On Meet the Press yesterday, Anthony Fauci was asked whether it was “hyperbole” that the world would have an Ebola vaccine today if Congress had more generously funded the U.S. National Institutes of Health (NIH). “You can’t say we would or would not have this or that,” said Fauci, who heads NIH’s National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, a leading supporter of Ebola vaccine research.
A week earlier, here’s what Fauci’s boss, NIH Director Francis Collins, told The Huffington Post: “Frankly, if we had not gone through our 10-year slide in research support, we probably would have had a vaccine in time for this that would've gone through clinical trials and would have been ready.”
NIAID’s high-profile director challenging the NIH director is the kind of political contretemps that easily explodes into a great inside-the-Beltway brouhaha. Witness the story in The Washington Post story today, “A public dispute between NIH officials over Ebola,” that references several other related stories.
As it turns out, Fauci and Collins agree that big pharma’s lack of interest in Ebola vaccine development is the main reason no product was ready for this epidemic.
In 2000, NIH researchers published the first convincing evidence that an Ebola vaccine—built around an adenovirus “vector” that carried a gene for the Ebola surface protein—could protect monkeys. A review article about the field in 2003, co-authored by leading Ebola vaccine developer Thomas Geisbert now at the University of Texas Medical Branch in Galveston, noted that the “small global market has generated little commercial interest.” But preclinical research into different Ebola vaccines, in part funded by NIAID, continued apace. Five years later, in a study that used the vesicular stomatitis virus (VSV) as the vector for an Ebola gene, Geisbert and co-authors wrote: “Remarkable progress has been made over the last few years in developing candidate preventive vaccines that can protect nonhuman primates.”
Geisbert told ScienceInsider he “completely” agrees with Fauci’s assessment. “His comment is spot on,” Geisbert says. “The smaller companies that were working on Ebola vaccines and treatments did not have the financial resources” to make the clinical grade product needed to stage human studies. NIH funding typically supports research, not product development.
There were also problems with the strain of adenovirus that served as a backbone of the NIH vaccine in the 2000 experiment—known as Ad5. It was also used in an AIDS vaccine, but in 2013 was clearly linked to increased risk of transmission of HIV. Researchers using Ad5 for other vaccines promptly dropped it; NIH’s current Ebola vaccine now in early human trials uses a chimpanzee adenovirus. If NIH had invested in the scale-up of the Ad5-based Ebola vaccine, the vials may well have ended up in the trash.
Geisbert’s VSV approach was funded primarily by the Public Health Agency of Canada, not NIH. That vaccine entered human trials last week. Geisbert is now pursuing yet another VSV vaccine, made by Profectus Biosciences in Tarrytown, New York and Baltimore, Maryland, that he believes has a better safety profile.
Collins says he and Fauci agree that if the NIH had not lost “purchasing power” over the past decade, “NIH-funded Ebola research would be further along,” he wrote ScienceInsider in a statement. “[C]onstrained resources have slowed the process in developing an Ebola vaccine,” he wrote. But Collins backpedaled on his earlier comment, echoing Geisbert. “Because of the extremely limited market potential prior to the 2014 outbreak, there was little industrial interest in an Ebola vaccine,” he noted. “So while NIH readiness might well have advanced to a later stage without the budget situation, it would still have been difficult to have hundreds of thousands of doses of a vaccine in vials, ready to administer.”
*The Ebola Files: Given the current Ebola outbreak, unprecedented in terms of number of people killed and rapid geographic spread, Science and Science Translational Medicine have made a collection of research and news articles on the viral disease freely available to researchers and the general public.