- The Washington Times - Wednesday, August 3, 2016

The Obama administration said Wednesday it is starting the first stage of human trials for a Zika vaccine but fears there will not be a second phase unless Congress breaks an impasse over federal funding to combat the mosquito-borne disease.

Health and Human Services Secretary Sylvia Mathews Burwell said the National Institutes of Health will by Aug. 31 exhaust its $47 million share of $374 million that had been redirected to the domestic Zika response.

The NIH is ready to start injecting 80 volunteers with its trial vaccine for Zika — a phase-1 effort that is seeming more urgent by the day, as Florida officials confirm the first batch of locally acquired cases in the continental U.S.

“Without additional funding, the second phase of clinical trials that NIH is planning to conduct for this vaccine and others will be delayed,” Mrs. Burwell said. “A delay in this stage of development will delay when a safe and effective Zika vaccine is available to the American public.”

Several private companies are chasing a vaccine, too, though Mrs. Burwell said the government arm that supports their efforts is about to run out of it $85 million share of Zika money.

The Centers for Disease Control and Prevention, meanwhile, has spent more than half of the $222 million it received to protect U.S. shores from the virus, she said. It is poised to spend the rest by the end of the fiscal year on Sept. 30.

Mrs. Burwell’s letter to the chairmen of Congress’ spending committees is a direct response to GOP complaints that President Obama is sitting on millions in unspent dollars earmarked for Zika, even as he asks Capitol Hill to take up his $1.9 billion request for additional funding.

“The department is committed to using scarce federal dollars aggressively and prudently, especially in light of Congress’s inaction to provide any additional resources and the uncertainty around whether Congress will provide resources in the future,” Mrs. Burwell said.

Republican leaders say they did their part by offering $1.1 billion in extra Zika money before Congress’ seven-week recess, only to see Democrats block the deal over provisions that rolled back environmental protections and boxed out Planned Parenthood from its birth control plans.

The GOP paid for $750 million of its package by taking money from the Ebola fight, Obamacare and other accounts.

Democrats want Republicans to return to Capitol Hill and renegotiate a package that offers at least $1.1 billion without swiping funds from other places in the federal budget, meaning taxpayers would have to pay for it later.

Reports of the first Zika cases by mosquito bite on the U.S. mainland are fueling the election-year fight.

Until last week, the CDC was able to link more than 1,650 Zika cases in the states and District of Columbia to people who had returned from countries where the virus is circulating, plus one case of accidental laboratory infection, although mosquitoes have infected more than 5,000 on Puerto Rico.

Sen. Marco Rubio, Florida Republican who initially backed Mr. Obama’s Zika request for $1.9 billion, said reports that 15 people picked up Zika in the artsy Wynwood neighborhood of Miami underscore the need for more funding, both to protect pregnant women and local businesses that have temporarily closed amid the small outbreak.

“It reminds us that Zika is not just a public health emergency, it’s also an economic one,” Mr. Rubio said Wednesday in front of television cameras at his office in southern Florida. “We’re very concerned about the impact this has, ultimately, on Florida’s tourism.”

Mr. Rubio recently blasted the Obama administration for its “apparent lack of urgency and speed” in spending down dollars that were reprogrammed from the Ebola fight in West Africa and other accounts earlier this year.

The administration says it shouldn’t have to choose which health threats it tackles, so it is pleading for more cash without strings attached.

“I want to urge you to work with your leadership to develop a bipartisan bill that will allow us t-g mount the full and timely response to the Zika virus that the American people deserve,” Mrs. Burwell said in her letter to appropriators.

Zika has already ravaged Brazil and other Latin American countries, where scientists first detected a link between the outbreak and the rate of babies born with abnormally small heads, a condition known as microcephaly.

“A safe and effective vaccine to prevent Zika virus infection and the devastating birth defects it causes is a public health imperative,” Dr. Anthony S. Fauci, NIH’s infectious diseases director, said in announcing the agency’s vaccine trials.

NIH’s vaccine candidate includes a piece of DNA known as a “plasmid” that has been engineered in a way that causes the body to produce an immune response to Zika. It does not contain infectious material and cannot cause a recipient to become infected with Zika, according to NIH.

NIH will use a needle-free injector to push the vaccine fluid in participants’ arm muscles. The volunteers are broken into separate groups so that scientists can experiment with the frequency and timing of doses.

Result of the phase-1 trial are expected by January 2017. If promising, NIH will launch a phase-2 trial in countries where Zika is prevalent in early 2017.

“Although it will take some time before a vaccine against Zika is commercially available, the launch of this study is an important step forward,” Dr. Fauci said.

Several entities are racing to develop a Zika vaccine, as Florida’s outbreak creates headlines and Rio de Janeiro kicks off the Olympic Games this weekend in hard-hit Brazil.

Inovio Pharmaceuticals said it dosed the first of 40 participants last week in a phase-1 trial of a vaccine candidate it developed with GeneOne Life Science, Inc. The study will be conducted in Miami, Philadelphia and Quebec City, Canada.

Sanofi, a French company, agreed last month to work on a Zika vaccine with the Walter Reed Army Institute of Research in the U.S.

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