WASHINGTON, D.C. — The Biomedical Advanced Research and Development Authority (BARDA) has announced up to $500 million in funding under Project NextGen to advance clinical trials of novel COVID-19 vaccines delivered as a nasal spray or oral pill. This initiative aims to enhance vaccine accessibility and efficacy through innovative delivery methods.
HHS Secretary Xavier Becerra highlighted the importance of this effort, stating, “We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness.”
The funding, administered by BARDA’s Rapid Response Partnership Vehicle, supports three companies in preparing their vaccine candidates for Phase 2b clinical trials:
- Vaxart of San Francisco, California: Up to $453 million will be allocated for developing an oral pill vaccine candidate, adenovirus serotype 5 (Ad-5). BARDA will initially provide $65.7 million for early trial milestones, with additional funds as the project progresses. Vaxart will execute its own Phase 2b clinical trials.
- Castlevax, part of the Mount Sinai Health System in New York City: Approximately $34 million will support development of an intranasal vaccine candidate, CVAX-01.
- Cyanvac of Athens, Georgia: Approximately $40 million will fund development of another intranasal vaccine candidate, CVXGA.
Castlevax and Cyanvac will conduct their Phase 2b trials in partnership with BARDA’s Clinical Studies Network.
Assistant Secretary for Preparedness and Response Dawn O’Connell emphasized the potential of these next-generation vaccines. “At ASPR, we are working to unlock technology that will better protect Americans from viruses like COVID-19,” O’Connell said. “The next generation vaccines that BARDA is investing in may bolster our protection against COVID-19 and be easier to administer through intranasal or oral delivery.”
Enhancing COVID-19 Protection
Current COVID-19 vaccines, administered via intramuscular injection, have proven highly effective. However, they are limited in inducing strong immune responses in mucosal areas such as the mouth, nose, and gut, where the virus first enters the body. Intranasal and oral vaccines could address this gap by providing more robust mucosal immunity, potentially offering superior protection at the virus’s entry points.
Furthermore, needle-free vaccines present significant advantages in terms of ease of administration and accessibility. They eliminate the need for trained medical personnel to administer shots, reduce needle-related anxiety, and facilitate mass vaccination campaigns, especially in resource-limited settings.
Implications for Public Health
The successful development of these innovative vaccines could revolutionize how vaccinations are administered, not just for COVID-19 but for other infectious diseases as well. Easier-to-administer vaccines can lead to higher vaccination rates, essential for controlling outbreaks and achieving herd immunity.
Moreover, these new delivery methods could play a crucial role in future pandemic preparedness. Rapidly deployable vaccines that are easy to distribute and administer would be invaluable in responding to emerging infectious threats.
The Path Forward
Each of the three Phase 2b clinical trials will recruit 10,000 volunteers. Half will receive one of the investigational vaccines, while the other half will get an FDA-licensed vaccine. These trials aim to compare the efficacy and safety of the new vaccines against existing ones.
BARDA’s significant investment underscores the commitment to advancing public health through innovation. By supporting these promising vaccine candidates, the U.S. aims to strengthen its defenses against COVID-19 and improve overall pandemic resilience.
In summary, BARDA’s $500 million funding for innovative COVID-19 vaccine trials represents a pivotal step in enhancing vaccine technology and accessibility. The development of nasal spray and oral pill vaccines could transform public health strategies, offering safer, more effective, and user-friendly options to protect against COVID-19 and future pathogens.
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