Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.
COVID BARDA bucks on the table
As the effectiveness of current vaccines and therapeutics against currently circulating COVID strains in the U.S. wanes, so too is public interest in receiving them. And with that declining interest has come an inevitable dent in the financial landscape for pandemic products.
Pandemic superstar Pfizer, for example, which saw its 2022 earnings hit a record high of $100 billion, has narrowed its forecast for 2023 down to $67-70 billion as it grapples with loss of sales from its COVID portfolio.
While existing vaccines and therapeutics against COVID are still effective at preventing serious illness and death, they are less capable of reducing infection and transmission over time. And since it’s safe to assume that COVID is sticking around and will keep evolving, continued investment in the space is necessary.
To that end, the U.S. government announced the ‘Project NextGen’ initiative back in May, with a goal to accelerate and streamline the rapid development of the next generation of vaccines and therapeutics. The $5 billion HHS initiative, led by BARDA, leverages public-private partnerships to develop new vaccines and therapeutics to better address current viral strains and prepare for future ones.
In August, the initiative handed out $1.4 billion in funding, which included $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody, and $100 million to explore novel vaccine and therapeutic technologies
This week, we reported that Gritstone bio was awarded a $433 million BARDA contract to conduct a comparative study evaluating the company's self-amplifying mRNA vaccine candidate against an approved COVID-19 vaccine.
BARDA says partnership opportunities are still available. It's good news for future COVID vaccines, and more broadly, an essential effort to better prepare our country for the next pandemic
—Karen Langhauser
BrainStorm’s ALS hopeful fails to impress AdComm
In a video uploaded to her personal Youtube channel, Brooke Eby, a 34-year-old ALS patient, pleaded in her statement to the FDA. “With NurOwn, I’d be given the chance at a future. The opportunity to approve NurOwn as a treatment option would provide hope to the entire community.”
It was stories like Brooke’s that left so many of the FDA AdComm members feeling conflicted about turning down BrainStorm’s ALS stem cell hopeful this week. In a 17-1 vote, members stressed that while patient stories and physicians’ statements were compelling, data for NurOwn, a mesenchymal stem cell therapy, failed to impress.
Although there is no cure the debilitating and fatal neurological disorder, the FDA has approved other treatments to help manage symptoms. At the core of their hesitancy, AdComm members stressed, was BrainStorm’s data and their inability to demonstrate how they would safely manufacture the treatment.
What I found interesting from hearing members' statements is that many of them expressed how there are several aspects of bringing MSC therapies to patients that have yet to be ironed out. While the agency has designed frameworks for stem cell trials, the road to approval hasn’t been fully cleared in the U.S.
Although MSCs show promise in treating diseases, there are still manufacturing issues keeping them from shining. As of April 2023, there were 1,120 clinical trials worldwide for MSC therapies, but only 12 of them got the green light for commercial use. Nine of the approved products are from Asia, with South Korea leading the way.
While the AdComm's decision dashed hopes for an early approval of MSC therapy for ALS patients, it prompted regulators to have discussions about the remaining knowledge they need to gather before granting the first one. In that light, it could still be a win.
— Andrea Corona
