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The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress.
The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress, as seen in new policies to spur R&D and added funding for these efforts. The secretary of Health and Human Services (HHS) recently issued a formal declaration under the Public Readiness and Emergency Preparedness (PREP) Act that prevents liability claims against US firms involved in the manufacturing, testing, development, distribution, and administration of Ebola vaccines. It applies specifically to new vaccines being developed by GlaxoSmithKline, NewLink Genetics with Merck, and Johnson & Johnson’s Janssen Corp. with Bavarian Nordic.
At the same time, Congress rushed through legislation enhancing incentives for developing new Ebola therapies by permitting the Food and Drug Administration to award priority review vouchers to sponsors of such treatments. The measure adds Ebola to the list of neglected tropical diseases that qualify for the vouchers, which can be used or traded to gain a fast priority review by FDA for another new drug. The measure also makes it easier for FDA to add other tropical diseases to the voucher list and provides more flexibility in using and trading vouchers.
Congress also is approving $5.2 billion in emergency funding for Ebola prevention and treatment efforts. It’s less than the amount requested by the White House, but still provides $25 million to FDA to support expedited oversight and authorization of clinical trials for new vaccines and antivirals. FDA has been caught up in the debate over the ethics and value of randomized clinical trials for experimental Ebola therapies. Agency officials maintain that RCTs are necessary to determine the true effects of any new treatment, while authorities in Europe are authorizing studies without placebos. Early safety studies and immune response of experimental vaccines have been sufficiently positive to prompt initial steps in designing larger clinical trials, and a complex, multi-product study is planned for several promising therapies.
The increased support for combating the Ebola outbreak is sufficiently robust to now generate concerns that all this investment is diminishing resources available to continue developing new treatments for more lethal and widely spread diseases-namely AIDS, malaria and tuberculosis. At the same time, the Ebola campaign provides an opportunity to expand R&D in multiple third-world diseases, and for pharma companies to demonstrate their ability to bring multiple important new therapies to market to enhance public health around the world.