Real-World Testing of Ebola Vaccines

An effective vaccine would still not in itself be enough to stop the outbreak but could protect the medical workers who are central to the effort. More than 200 of them have died of Ebola.

The real-world testing in west Africa will go forward only if the vaccines prove safe and trigger an adequate immune-system response in volunteers during clinical trials that are either under way or planned in Europe, Africa and the US. The preliminary safety data is expected to become available by December.

One of the vaccines that Kieny mentioned, Okairos AG, is being developed by the US National Institutes of Health and GlaxoSmithKline from a modified chimpanzee-cold virus and an Ebola protein. It is being made in Rome, according to GSK, with clinical trials under way in Britain and Mali.

“We have other vaccine facilities around the world and we are seeing what we can do to ramp up production to commercial scale,” said Mary Anne Rhyne, GSK’s US director of external communications.

The second frontrunner, developed by the Public Health Agency of Canada and known as VSV-EBOV, has been sent to the US Walter Reed Army Institute of Research in Maryland for testing on healthy volunteers. It would also be tested shortly among volunteers in Switzerland, Germany, Gabon and Kenya, Kieny said.

Separately, the Canadian drugmaker Tekmira Pharmaceuticals announced on Tuesday it had begun limited manufacturing of a therapeutic product targeting the Ebola-Guinea virus.

Tekmira said on Tuesday that the new product, part of its TKM-Ebola programme, would be available by early December. But it did not specify how many doses it was making, or whether it was a drug or vaccine. Its TKM-Ebola programme is aimed at developing a treatment to stop the virus replicating in an infected person.

The European Medicines Agency said on Monday it was ready to offer Ebola treatments and vaccines the benefits of “orphan” drug status – including extended market exclusivity – in a bid to encourage their development.

Mapp Biopharmaceutical – which gave its experimental Ebola treatment ZMapp to US medical workers Dr Kent Brantly and Nancy Writebol, who recovered after contracting Ebola in Liberia, and to at least one Spanish priest, who died – said it had begun manufacturing the drug using conventional methods that would produce greater quantities for more human testing.

The outbreak in west Africa has killed more than 4,500 people, mostly in Liberia, Guinea and Sierra Leone, since it began 10 months ago. Experts have said the world could see 10,000 new cases a week in two months if authorities did not take stronger steps. (AP and Reuters information)