Looking to build on current RNA-based COVID-19 and influenza vaccines, the Biomedical Advanced Research and Development Authority (BARDA) recently announced the Patch Forward Prize, pledging $50 million for those who can advance patch-based vaccines.
While administering vaccines is most often done with a needle and syringe, BARDA’s director – Dr. Gary Disbrow – indicated this competition is meant to prove the time is right for more modern technology. Patches, in this case, refer to vaccine microneedle patches – or microarray patches – which shouldn’t trigger the fear of needles some people face. According to BARDA, they also could help reduce the need for syringes and vials that require complex cold chain storage and transportation, or the need for manufacturers to order vials, needles and syringes years in advance.
“This prize competition is a great representation of the many innovative partnership approaches BARDA is taking to transform vaccine development and strengthen the health security of our nation,” Dr. Robert Johnson, director of BARDA’s Medical Countermeasures Program, said. “By incentivizing a push forward for patch-based RNA vaccines into the clinic, this prize has the potential to offer a paradigm shift for vaccine administration and accessibility.”
Patch Forward will advance in stages. The first stage is the Concept Stage, during which entrants will submit concept papers detailing their respective technologies, proposed product, plans for development and functional testing. These are due by Oct. 3, 2024, after which they will be assessed by an expert judging panel and, ultimately, up to four will be recommended to receive a $2 million award from that stage’s $8 million prize pool.
Following this, a second stage will launch in early 2025, focused on those with preclinical study plans. In this Preclinical Stage, entrants will not need to have competed in the Concept Stage, but will need to submit technical papers detailing outcomes of their preclinical activities. In return, up to three winners could each receive a $7 million award.
Finally, in the Clinical Stage – which should launch in mid-2025 – RNA vaccine developers and patch makers who are planning to launch Phase I clinical trials for qualifying patch-based RNA vaccines will be invited to participate. These entrants will need to submit Investigational New Drug (IND) applications to the U.S. Food and Drug Administration for a clinical protocol that has not previously been filed with the FDA, and if chosen, up to two winners could each receive a $10.5 million Clinical Stage award.