Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...
March 2— The GAO's chief scientist questioned whether federal agencies would realistically be able to implement their research agenda for combatting the Zika virus outbreak.
Timothy M. Persons, chief scientist for the Government Accountability Office, told a House oversight panel during a Zika hearing that the research agenda laid out by the National Institutes of Health and the Centers for Disease Control and Prevention is “necessarily ambitious” but that the agencies may face challenges. He also suggested that vaccine development may take longer than the time frame suggested by the NIH.
“These preliminary observations on the Zika virus point to a persistent and urgent need for a proactive, agile, integrated and coordinated set of programs, and research and development including epidemiological studies, mosquito control, modeling and simulation and vaccine development especially in light of other emerging diseases such as chikungunya and Dengue,” Persons said.
Persons' testimony before the House Energy and Commerce CommitteeOversight and Investigations Subcommittee comes as House Republicans are pushing back on the White House's request for $1.9 billion to combat the mosquito-borne virus that has been spreading throughout the Americas and has been declared a public health emergency . Republican leaders, including House Appropriations Chairman Hal Rogers (R-Ky.), want to use unobligated dollars in emergency funding instead of appropriating new money.
Rep. Tim Murphy (R-Pa.), who is the chairman of the House Energy and Commerce Oversight and Investigations Subcommittee, questioned the Obama administration's overall approach to emerging public health threats.
“While the administration's request has worthy aims, its one-off emergency funding approach, like the $6 billion for Ebola emergency funding, demonstrates a reactionary posture towards public health preparedness rather than a strategic one,” Murphy said in his opening statement. “The administration's response to Zika raises very serious questions.”
Nicole Lurie, assistant secretary for preparedness and response for the Department of Health and Human Services, told lawmakers that the president's request includes a $295 million reserve fund for handling urgent and emerging threats.
Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, part of the NIH, told Congress that he has no money left from the emergency Ebola funding, but that he has been moving money around from other funding areas to work on the Zika virus outbreak. The NIH probably has enough funding to set up the initial human testing for a vaccine candidate by conducting animal models over the next six months, he said after the hearing.
“I don’t think we’re going to make the transition from a phase I to a phase II trial or even to complete a phase I without getting new money,” Fauci said in response to a question from Bloomberg BNA.
Drug companies also may back of out of developing a vaccine without the emergency supplemental money, Fauci told the House subcommittee, even though several companies have expressed interest to the NIH in partnering with the agency.
“If it turns out we don’t get the supplement, we will be viewed as an unreliable partner,” he said, adding that a similar situation occurred years ago when developing biodefense countermeasures. “We would start partnering with pharmaceutical companies, and when it looked like we weren’t going to get a particular round of partnership money, they pulled back. That would be the worst thing in the world for us, to have the pharmaceutical companies think we’re not a reliable partner.”
In his written testimony, Persons said there are scientific and structural barriers in testing vaccines in pregnant women and knowledge gaps in understanding the Zika virus. He also noted that late-stage vaccine clinical trials are still ongoing for dengue fever, and that early phase testing began in 1999.
“Zika virus disease poses new challenges to vaccine development and testing,” Persons said in his written testimony.
Fauci said after the hearing that he was hesitant to comment on Persons' assertion that the research plan is ambitious because the GAO scientist didn't lay out a time table in his oral testimony. However, Fauci reiterated previous testimony before Congress that he expects to begin phase I clinical studies of a vaccine candidate by the end of summer or early fall, which means scientists would likely be ready to determine if that candidate is safe and produces a good response by 2017 .
He added that with vaccine development, there's always a chance that something could go wrong that would change the time line. If the outbreak dwindles simply due to controlling the mosquito population or other public health interventions, that would be a great outcome overall, but it would prolong the clinical testing phase, he said.
“You can never, ever guarantee you’re going to get it until you have it. So that’s the challenge. But I think we can do it,” Fauci said, adding that vaccines have been developed for similar viruses such as yellow fever. “There’s no real conceptual reason why we can’t make a vaccine for Zika.”
To contact the reporter on this story: Jeannie Baumann in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Brent Bierman at email@example.com
More information about the hearing is available athttps://energycommerce.house.gov/hearings-and-votes/hearings/examining-us-public-health-response-zika-virus.
Persons' testimony is available at http://docs.house.gov/meetings/IF/IF02/20160302/104594/HHRG-114-IF02-Wstate-PersonsT-20160302.pdf.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)