Breakthroughs Blog: BARDA

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.On Wednesday the National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx) initiative, a US$1.5 billion effort to develop new diagnostic technologies for COVID-19 in partnership with the US Food and Drug Administration (FDA), the US Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA). As part of RADx, NIH will host a $500 million challenge seeking promising proposals for point-of-care and at-home diagnostic tests. "We need all innovators, from the basement to the boardroom, to come together to advance diagnostic technologies, no matter where they are in development," said NIH Director Francis Collins. Finalists who are awarded funding will be paired with technical, business, and manufacturing experts to complete develop their products.The NIH National Institute of Allergy and Infectious Diseases (NIAID) and Gilead announced hopeful results from separate clinical trials of Gilead's drug remdesivir, the broad-spectrum antiviral initially developed by Gilead to treat the Ebola and Marburg viruses, against COVID-19. According to NIAID, the drug compared to a placebo reduced median time to recovery from 15 to 11 days, and results suggest the drug had a small positive effect on survival rate. These results aren’t game-changing, but in combination with results reported from a separate trial run by Gilead with similar outcomes, were enough for FDA to grant an emergency use authorization for remdesivir last Friday.The Trump Administration is reportedly planning ways to drastically accelerate the development of a SARS-CoV-2 vaccine through a program called Operation Warp Speed. The program will convene pharmaceutical companies, government agencies, and the military with the audacious goal of cutting the development timeline of a vaccine by as much as 8 months and producing 300 million vaccine doses by the end of 2020. Through Operation Warp Speed the government will absorb the cost of evaluating several vaccine candidates simultaneously, first in animal models, then in one large human master protocol trial that will evaluate several candidates concurrently. After filtering the pipeline, top candidates will enter late-stage clinical trials while the government invests in advanced construction of manufacturing facilities to ramp up mass production of the vaccines before knowing if they are safe and effective.The Jenner Institute, a nonprofit vaccine developer based at Oxford University, has leaped ahead in the race to develop a SARS-CoV-2 vaccine. According to The New York Times, the Institute, having already shown in previous trials that similar inoculations are safe, plans to enroll 6,000 people in a clinical trial by the end of next month to test the vaccine’s efficacy, putting it ahead of other vaccine trials. Pending emergency approval from regulators, the developer say they could have several million doses available by September. The technology in use has been in development at the Jenner Institute for decades in attempts to create a malaria vaccine.

Aedes Aegypti mosquito which carries the Zika virus. Photo: CDC/James GathanyOn Tuesday, the Obama administration announced that it will transfer nearly US$600 million in remaining Ebola funds to fight the growing threat of Zika virus. But many questions remain. Where is the money going? From what accounts will it come? And what does this mean for the Global Health Security Agenda (GHSA) programming which is supposed to help protect against these threats in the future?In February, the President requested $1.9 billion in emergency appropriations to combat the Zika virus outbreak, but authorization was stalled by members of Congress who suggested the Administration reallocate existing funds instead. The Administration continues to stress that the full request is still needed to fight both Zika and complete the Ebola response. With the announcement of the transfer of funds, the Administration is signaling that the risk of waiting for Congress to act on a supplemental funding is too great, and deploying additional funding to address Zika is essential in the short-term—before the summer weather leads to a broader spread of the mosquito-carried virus.Reallocating Ebola funding to address Zika carries consequences. While the Administration acknowledges that some Ebola funds remained unspent, much of this money has been allocated to implement the GHSA—a commitment to help at least 30 countries prevent, detect, and respond to emerging disease threats. GHSA has not received any direct appropriations, largely due to sentiment that remaining Ebola balances should cover the cost. Additionally, as the Ebola response remains unfinished—health systems in West Africa remain fragile and we have not yet developed approved Ebola vaccines or treatments—diverting funding before we have finished the job remains risky.Where is the money going? From where will it come? Vaccine researcher. Photo: NIAID, NIH Because the US Centers for Disease Control and Prevention (CDC) is focused on research and development (R&D) for Zika vaccines, treating those infected, and combating the mosquitoes that spread the virus, many expect the bulk of the $600 million transfer to be directed to CDC Zika efforts. The Washington Post reports that 75 percent of the transfer will go to CDC and the rest to foreign aid accounts. It remains uncertain from what accounts the Ebola transfers will come—and subsequently the impact on programs currently funded through the Ebola supplemental. It seems likely that much of the transfer may come from accounts at the US Agency for International Development and State Department, which as of December 31, 2015, had $400 million in programmed Ebola funds that will expire at the end of fiscal year 2016. Other accounts with remaining funds include: $1.031 billion at CDC for domestic, international, and global health security $363 million at Public Health and Social Services Emergency Fund, which houses the Biomedical Advanced Research and Development Authority $45 million at the US National Institutes of Health $14 million at the US Food and Drug Administration Funds in these accounts do not appear to have expiration dates. As we do not yet know for certain which accounts will fund the $600 million transfer, the impact of this decision on implementation of the GHSA is also uncertain.If funds are transferred from CDC accounts, GHSA efforts could be delayed or stalled. It also remains to be seen whether the Administration will receive additional funding to supplement the Zika response. While Congress has not acted on a request for a stand-alone supplemental funding, members have suggested they are open to providing additional funding in the future should the reallocation of existing funds prove insufficient to both addressing Zika and completing the Ebola response. The possibility remains that we could see additional funding for Zika as part of the regular appropriations process, which is likely to progress in the coming months.