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Capitol Checkup: Platforms urged over stockpiles; Collins confident on tax deal

In recent years when new emerging infectious disease outbreaks have erupted, like those involving the Ebola and Zika viruses, biopharmaceutical makers and government agencies have rushed to urgently develop vaccines to fight the threats — often only to have many of those products shelved once the immediate crisis was over.

But with various public health groups and researchers warning that the world is unprepared for the next big pandemic, drugmakers and various organizations are increasingly moving towards platform technologies intended to more rapidly develop vaccines that can be scaled up quickly to respond to outbreaks, rather than pursuing specific products for government stockpiling in anticipation of an epidemic that may never emerge, said Ripley Ballou, head of GlaxoSmithKline plc's global vaccines research and development center in the U.S.

Using the platforms approach could significantly accelerate the availability of vaccines during emergencies, Ballou told S&P Global Market Intelligence.

"What we think needs to happen is to prepare for the unpredictable and focus on the development of platforms that are capable of going from genetic information and quickly to something that could go into the clinic," he said. "We are talking about a scenario where we don't really know what's coming until it happens."

GSK was one of the early companies that jumped into action on vaccines to confront the 2014-2015 Ebola outbreak in West Africa and the Zika epidemic that spread from South America to North America in 2016.

But with both of those outbreaks declared over and no longer emergencies, GSK set its work on its Ebola and Zika vaccines aside for the time being, Ballou acknowledged.

The company, however, is moving full-speed ahead on the chimpanzee-derived adenovirus and the self-amplifying mRNA, or SAM, platform technologies on which those Ebola and Zika vaccines, respectively, were based, Ballou said.

In addition to using those platforms for emerging infectious diseases, the company plans to also pursue commercial products with them.

GSK's Ebola vaccine, which it developed with the National Institutes of Health, got as far as phase 2 testing, with results in February 2016 showing that the product was well-tolerated and induced an immune response.

The Zika vaccine, which also was being developed with the NIH, was "very promising" in animal testing, but has yet to be studied in humans, Ballou said.

The company is anticipating launching an initial proof-of-principle study in humans of the SAM platform technology in early 2019, he said.

GSK is seeking financial support on its platforms strategy from the Biomedical Advanced Research and Development Authority, or BARDA, Ballou said. The U.S. agency, part of Health and Human Services, supports the transition of medical countermeasure candidates like vaccines, drugs and diagnostic tools from the early stages of development into advanced development towards Food and Drug Administration approval and potential procurement through direct funding, public-private partnerships and technical core service assistance programs.

"We are in discussions now with BARDA to align on a proposal that would potentially make this happen," Ballou said. He emphasized that the talks with the government agency were still in the early stages.

BARDA, however, may not be able to help GSK until the agency gets its own funding renewed by Congress. The current law that authorizes the agency's activities is due to expire by the end of September 2018.

BARDA also was among the groups GSK had discussed its proposal with of creating a dedicated, permanent organization operating on a no-profit, no-loss basis and focused on designing and developing new vaccines against potential public health threats.

Ballou said GSK also discussed the idea with the Coalition for Epidemic Preparedness Innovations, or CEPI, which was launched in January with $460 million from the governments of Germany, Japan and Norway, plus the Bill & Melinda Gates Foundation and the Wellcome Trust.

GSK, which is a member of the CEPI partners forum, initially had proposed basing the so-called biopreparedness organization at its fairly new Rockville, Md., vaccines facility, which Ballou oversees.

But the price tag of operating such an endeavor at the facility — which opened a year ago with about a dozen employees and has grown to about 400 — turned out to be above what the company was willing to support, he said.

"That has led us to scale back the scope of what it is we are proposing but not the key elements of what that proposal should involve, which is there should be a focus on capabilities that would allow a rapid response," Ballou said.

Collins sure of health agreements, but not vote

Meanwhile in Washington, Sen. Susan Collins, R-Maine, said she was confident commitments she received from the Republican Senate and House leaders would be kept on, ensuring two bills aimed at stabilizing the individual health insurance market and offsetting premium increases would be adopted by both chambers before Congress votes on its final tax legislation.

Speaking on CBS' "Face the Nation" Dec. 10, Collins said she also was "absolutely confident" there would not be any automatic cuts to Medicare if the Republican tax bill is enacted.

While Collins voted in the Senate in favor of the Republican tax bill based on the assurances she received from Senate Majority Leader Mitch McConnell, R-Ky., and House Speaker Paul Ryan, R-Wis., she said she has not yet made a decision on where she will stand on the final version of the legislation once Republicans work out the differences of their respective bills.

The Republican House and Senate negotiators are working to get those differences ironed out before the end of this week, with expectations of voting on the final bill before Congress takes its winter holiday break.

"I always wait until the final version of the bill is brought before us before I make a final decision on whether or not to support it," Collins said.

The version of the tax bill that passed the House is expected to trigger the budget pay-as-you-go, or paygo, rule, which would slice 4% from Medicare's spending in 2018, according to the Congressional Budget Office.

But Collins said McConnell and Ryan have agreed to again waive the paygo rule — an action that already has been taken 16 times.

The Maine senator emphasized that she had those commitments in writing from McConnell and Ryan.

McConnell agreed in his statement to support the passage of the two healthcare measures "prior to the adoption of any final tax reform conference agreement and certainly before the end of this year."

The first health bill, authored by Sen. Lamar Alexander, R-Tenn., and Sen. Patty Murray, D-Wash., would restore for two years the ACA's cost-sharing reduction payments — subsidies Trump cut off in October after declaring them bailouts for the insurance industry.

The other bill, cosponsored by Collins and Sen. Bill Nelson, D-Fla., seeks to establish a two-year $4.5 billion reinsurance fund intended to offset the costs of covering high-risk individuals.

"I've had a lot of conversations not only with my colleagues in the Senate, but with my colleagues on the House side, and with the White House," Collins said. "I've talked to the president three times about this issue. And once again, I have no reason to believe that that commitment will not be kept. After all, who wants to see health insurance premiums become more unaffordable than they already are for individuals who are buying insurance in the individual market?"

The two bills would "exert downward pressure on premiums and make it more affordable," Collins insisted.

Ryan suggested during his Dec. 9 briefing with reporters that he was not a party to any agreement on the health bills, declaring he "wasn't part of those conversations."

But he also said Collins had "put some very productive, constructive solutions on the table."

"Our members are looking at the same kinds of solutions," Ryan said.

The Senate's version of the tax bill includes a provision that would eliminate the Affordable Care Act's individual mandate, which requires eligible Americans to buy healthcare insurance or pay a tax penalty.

The CBO recently said repealing the ACA individual mandate would result in 13 million fewer Americans with healthcare insurance by 2027, 4 million of those in 2019 alone. It also said Americans in the individual market would see their insurance premiums hiked by 10% in most years of the decade if lawmakers nixed the mandate.

But Collins argued that a new study from Avalere Health showed that her bill would "more than offset the repeal of the individual mandate."