On July 2, the Biomedical Advanced Research and Development Authority (BARDA) announced a $176 million grant to Moderna to develop vaccines for the current strain of bird flu, H5N1. These critical vaccines could take a year or more to develop and deploy, with late-stage testing expected in 2025. Still, public health experts are increasingly concerned about the lack of bird flu testing. Rick Bright, the former head of BARDA, has called the U.S. lag in testing “woefully inadequate”– recalling troubling similarities to the ultimately disastrous COVID-19 testing delays.
While the CDC currently ranks the risk of a bird flu pandemic as “low”, it is impossible to predict if and when that may change without increased testing. A recent study from Texas suggests that current surveillance may be missing a significant number of cases, indicating that more testing is needed to ensure that the U.S. does not underestimate bird flu infection levels. During the COVID-19 pandemic, Congress authorized additional funding and removed the bureaucratic obstacles to expedite the production of tests and vaccines. One notable initiative, RADx, administered by the National Institutes of Health (NIH), provided funding and regulatory support for private labs developing innovative testing techniques.
However, the delay between the initial warning signs of the pandemic and the subsequent action likely cost tens of thousands of lives. Congress should take proactive measures to avoid similar administrative inefficiency and backlog with H5N1. These include providing advance market commitments to manufacturers for testing and using existing tools to streamline testing efforts.
The state of testing
The coordination of testing for novel pathogens is fragmented and inefficient. This was especially evident during the COVID-19 pandemic, when the CDC rejected the test designed by the World Health Organization’s (WHO) and chose to create its own. As a result, the FDA did not approve tests manufactured by independent labs, leading to a communication breakdown between the two agencies. Consequently, the FDA’ relied on the CDC’s initially faulty COVID-19 test.
This is not the first time that testing fragmentation has resulted in delays. A similar scenario occurred during the 2016 Zika epidemic. In 2016, the CDC introduced a complex test kit for multiple diseases–including Zika–which proved less effective than the previous Zika-only test, missing 40 percent of Zika cases. Despite these issues, the CDC mandated its use for a year.
In the case of COVID-19, it took nearly two years into the pandemic for the U.S. to develop an abundance of rapid tests. Compared to countries like Germany, the United States only adequately invested in rapid tests in the fall of 2021. The initial flurry of COVID-19 response bills required laboratory testing to be free at the point of service for all Americans, ensuring a stable market for laboratory diagnostics and giving manufacturers the certainty needed to produce millions of test kits. However, rapid tests were not included in this requirement, making it difficult for manufacturers to predict future demand. Consequently, rapid tests remained relatively rare until fall 2021, when the Biden Administration directed more funding to the RADx program and pledged to purchase half a million tests.
Many experts have highlighted the troubling similarities between the U.S. government’s response to the current H5N1 outbreak and its mishandling of COVID-19. The U.S. must improve testing coordination to mount an effective response to H5N1. Testing for bird flu is even more fragmented than testing for COVID-19 because this outbreak involves livestock and milk. Different agencies are responsible for viral testing at various stages: The USDA tests live cows, the FDA tests milk products, and the CDC tests humans. This fragmented approach complicates coordination, as positive tests in livestock do not automatically trigger testing for farm workers exposed to those animals.
The CDC claims to have distributed 750,000 non-rapid tests to labs nationwide for human testing. State public health agencies can then use these tests on farm workers. However, since March 2024 (when the first human case was discovered) the CDC has reported performing 60 tests on humans in the U.S., detecting 13 human cases of H5N1. States with outbreaks have reported 99 total tests, including those for people exposed to other sick animals, which likely overlap with tests administered by the CDC. Moreover, the CDC tests are limited to people exposed to cattle. This approach does not detect all cases. The University of Texas discovered antibodies against the virus in two out of 14 previously untested workers from just two dairy farms with outbreaks.
The CDC has also permitted eight labs to manufacture tests using its design. However, each lab must undergo an FDA approval process to begin manufacturing tests, which could take months or years. Furthermore, the FDA recently announced a final rule requiring more premarket testing, increasing the regulatory barriers to creating new diagnostic tests. Although this rule will not go into effect until 2025, labs are already designing their tests with these new requirements in mind. This process could be significantly expedited if the FDA granted Emergency Use Authorizations (EUA) to these labs, lowering the evidence threshold required for approval, as it did for devices related to COVID-19.
Currently, testing is conducted by state public health labs using the CDC’s test. The states send presumptive positive samples to the CDC for confirmation and genetic sequencing. While the 750,000 tests the CDC has distributed are sufficient for the low demand, this could change quickly. During the peak of the COVID-19 pandemic, labs performed more than two million tests a day. However, the CDC is not designed to be a high-capacity manufacturer of tests; that role belongs to private labs and manufacturers. Currently, only the CDC has FDA approval to manufacture tests, which means that if states suddenly needed more, there would be significant delays.
Rapid tests can help fill the gaps in the current testing strategy because they do not require constant contact with the medical system to be used regularly. The U.S. must begin developing and distributing these rapid tests to understand the severity of our H5N1 outbreak better.
Policies to increase testing moving forward
The Department of Health and Human Services (HHS), the agency encompassing the FDA, CDC and NIH, can expedite developing and approving various diagnostic tools. Congress and HHS should urgently consider the following to increase testing for bird flu:
- Buy and distribute existing rapid influenza tests. During the pandemic, the NIH spent $500 million designing the aforementioned RADx program to fund research into different types of COVID-19 tests, including at-home rapid tests. The program produced combination flu and COVID-19 tests that can distinguish between Influenza A and B(the former being a potential indicator of H5N1 during the summer months). Congress should similarly appropriate money to buy and distribute these tests to farm workers.
- Issue an Emergency Use Authorization. The HHS Secretary can issue an Emergency Use Authorization for diagnostics to accelerate the testing process. Doing so would enable the FDA to expedite the approval process. During the COVID-19 pandemic, the FDA provided templates for labs to use for their tests, speeding up approval time and lowering the administrative burden on labs. HHS should consider offering similar resources to labs today.
- Offer advance market commitments to build on the success of RADx to develop new H5N1 tests. With additional congressional funding, NIH could relaunch the RADx program to help labs develop H5N1-specific tests. Congress should offer advance market commitments to ensure manufacturers will be compensated because it is still being determined how many bird flu tests we will ultimately need. Doing so provides the government with enough tests to cover the worst-case scenario of a widespread outbreak while motivating labs to produce them.
Despite the delays, the U.S. was eventually able to produce and distribute large quantities of COVID-19 tests by working around the rigid bureaucracy. Those same tools are currently at the disposal of U.S. public health authorities. While BARDA has accelerated vaccine development, we must commit resources to test for H5N1 adequately. To do this, utilizing existing effective diagnostic tools and initiating advance market commitments for testing is critical. Of course, the hope is that these tests will ultimately not be needed. Still, given that scaling up production is expensive and time-consuming, being proactive is critical to ensuring the U.S. is well-equipped if H5N1 ever becomes a more significant threat.