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Sept. 29 — Zika money provided in the stopgap bill allows the NIH to continue vaccine work, but the agency still can't repay about $92 million it has borrowed in lieu of an appropriation.
President Barack Obama signed into law Sept. 29 the continuing resolution ( H.R. 5325) that funds the government through Dec. 9, avoiding a government shutdown just one day before the 2016 fiscal year ends Sept. 30. That spending package included $1.1 billion to combat the Zika virus, which became a partisan battle this summer over disagreements on how to pay for the $1.9 billion in emergency funding the White House requested in February. The measure also included $37 million to address the nation’s opioid epidemic.
“I’m obviously relieved that we’re getting the money that we absolutely need, to continue the work that we started on borrowed money,” Anthony S. Fauci told Bloomberg BNA. Fauci is the director of the National Institute of Allergy and Infectious Diseases (NIAID) and has been leading the National Institutes of Health's Zika response. “We're in the middle of a phase I trial that’s going very, very well. It would have been a shame to interrupt the momentum and the flow.”
Out of the $1.1 billion, the NIH will receive $152 million for the Zika response, which includes work to develop a Zika vaccine, research to learn more about the virus and a “variety of other things,” Fauci said. The funding prevented a possible halt in the NIH's ability to respond to the virus outbreak, which has been linked to serious birth defects.
The White House initially requested $200 million for the NIH back in February. When asked if the appropriation in the continuing resolution was enough, Fauci said it depends on what happens with the Zika virus epidemic. But he said the $152 million will allow the agency to continue with the most critical work of developing a vaccine for the Zika virus.
“I would say it is enough to do the most important thing, but not to do everything we had planned to do,” he said.
Without the continuing resolution, Fauci said, the NIAID would not have been able to conduct a phase II trial on a vaccine candidate that currently is in the preliminary human testing phase. The phase II clinical trial is a critical step because that is when scientists determine if the vaccine works, Fauci explained.
The current phase I testing will administer the vaccine to 80 health healthy adults. The phase II trial will take place where there is a Zika outbreak and will involve anywhere from 2,400 to 5,000 individuals, he said.
There has been no work stoppage in the vaccine development, Fauci said, and a phase II trial is set to begin in early 2017. “We used the frantic spending of borrowed money to do everything we felt needed to be done so we would not lose any momentum,” he said. “If we did not get a CR, then there would have been a lot of things that we didn’t do.”
But the $152 million isn't enough for the NIAID to pay back any of the money the institute has borrowed to work on Zika.
“We spent $11 million of our own money in the very beginning,” Fauci said, referring to 2015 when Zika was first identified in Brazil.
“We spent $47 million from Ebola, and we spent $34 million that we took from other institutes,” Fauci said, which all together totals about $92 million. “And there is no provision in the continuing resolution nor in the Zika funds to pay any of that back.”
In August, Health and Human Services Secretary Sylvia Mathews Burwell used her secretarial authority to transfer the funds within different accounts within the NIH, including transferring $7.2 million in cancer research and $2.5 million in diabetes research.
A number of health and research groups hailed the inclusion of Zika funding in the continuing resolution.
Mary Woolley, president and chief executive officer of Research!America, said the stopgap spending bill is a crucial step toward completing work on federal spending bills this year “rather than passing the buck to the next Congress.”
“Major health threats like Zika require an immediate and robust response to prevent the spread of a virus that is endangering pregnant women and children, and society at large,” Woolley said in a Sept. 29 statement. “Adequate federal funding will help speed the development of a vaccine and provide more resources to states to protect citizens.”
“Many other initiatives underway to prevent and halt the progression of deadly diseases such as Alzheimer’s and cancer need sufficient federal support in the FY17 budget,” she said.
Darrell G. Kirch, president and CEO of the Association of American Medical Colleges, also referenced Zika funding in applauding passage of the bill.
“Congress also included critical support for Zika response, with funding for vaccine development and diagnostics and other related research through the National Institutes of Health (NIH); vaccine development through the Department of Health and Human Services Biomedical Advanced Research and Development Authority; and $6 million to assign National Health Service Corps clinicians, including pediatric subspecialists, to affected areas to combat the spread of the disease,” Kirch said in a Sept. 29 statement. “We strongly urge Congress to pass a full omnibus spending bill when they return in the fall that funds all other agencies through FY 2017 and includes the Senate-proposed $34.1 billion for NIH.”
Andrew W. Gurman, president of the American Medical Association, said the funds will provide resources necessary to help contain the virus and limit further impact on Americans.
“It has been clear over the past several months that the U.S. has needed additional resources to combat the Zika virus,” he said in a Sept. 29 statement. “With the threat of the virus continuing to loom, this funding will help protect more people—particularly pregnant women and their children—from the virus’ lasting negative health effects.”
The March of Dimes issued a press statement with the e-mail subject line, “It's about time ... Congress Passes Zika Funding” after the Senate passed the bill on Sept. 28.
Jennifer L. Howse, president of the March of Dimes, said passage of Zika funding is only the first step down a very long road.
“At this time, there are more than 2,000 pregnant women with possible Zika infection among the 23,000 infected people in this country, and the epidemic shows no sign of slowing,” she said in a statement.
“Resources are desperately needed to fund the elimination of Zika-carrying mosquitoes, development of a vaccine, and delivery of appropriate health care to affected children and families. In the coming years, a sustained commitment will be critical to control the spread of Zika and deal with its aftermath,” Howse said.
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The continuing resolution is at https://www.congress.gov/bill/114th-congress/house-bill/5325/text.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
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