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Moderna’s Avian Influenza Vaccine Development Program An increase of $176 million The announcement was made by the US government earlier this month.
Gary Disbrow, Director, BARDA
Permitted by BARDA
The number of H5N1 avian influenza cases Grant funding to support the new mRNA-based vaccines, which are ramping up very slowly, came from the HHS Biomedical Advanced Research and Development Authority. Spread among cattle It has been found in cattle and poultry across the United States, and its recent jump to humans has the scientific community in stitches, but the surprising jump from cattle to humans isn’t the reason BARDA awarded the grant to Moderna.
“Many people think we’re doing this in response to H5N1,” BARDA Director Gary Disbrow said, “but this is an effort that began in October 2023.”
This financial support is part of BARDA’s continuing mission to partner with the private sector to develop medical countermeasures to public health medical emergencies.
“The mission given to us by Congress is to support the advanced research and development and innovation, FDA licensure, and procurement of products that address threats to national security,” Disbrow said.
Since its launch 15 years ago, that mission has placed BARDA on the front lines of major public health crises in the United States. HistoryTo date, BARDA has achieved many things, including 61 FDA approvals, two Ebola vaccines and treatments, and about $1.6 billion in investments in products to combat antimicrobial resistance. BARDA gets a lot of press when big-name companies win awards for diseases like avian flu that are already in the news, but its mission goes beyond that. Part of Disbrow’s job is to get the word out to potential industry partners.
“A lot of people don’t understand what BARDA is or how to work with them. BARDA has multiple avenues for funding companies, ranging from early-stage companies to mid-size companies to large companies,” Disbrow said. “Most outside companies don’t know how to get in or how to make that first contact with the federal government.”
“People always say you only use one drug for one pathogen, but that’s a very expensive proposition. What we’re trying to build is a rapid response capacity.”
Gary Disbrow
Director, BARDA
BARDA is seeking to improve preparedness against H5 influenza viruses, including the H5N1 strains causing current outbreaks in livestock, with its latest grant to Moderna Inc. The grant will support the development of an mRNA-based seasonal and pandemic influenza vaccine.
It’s also an example of how BARDA supports platform technologies that can be adapted to different strains of the disease. “As part of the preparedness organization, we were very interested in leveraging the success of mRNA vaccines and moving that forward and potentially having it as another option alongside egg-based, cell-based and recombinant-based technologies,” Disbrow said.
While Moderna’s award is big news, most of BARDA’s grants are much smaller. The agency partners with companies of all sizes in a variety of ways, including: Blue Knight The program is a joint collaboration between BARDA and J&J’s life sciences incubator, JLABS, and is designed to support startup companies focused on public health threats and emerging infectious diseases.
“We’ve supported 46 companies to date,” Disbrow said, “and because the government de-risked the early stages of product development, (these companies) received more than $933 million in additional investment from private equity, and several of those have gone on to become commercial products.”
Other opportunities include BARDA Ventures but also Biopharmaceutical Manufacturing Preparation Consortium He is also interested in countering anthrax, botulism, radiation poisoning and other emerging threats.
The first step for companies that want to work with BARDA is to request a “TechWatch” meeting, which allows BARDA, along with HHS and other DoD agencies, to evaluate their technology.
“They can share commercially sensitive information with us and we provide them with honest feedback,” he said. “We have interagency colleagues there because if it’s not a perfect fit for BARDA, we want to make sure they have other places where they can potentially get funding.”
Here, Disbrow details how companies can work with BARDA and what it looks for in pharmaceutical companies.
This interview has been edited for clarity and style.
PHARMAVOICE: Besides funding, why would a company want to work with BARDA?
Gary Disbrow: Whether you are funded with less than $1 million or more than $100 million, we provide the scientific expertise, clinical expertise, non-clinical expertise, regulatory and manufacturing experts to partner with your company to maximize your chances of success.
Typically, it’s less than $1 million, but for companies with really interesting technology, that $1 million can support the research needed to apply for Series A funding to attract the attention of the private sector.
We’re not just providing non-dilutive capital. We’re forming partnerships. The U.S. government has access to technology, and we partner with these companies in the hope that we’ll gain capabilities that will increase our overall chances of success, and ultimately, products that will be developed and delivered to the American people as needed.
Interest in infectious diseases has increased during the COVID-19 outbreak. Is this area still interesting for companies or is it declining?
I think we’re seeing a decline on a number of fronts. The public is getting a little bit vaccine fatigued. Private equity investment is declining as people have seen the global COVID-19 market shrink. There’s just not as much demand as we would like for vaccinations to continue.
But that’s why… we were founded with $5 billion in backing. Project NextGenand that’s to partner with NIH. They’re partnering with us to support the development of the next generation of COVID vaccines and therapeutics and what we call enabler technologies. This is not Operation Warp Speed. We don’t have enough money to run a program from start to finish and get the USG (United States Government) to buy it. But some of the most expensive and risky ventures for these companies are the clinical trials. So the US Government will de-risk those clinical trials.
What else does BARDA want from the pharmaceutical industry?
People always say just use one medicine for one bug, but that’s a very expensive proposition.
What we’re trying to build is a rapid response capability to not only be prepared but to be able to respond quickly to any threat that emerges. And we’re going to invest in technologies and platforms. I know people use “platforms” in different ways. They’re vaccine technologies, they’re new technologies for manufacturing therapeutics that we can leverage to respond very quickly to emerging threats.
Again, the quickest response is possible when FDA-approved products are available. We learned that with Ebola. Mupox And other emerging infectious diseases that we have had to face. Without them, we would not have had time to do basic research and development in the traditional way (for example). Ebola VaccineThis is the first licensed vaccine and platform that we’ve supported in collaboration with Merck, with government ministries, and with our partners around the world. It’s a viral vector that expresses the Ebola Zaire glycoprotein. By taking the Marburg and Ebola Sudan glycoproteins and putting that glycoprotein in place of the Zaire glycoprotein, we hope to develop a Marburg or Sudan vaccine.
This vaccine technology can serve as a platform: the vaccine has a well-known safety profile, has been administered to hundreds of thousands of people worldwide, and the manufacturing process is controlled, so we hope to be able to leverage the already established manufacturing safety when replacing glycoproteins.
