Ebola Vaccine Team Welcomes New UK R&D Financing, Expects Governments To Join In

COPENHAGEN, Denmark — Having led the successful collaborative testing of an Ebola-vaccine in record time, John-Arne Røttingen of the Norwegian Institute of Public Health now wants to expand the idea to a permanent global financing facility for research and development. And he is optimistic.

“Something will happen by the summer of 2016,” Røttingen told Intellectual Property Watch.

Røttingen, who is executive director of Infection Control and Environmental Health, hopes the issue will be discussed by world leaders at Davos (World Economic Forum Annual Meeting) in January 2016. Talks are underway among different actors.

Røttingen says it is too early for specific countries to promise financial support to such a mechanism, but in November, the UK announced a new £1 billion fund to fight malaria and other infectious diseases.

“The UK government has through this budget announcement made the first move. This should be seen as a clear invitation to other governments and foundations to join forces on this important agenda,” said Røttingen.

In general, there is a need for high level political leadership to take this forward, Røttingen said. He admits he is optimistic, having worked on the issues of research and development (or lack thereof) into neglected diseases and other infections since the publication of the World Health Organization (WHO) Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) report in 2005.

Momentum: Oslo, Blueprint

However, Røttingen says there are specific developments at the moment.

One is a recent meeting held by the Drugs for Neglected Diseases initiative (DNDi) and the WHO in Geneva on 13-14 November. The meeting, in which representatives from Member States, industry and many NGOs participated, focused on antimicrobial resistance, and concluded with support to go ahead establishing a product development partnership for antibiotic development modelled after the DNDi success, according to Røttingen.

Another development is WHO’s work on developing a blueprint for R&D preparedness for epidemics. “The development of innovative funding options” is one of five work streams. The R&D blueprint will be presented for consideration at the World Health Assembly (WHA) next May.

As an input to this work, the NIPH and WHO held a consultation meeting in Oslo on 29-30 October. The outcome paper on “Financing of R&D Preparedness and Response to Epidemic Emergencies” [pdf] states that: “A new global mechanism would be instrumental in leveraging new and existing financing and structures for R&D preparedness and response.” It continues: “The mechanism with its financing facility could be hosted in an existing entity or a new one.”

Finally, Røttingen says research on diseases of poverty is also underway in the WHO Special Programme for Research and Training in Tropical Diseases (TDR). There are demonstration projects seed-funded by a new fund established at TDR by the WHO, and this feeds into the overall work towards a global R&D mechanism.

Beyond Patents – and the WHO

The need is clear. Countries need to collaborate on R&D and funding as patents do not constitute a sufficient incentive when it comes to vaccines and medicines for many infectious diseases, according to Røttingen.

“We need to establish a global financing facility for R&D,” Røttingen said, adding that such a voluntary mechanism would need “at least $1 billion” annually.

The WHO should have a central role in identifying where the need is greatest, but should not run such a facility, Røttingen said. The facility should be managed by an independent institution.

Røttingen says the idea can be likened to a global version of the US Biomedical Advanced Research and Development Authority (BARDA). It will, however, have a broader mandate driven by public health needs and health threats where the market model does not deliver.

The R&D facility would provide funding for innovation, and then the industry would be invited to be partners in projects. Røttingen emphasises that the industry with its production facilities and expertise is an important player.

“We need to have the industry on board,” he said.

Companies could keep their patents or share their rights, but contracts would come with conditions to secure access to products for populations at need through appropriate licensing arrangements or technology transfer mechanisms.

One version of this could be “equitable licensing,” Røttingen said. Companies could be “rewarded” after milestones such as the completion of Phase I and II. Røttingen was invited to the Danish Statens Serum Institut’s “Vaccine Day” to give a keynote about his consortium’s Ebola vaccine success story where WHO, Médecins Sans Frontières (MSF), Guinea and NIPH were main partners. Companies such as Novo Nordisk and Bavarian Nordic that were present expressed interest in the visions for a global R&D financing facility (Bavarian Nordic had an Ebola compound ready in 2011 but could not find funding). It was emphasised, however, that governments need to prioritise and collaborate across ministries.

Momentum: a Worldwide Risk

Another momentum for the R&D facility is the fact that diseases that previously belonged to the “neglected diseases” category now also affect Western countries. It is an issue of security and there is an incentive to act. One example is the Ebola-pandemic that peaked in 2014, but which recent resurgent cases in West-Africa show is far from over.

On 20 November, the WHO announced that a 10-year-old boy in Liberia had tested Ebola-positive. WHO also said it lacks US$123.4 million for its Ebola plan.

“Ebola shows that there is a risk facing the whole world,” Røttingen said.

A recent paper in The Lancet, however, criticises WHO for being too slow in declaring it an international public health emergency. More than 11,000 people died during the outbreak. The independent experts are from the Harvard Global Health Institute and the London School of Hygiene and Tropical Medicine.

The WHO is working on reform plans and a report will be presented to the UN Security Council by the end of this year.

Momentum: “My Story”

Røttingen’s own story of the successful Ebola vaccine developed through public-private partnerships is perhaps the best momentum in terms of advocating for a global R&D funding mechanism.

He agrees with some of the critique outlined in The Lancet, saying that the Guinea consortium could have started the testing of an Ebola vaccine six months earlier if WHO had called it an emergency already in March instead of August, and if Phase I trials had been carried out when the vaccines were ready to go into human trials. Thirty-year-old research on Ebola was ready to be tested in humans, but funds had been lacking. The national and international response was too slow, and the innovation system was not prepared, he said.

Røttingen says it took nine months from the first start of planning until the preliminary results of Phase III trials were published in the Lancet on 31 July 2015. The interim results indicated 100 percent effectiveness.

The Guinea vaccine working group was established at the margins of WHO’s high-level vaccine meeting on 23 October 2014. It held its first day-long meeting on 5 November at WHO. At that stage, the choice of vaccine was not made, but protocols were developed and a consortium was formed. Funding was raised in December and January. On 23 March, they started the study and from April until June it was implemented.

All in all it took nine months, leading people in the Copenhagen audience to whisper: “totally incredible.”

Others argue the study will go down into history as a clear example of “where there’s a will, there’s a way.”

Ring Study

The Ebola study was carried out by some 250 local staff including nine vaccine teams in Guinea. A ring-vaccination method was used, meaning that all contacts of a newly infected person (“index”) were vaccinated, often 50-100 people. These “rings” either received the vaccine immediately or three weeks later. The results were that in the first group there were no Ebola cases; in the second there were 16.

Some 10,000 people have received the vaccine so far. It has not been officially approved, but WHO says it operates with an “extended access protocol.”

The Ebola study was funded by: The Norwegian Ministry of Foreign Affairs (NMFA, through Globvac): NOK20.1 million ($2.3 million), MSF: NOK66 million, WHO: $2 million, Wellcome Trust: $7.2 million, and the International Development Research Centre (IDRC) in Canada: CA$2.6 million, according to the NMFA.

The vaccine was licensed to NewLink Genetics, and in November 2014, NewLink Genetics and Merck announced their collaboration on the vaccine, according to the WHO. The patent, however, still belongs to the Public Health Agency of Canada.

 

Image Credits: CDC, CDC