WHO Full Speed On Zika R&D, Two Candidate Vaccines Emerging; Funders, Journals Commit To Sharing Of Data

In an update on research and development against the Zika virus, the World Health Organization today said several companies are working on diagnostic tools, and two candidate vaccines are being considered. Discussions are ongoing with countries to encourage sharing of samples of the virus with the WHO, and leading organisations and scientific journals signed a declaration yesterday on the sharing of data for public health emergencies.

WHO is underlining a rapid research and development response to the spreading Zika virus, but insists that formal links to small-head syndrome and neurological effects caused by the virus have not been established.

The Zika virus, which had generally been known to cause minor health effects, such as mild fever, skin rashes and muscle and joint pain, now has the WHO’s full attention as it is suspected that the virus may cause babies of infected pregnant women to be born with a very small head (microcephaly), and an auto-immune neurological condition (Guillain-Barré syndrome).

The WHO R&D response to the Zika virus is proceeding very quickly, Marie-Paule Kieny, WHO assistant director-general for health systems and innovation, told a press briefing today. The WHO came under attack for its response to the Ebola epidemic and it seems it won’t get caught on future epidemics.

After Ebola, the WHO began to draw a master plan for R&D both to be prepared for health emergencies and to be able to have a fast R&D response in case of needs, Kieny said. The R&D Blueprint aims at accelerating the availability of medical countermeasures during epidemics (IPW, WHO, 8 February 2016).

“We have now established critical paths for coordinated action and industry interest in providing platform technology for the development of medical products,” she said. A “large number” of manufacturers and research institutions have been identified by the WHO, either already involved in development of medical tools for Zika or interested in embarking on such research, she said.

[Note: the WHO audiofile of Kieny’s press briefing is available here.]

Two Vaccine Candidates, Months Away from Trials

According to Kieny, for vaccines, the landscape is evolving very rapidly. Some 15 companies or groups have been identified by the WHO. Two vaccine candidates seem more advanced, one is a DNA vaccine from the United States National Institutes for Health, and the second is an inactivated product from Bharat Biotech, an Indian vaccine manufacturer.

In spite of this encouraging landscape, she warned that vaccines are at least 18 months away from large-scale trials.

On diagnostics, WHO has identified 10 biotechnology companies that can provide nucleic acid or serologic tests, Kieny said. Nucleic acid tests are based on the molecular technique used to detect a virus in the blood, she explained, while serological tests measure the level of antibodies as a response to exposure to a virus.

Some 10 other tests from other companies are at various stages of development, she added, but none of these have been independently validated and none so far has regulatory approval.

“The biggest task in the area of diagnostics will probably be to ensure an adequate reference method is used by manufacturers when generating their data, so that the performance of the various Zika diagnostics can be tested through an independent assessment,” she said, adding that this is expected to prevent the distribution of poor quality of fake Zika tests “that are sure to come up rapidly, as was the case with Ebola,” she said.

Although it is difficult to predict the time for the first commercial and independently validated tests to be available, the timing is likely in weeks and not years, she said.

WHO will continue working on landscape analyses for diagnostics and vaccines, as well as therapeutics, and innovative vector control measures, she said. These analyses are expected to be published on the WHO website in the next two weeks.

“Immediately after, we will convene independent experts to gauge which of these products seem the most promising as they move to the testing phase,” she said.

Access and Affordability: WHO Counts on Funders

On a question asked by Intellectual Property Watch about the access and affordability of eventual Zika vaccines and diagnosis tools (as most of the patients are in developing countries), Kieny said the WHO is working with a number of partners, for example on the Zika diagnostic tests target product profile and the cost of these tests is part of the target profile.

For vaccines it is too early to know if for example the “GAVI Board might decide to kick in as they did for Ebola,” she said. “But we hope, since that it is a vaccine which is very much needed, especially in developing countries, that we will have people come in putting money on the table.”

Sharing of Data and Samples

The need to share data is highlighted in the WHO R&D blueprint for R&D preparedness, she said. After the consultation that took place in September, editors of scientific journals made a statement that pre-publication of data that are important for a response to a public health emergency should become the rule, she said.

This seemed to have a snowball effect, she said, as there was a statement published yesterday signed by major funders of research, journals, and institutions pushing for data-sharing.

According to a Wellcome Trust press release, organisations including the Bill and Melinda Gates Foundation, Médecins Sans Frontières, the US National Institutes of Health, and the Wellcome Trust, as well as leading academic journals including Nature and the New England Journal of Medicine, signed a joint declaration on “sharing data and results relevant to the current Zika crisis and future public health emergencies as rapidly and openly as possible.”

Kieny said there has been a lot of progress. For instance, the WHO Bulletin now accepts publication on Zika immediately online, while they are being peer-reviewed, she said.

On the sharing of samples, she said samples are being shared, but there is still progress to be made in this area. The WHO is working with countries to see what terms on the sharing of samples can make them more reassured that they will maintain some ownership over the samples.

 

Image Credits: Flickr – Dean Calma IAEA, Catherine Saez