will respond to their situation by looking at reprogramming current health and immunisation systems grants towards new health systems needs arising from the Ebola outbreak.”

Image Credits: US Army