Preparing for the Next Major Outbreak
Pondering the need for an independent global agency to coordinate international vaccine and antibody manufacturing efforts
Source: Daniel Stowell/CDC. Public Domain image
The 2014 Ebola outbreak in West Africa affected 28,616 people and claimed 11,310 lives before basic containment efforts stopped the epidemic. Although the results of a phase 3 clinical trial, published last December in The Lancet, showed that an experimental vaccine was highly protective against the deadly virus, it came too late to be useful in the recent outbreak, and no Ebola vaccine has yet been approved by the U.S. Food and Drug Administration.
The recent spread of the Zika virus, and its association with severe pregnancy complications such as microcephaly, with children born with unusually small heads, is another reminder of the world’s persistent lack of preparedness to rapidly deal with emerging infectious diseases. Although a number of initiatives are underway to tackle this problem, they are likely to fall short without the oversight of an independent global agency that would coordinate efforts among vaccine and antibody manufacturers across countries. This is the stark assessment of a perspective article published online April 10 in Proceedings of the National Academy of Sciences.
“I wanted to bring to the attention of the broad scientific community and policymakers that emerging infections will continue to come, possibly at an increased pace, and that the reactive system we used so far is useless,” said perspective co-author Rino Rappuoli, chief scientist at GlaxoSmithKline Vaccines. “I also wanted to point out that there are some proposals like CEPI [the Coalition for Epidemic Preparedness Innovations] and BPO [biopreparedness organization]. These are good initiatives, but not good enough to provide a broad solution.”
New vaccine development can focus on the safety and efficacy of the inserted gene, and a single plant can be ready to produce multiple vaccines at any time, allowing a faster response to an unanticipated threat.
Originally proposed by GlaxoSmithKline, a dedicated BPO would be a nonprofit, separate legal entity fully embedded within an experienced industrial research and development organization. Drawing on long-term funds from public and philanthropic organizations such as CEPI or the U.S. Biomedical Advanced Research and Development Authority, the BPO would develop two or three vaccines on an ongoing basis to clinical proof of concept and maintain an adequate supply of clinical materials for a subsequent evaluation of efficacy, and potentially a large enough supply for an emergency intervention.
One BPO idea is to convert a GlaxoSmithKline plant in Rockville, Maryland, into a major facility for producing vaccines against emerging infectious diseases using cost-effective, plug-and-play platform technologies. These platforms use a module based on a viral vector, synthetic DNA or RNA, or a bacterial construct to deliver a synthetic gene that encodes an immunity-inducing agent or nanoparticles containing an antigen. The major advantage of these platforms is that once they have been developed and licensed for one vaccine, development of the next vaccine requires only substitution of the synthetic gene. New vaccine development can focus on the safety and efficacy of the inserted gene, and a single plant can be ready to produce multiple vaccines at any time, allowing a faster response to an unanticipated threat.
According to the perspective authors, the global health community should work together to institute, fund and support a BPO or other organization that can oversee and promote global epidemic preparedness. “I hope that CEPI will be able to step up and become a global agency able to coordinate the effort on a global scale,” Rappuoli said.