WHO Update On Zika R&D

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Please find below the introduction remarks by Dr Marie-Paule Kieny, Assistant Director- General, Health Systems and Innovation at WHO on Research and Development ( R&D) for Zika virus
 
Dr Kieny was speaking at a press conference in Geneva today 12 February 2016

The audio file of her press conference can be found:

Direct link: 

http://terrance.who.int/mediacentre/presser/WHO-RUSH_Zika_research_presser_KIENYm_UNOG_12FEB2016.mp3

 

Good morning:

As you know, our relatively poor knowledge of the Zika virus presents a series of challenges for R

 

After Ebola, WHO began to draw up a master plan for R

 

We have already identified a large number of manufacturers and research institutions either involved in the development of medical tools for Zika, or interested in embarking on such research.

 

Apart from what has already appeared in the press, numerous other groups are looking at the feasibility of initiating animal or human testing, particularly for vaccines and diagnostics. 

 

For vaccines:

•             The landscape is evolving very rapidly and numbers change daily.  About 15 companies/groups have been identified so far, most have only just started work.

•             Two vaccine candidates seem to be more advanced: a DNA vaccine from the US National Institutes for Health, and an inactivated product from Bharat Biotech, in India.

•             The current absence of standardized animal models and reagents is slowing down development.

 

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

 

For Diagnostics:

• 10 biotech companies have been identified so far that can provide nucleic acid or serological tests.  Nucleic acid tests are based on a molecular technique used to detect a virus in the blood; serological tests measure the levels of antibodies as a result of exposure to a particular virus
• 10 other companies are at various stages of development.
• It is important to point out, however, that none of these tests have been independently validated and none have 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. This will help prevent the distribution of poor quality or fake Zika tests that are sure to come up rapidly – as was the case with Ebola. 

 

Laboratory based Zika diagnostics (mostly non-commercial) are already playing an important role to better understand this outbreak, however, new validated and broadly available diagnostics are urgently needed to step up research, clinical management and surveillance. Although it is difficult to predict the time for the first commercial and independently validated tests to be available, we are talking weeks and not years.

 

WHO will continue working on landscape analyses for diagnostics and vaccines, as well as therapeutics, and innovative vector control measures.  These analyses will be published on our web site 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.

 

At the same time, WHO is developing what is called “target product profiles” for these medical tools – for example, what may be the best characteristics for a vaccine to immunize women of child-bearing age? 

 

In terms of diagnostics, we need to understand which type of product – nucleic acid, serologic, rapid test, etc. – will best serve our purposes.  We should have target product profiles ready in the next weeks.

 

In the area of therapeutics, studies are being carried out on medicines and other therapies that could prevent infection in vulnerable groups, especially pregnant women, as is done for malaria.   This seems for the moment a more viable and faster option than a curative treatment.

 

For vector control, innovative methods seem promising options – biological approaches for example, such as the controlled release of bacteria to prevent viral replication in mosquitoes; or genetic approaches, such as the release of genetically modified mosquitoes to reduce the mosquito population.

 

In terms of what happens afterwards, when potential products reach an advanced stage of testing and show promising data: we have in place the WHO Emergency Assessment and Listing procedure for the use of experimental products during an epidemic.  This accelerated assessment process was established during the Ebola epidemic and aims to ensure that products meet acceptable levels of quality, safety and efficacy – even if evaluation is fast-tracked - before they are rolled out in countries.

 

We will also provide support to countries wishing to register proven products to compress the time it takes to carry out ethical and regulatory reviews, so that these tools become available rapidly.

 

Thank you

 

 

Media contact

Daniela Bagozzi

[email protected]

Tel:+ 41 22 791 1990

Mob:+ 41 79 6037281

[email protected]

[niman]

Audio file

http://terrance.who.int/mediacentre/presser/WHO-RUSH_Zika_research_presser_KIENYm_UNOG_12FEB2016.mp3

[niman]

Zika virus

Zika virus: link with two disorders expected to be confirmed within weeks

Vaccines at least 18 months off, WHO says, as scientists work to determine if virus causes microcephaly and Guillain-Barré

 

 WHO’s assistant director general Marie-Paule Kieny at news briefing in Geneva on Friday. Photograph: Pierre Albouy/Reuters

Agencies in Geneva

Friday 12 February 2016 05.39 ESTLast modified on Friday 12 February 201606.34 EST

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The World Health Organisation expects the suspected link between the Zika virus and two neurological disorders, microcephaly in babies and Guillain-Barré syndrome in adults, to be established within weeks, a senior official has said.

Should we wipe mosquitoes off the face of the Earth?

 

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Marie-Paule Kieny, the WHO’s assistant director general, told a news briefing on Friday: “We have a few more weeks to be sure to demonstrate causality, but the link between Zika and Guillain-Barré is highly probable.”

She said it would take at least 18 months to start clinical trials of potential vaccines on humans, adding: “Two vaccine candidates seem to be more advanced: a DNA vaccine from the US National Institutes of Health; and an inactivated product from Bharat Biotech, in India.”

Kieny said 15 companies or groups have been identified as possible participants in the search for inoculations, but different types of possible vaccines – such as using live or deactivated virus, or DNA vaccines – may lead to differences in the timing on their development.

http://www.theguardian.com/world/2016/feb/12/zika-virus-link-microcephaly-guillain-barre-expected-weeks-vaccines