Zika Virus R&D: No Vaccine Before 3 To 5 Years, Sample Sharing Needs Incentives

International experts convened by the World Health Organization this week on the Zika virus said vaccine development is a priority for the future but the most pressing need is to get diagnostic and prevention tools. Over 60 groups are hard at work on experimental products, according to the WHO, while a system of incentives to share virus samples is being considered.

At a 9 March press briefing, Marie-Paule Kieny, WHO assistant director-general, Health Systems and Innovation, said the meeting took place from 7-9 March, and provided the first global platform for scientists working on Zika virology and immunology, as well as clinicians, product developers, regulators, funders and policy experts, “to take stock of the R&D (Research and Development) pipeline.”

There is growing evidence that the Zika virus is linked to neurological disorders, such as microcephaly, a condition in which babies are born with a very small head. It is also linked to a condition known as Guillain-Barré, in which a person’s immune system attacks their peripheral nerves (IPW, WHO, 8 March 2016).

Kieny underlined the speed of the Zika R&D response compared to Ebola, and in particular in the area of data sharing. The WHO released a document [pdf] mapping the current Zika product pipeline.

The document states that “due to the high visibility of the Zika outbreak, a number of in vitro diagnostic manufacturers have already expressed an interest….” However, the document notes, there are a number of barriers remaining to allow for swift availability and use of in vitro diagnostics. In particular, WHO is working on developing target product profiles in collaboration with multiple partners.

WHO landscape analysis shows 18 active programmes working on vaccine development, including 5 academic groups, and 15 commercial entities, the document says.

Vaccine development is still at an early stage, Kieny said and although a vaccine might come too late for the current epidemic, “the development of a vaccine remains an imperative.”

According to Kieny, Zika diagnostic development is at a more advanced stage, and some tests have already obtained authorisation in some countries. She underlined regulatory challenges around the use of experimental technologies in public health emergencies.

Major regulatory agencies, such as ANVISA in Brazil, the United States Food and Drug Administration and the European Medicines Agency have committed to prioritising the expedited evaluation of Zika products, she said.

Professor Jorge Kalil, director of the Butantan Institute, Sao Paulo, Brazil, also speaking at the press briefing, said knowledge is lacking on the Zika virus, for example how the immune system clears out the virus.

He said a vaccine could not be delivered before three to five years, adding that a vaccine normally takes 10 or 12 years to develop.

Data, Samples Sharing: Incentives Considered

On data sharing and specifically the sharing of samples, Kieny said a lot of discussion arose around the subjects during the meeting. In particular, it was on what would be the incentives for data sharing, she said, adding that recognition in research work would be one of them.

Also discussed was the issue of samples sharing, according to Kieny. For the Zika virus, unlike for influenza viruses with pandemic potential, which are covered by a system of benefit-sharing (Pandemic Influenza Preparedness –PIP– Framework), the framework for samples sharing is not clear for the time being.

However, the sharing of samples has to be considered in the context of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity, she said.

WHO is looking at the type of benefits which could be provided in compensation for the sharing of virus samples, she said. Those benefits could range from simple recognition, to the sharing of chemical products generated with the results, as well as privileged access to vaccines which would have been discovered through the samples.

Brazil has signed the Nagoya Protocol but has not ratified it yet.

On a question about the funding of research in Brazil, which is facing financial difficulties, Kalil said Brazilian President Dilma Rousseff said the national budget would be managed in a way that enough money goes to research. He said that for pre-human studies on Zika, US$ 5-10 million should be enough to cover research costs.

Next Steps

According to Kieny, WHO will plan interventions to help countries strengthen their health systems, and to be better prepared. The WHO will closely follow the ongoing research projects ongoing in particular in Brazil and in Colombia, she said.

In terms of product R&D, WHO is working with a number of stakeholders to facilitate the sharing of samples, she said, helping with the choice of virus strains that could be used for the development of a vaccine.

Kalil told Intellectual Property Watch that for the moment groups working on Zika diagnostic tools and potential vaccines are using data collected before the current outbreak occurring in Brazil. The Zika virus has been around since 1947. Zika originated in Africa, then spread to Asia, and came to Brazil through Polynesia, he said at the briefing.

 

Image Credits: Catherine Saez