The World Health Organization has warned that the Zika R&D frenzy may not culminate in a vaccine in time for the current outbreak, but Sanofi Chief Scientific Officer Gary Nabel won't take that for an answer. Nabel says it can be done, but it means turning the traditional vaccine development model on its head.
In an interview with Stat, Nabel highlighted that the classic response to emerging and infectious diseases, such as MERS and Ebola, has been inadequate. "We just run from one crisis to another. … That's no way to protect the world's population," he said.
The traditional vaccine development timeline typically takes 5 years or more to produce a marketable vaccine, encompassing the development of candidates, identifying which of the candidates to move forward with, preclinical trials, human clinical trials and finally regulatory filing. To have a chance at accelerating this for emerging diseases, biotechs and pharmas, regulators and government agencies need to come together and unpack this model, identifying where time can be saved and exploring different ways to go about clinical trials, Nabel said.
Traditional trial design got in the way for many Ebola vaccine makers in 2015, with GlaxoSmithKline ($GSK), Johnson & Johnson ($JNJ) and Merck ($MRK) having trouble locating enough people with exposure to Ebola for their clinical trials. Merck's jab, the furthest along in development, is en route to file for regulatory approval in 2017 on the strength of a novel Phase III "ring study" developed to surmount this challenge.
"It can't be business as usual," Nabel told Stat, referring to structures that are currently in place to respond to emerging diseases. He identified WHO as "symptomatic of the problem." While it has "the best of intentions," it doesn't have the wherewithal to follow through, he said. The agency has declared Zika a global public health emergency and in February called for $56 million in funding to combat the virus. Just over a month later, only $3 million--5%--in funding has trickled in, according to USA Today.
Sanofi ($SNY) committed to developing a Zika vaccine early on, betting that its experience in dengue vaccine development would give it a head start. The "backbone" it hopes to use in a Zika vaccine has been used safely in millions of patients, and its dengue vaccine facility in France could prove useful in manufacturing a Zika jab.
In the meantime, the U.S. Senate approved a bill to add Zika to the FDA's priority voucher program, which PaxVax CEO Nima Farzan previously told FierceVaccines would create an economic incentive for companies to develop Zika vaccines. Under the program, such a company would be awarded a transferable voucher for expedited FDA review. And across the pond, a University of Manchester team is just the latest to join the teeming Zika race. It joins the NIH and Bharat Biotech, which are leading the charge, as well as Plymouth Meeting, PA's Inovio ($INO) and California-based Vaxart.