“More Is Better” Says J&J As It Takes Up The Ebola Challenge
Executive Summary
Johnson & Johnson has leveraged its innovation model, reached out to partners, and fast-tracked a plan to produce one million units of an in-development combination vaccine for the lethal Ebola virus.
Responding to recent calls from WHO director-general Margaret Chan, MD, for more action in countering the spread of the lethal Ebola virus, Johnson & Johnson has leveraged its innovation model, reached out to partners and fast-tracked a plan to produce one million units of an in-development combination vaccine next year.
Speaking to reporters October 22, J&J chief scientific officer Paul Stoffels MD, said he had been authorized commit up to $200 million to accelerate J&J’s clinical testing program of the combination, which includes vaccines from Janssen Pharmaceutical Cos. and Danish company Bavarian Nordic AS. Pre-clinical tests in non-human primates gave 100% protection, he said.
J&J has paid an additional $43 million to acquire a 6.4% stake in Bavarian Nordic. [See Deal] J&J will take the lead in upscaling the combination vaccine – in which one vector is used to prime and the other to boost the immune response. The vaccines involved are based on AdVac technology from Crucell Holland BV, which is part of Janssen; and Bavarian Nordic’s MVA-BN. The regime was discovered in a collaborative research program with the US National Institutes of Health (NIH).
After safety, efficacy and immunogenicity have been shown, the company will work on Phase IIb and III trials. The first production goal is 250,000 vaccines ready for broad application in clinical trials by May 2015.
“We cannot predict when the epidemic will be over,” said Stoffels, who is also J&J’s worldwide chairman of pharmaceuticals. “But the WHO called last week for an acceleration of vaccine production as fast as we can.” The disease, 50% lethal, has already infected over 9,000 people and killed 4,500 in Liberia, Sierra Leone and Guinea. Elsewhere in West Africa, deaths have been reported in Nigeria, and infection in Senegal.
While the aim is to get the disease strain under control as fast as possible, this is unlikely to happen in the next 12 months, Stoffels said. But he added that the regulators are working with J&J “on a daily basis” in a bid to “get this done as fast as possible.”
One million is the target number of doses in 2015 – 250,000 per quarter. “We feel we can do that between us. We want to go significantly higher, but we cannot commit to that yet,” he said. For now, the requirement from the world community is “unlimited.” Test batches have been produced in the last couple of weeks.
J&J’s Ebola vaccine is not the only ongoing program – three are moving forward, including one from GlaxoSmithKline PLC. “More is better at the moment,” said Stoffels. “We will help each other if necessary, and we need to look at all options.” It may be that one vaccine takes precedence, but none have been proved yet. J&J is also seeking to secure additional partners and resources to assist in the production and clinical trial program.
As to who pays for the vaccine, there are mechanisms to solve this, he said. “The crisis is so big, and right, now we need to go fast.” What J&J is doing has similarities with what the company did when it discovered a new TB drug 10 years ago. “There was no economic case then, but it’s now been approved in South Africa,” said Stoffels, adding: “Economic value comes back indifferent forms.”
The group leveraged its well established innovation network in advancing the Ebola vaccine project to its current stage of development. “We’re organized in a biotech way – using internal and external sources.” (For more on J&J’s global network, comprising some 5,000 staff from which groups can be mobilized to support different projects, see (Also see "J&J’s Approach To Sourcing Innovation: Closing The Networking Gap" - In Vivo, 15 Oct, 2014.).)
As to precisely where the finished production batches are allocated, “that is not for us to say”, said Stoffels, believing that the authorities and major funders thus far (the US, France and the UK) should be in that decision-making group, along with the affected countries.