Imagine sitting across from a young woman who recently returned from visiting her aging grandmother in Puerto Rico, and who has just learned that she is pregnant.
As a volunteer physician in a local community clinic, this is an easy scenario for me to picture. I would need to explain to her that Zika virus is spreading rapidly in Puerto Rico, and that if she had become infected, there is a chance that her baby could have a birth defect caused by Zika.
{mosads}I’d like to be able to test her for Zika right there in the office, but there is no such rapid test. I’d like to be able to draw her blood and call her tomorrow with the test result, but if a pregnant woman in the United States gets tested for Zika today, it can take as long as four weeks to learn whether or not she has been infected with the virus.
As a primary care physician, I know that’s an excruciating wait for vital information.
In my role as the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), I also know that developing medical countermeasures quickly — whether diagnostic tests, vaccines, or treatments — is essential to responding to a new infectious disease.
At HHS, I also lead the Public Health Emergency Countermeasure Enterprise (PHEMCE), consisting of all U.S. government agencies involved in research and development of medical products, like the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), ASPR’s Biomedical Advanced Research and Development Authority (BARDA), the Centers for Disease Control and Prevention (CDC), and the Department of Defense.
Since early 2016 — well before the first travel-associated case of Zika arrived in Florida or New York — the PHEMCE has led strategic and coordinated Administration-wide efforts to develop new Zika tests and to increase access to diagnostic testing.
Because four out of five people infected with Zika do not develop any symptoms and thus never know they had it, we needed to develop two different types of diagnostic tests for the virus: one to assess whether someone currently is infected Zika, and one that can determine whether someone has had Zika recently. We’ve made enormous progress in the last few months.
In February, scientists at CDC developed the first test for Zika infection to be authorized by the FDA for emergency use. In March, a second CDC test became available for emergency use. CDC has provided these tests to qualified public health laboratories throughout the United States and around the world to help expand access to testing. However, the test results take time.
We also have been working closely with partners in the private sector to encourage and support the development of commercially available Zika tests, further expand access to testing, and increase our testing capacity in the United States. This summer, CDC provided one of their Zika tests to qualified commercial laboratories, allowing these labs to offer the test until others are more widely available.
Meanwhile, ASPR’s BARDA has been working with private sector test developers to help solve and remove the scientific and market barriers to Zika test development. We are bringing key industry players to the table, conducting market research, coordinating with government partners, and funding development. Since April, BARDA has awarded $85 million to support critical private sector Zika research and development work, including contracts with companies to develop faster Zika diagnostic tests that can provide results within 30 minutes and be performed at a doctor’s office.
Early in the Zika outbreak, test developers did not have enough samples of Zika-infected blood to validate the accuracy of their tests. BARDA quickly contracted to collect blood samples from people who have been infected with Zika and, together with CDC, has been making them available to diagnostic test developers so they can demonstrate whether their tests work.
To date, FDA has issued emergency use authorizations for eight commercially available Zika tests. With the tests now available under emergency use, health care laboratories have begun to offer Zika testing throughout the United States, speeding up the time to get Zika test results to patients. Work on these tests continues so the companies can apply to FDA for full approval of the tests. In the pharmaceutical industry, roughly 80 percent of products don’t make it through development; the science just doesn’t work out. There are more are in the development pipeline because having multiple products in pipeline increases the likelihood that at least one will succeed.
Private sector partners have stepped forward to help, but the Department’s Zika resources are virtually depleted. Congress failed to pass emergency Zika funding, and this forced the Administration to choose between delaying critical diagnostic and vaccine development work for Zika or raiding other worthy programs, such as ongoing efforts to develop Ebola vaccines.
Today, we are able to support key companies that have partnered with the U.S. government to develop Zika vaccines and diagnostics, but funds will be exhausted by September 30 when the fiscal year closes. Indeed, concerns about the limited and uncertain funding situation have caused several vaccine developers to consider abandoning their efforts and at least one manufacturer to withdraw from negotiations.
We are working to accelerate critical Zika vaccine and test development, but need additional funding from Congress to support the private sector partners who have come to the table. Otherwise, they may not have the resources they need to continue their work. We stand ready to work with Congress, and urge them to work on a bipartisan bill that will allow us to mount the comprehensive Zika response that Americans deserve.
Nicole Lurie, M.D., is the assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services
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