‘Project NextGen’ to spend $1.4B in search for better COVID drugs, vaccines

2023-08-22

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The U.S. government will spend $1.4 billion across a series of contracts to develop new drugs and vaccines for COVID-19, the Department of Health and Human Services announced Tuesday.

The awards represent the first major announcement by “Project NextGen,” a federal program designed to spur newer therapies and protective shots against the coronavirus.

Announced in May, the program is a successor to the “Operation Warp Speed” initiative that helped bring the first COVID vaccines and drugs to market in record time.

Yet Project NextGen has been put together at a time when urgency around COVID has cooled and demand for existing treatments has slowed. Pfizer, for instance, has warned of cost cuts amid falling sales of the shot it developed with German biotech BioNTech. It and its rivals are also more focused on updating shots to match newer variants, rather than making more substantive changes such as a pan-coronavirus vaccines or intranasal shot.

The project is backed by $5 billion, far less than Operation Warp Speed eventually assembled, and doesn’t have the same wherewithal to make the bulk purchases that fueled the massive vaccine rollout in the first pandemic years.

Still, public health officials aim to develop new therapies, among them vaccines that can provide broader or longer-lasting protection, as well as antibody drugs more resilient to new viral variants.

COVID infections and hospitalizations are climbing in the U.S., according to recent data from the Centers for Disease Control and Prevention, a trend that’s expected to continue in the fall and winter. Newer versions of the virus called “Eris” and “Fornax” are now more prevalent.

“As the virus continues to evolve, we need new tools that keep pace with those changes,” said Assistant Secretary for Preparedness and Response Dawn O’Connell, in a statement. “Project NextGen combines the research and development expertise at HHS with the lessons we have learned about the virus throughout the pandemic — strengthening our preparedness for whatever comes next.”

In its announcement Tuesday, HHS said it awarded a $326 million contract to Regeneron Pharmaceuticals. The biotech was one of a few companies to successfully develop an antibody drug for COVID, medicines that helped protect people from some of the disease’s worst outcomes. Yet that success was short-lived, as new coronavirus variants evaded the protection of Regeneron’s drug as well as others like it.

The new contract will fund work on a newer antibody with “broad neutralizing activity” against the coronavirus, according to Regeneron. The biotech company will invent and propose a drug candidate and then work with the Biomedical Advanced Research and Development Authority to advance it. HHS will cover up to 70% of the development costs. The antibody will be designed for people who don’t respond to, or can’t take, the marketed vaccines, which HHS called a “critical need and current gap” in available care.

“Although COVID-19 has moved to an endemic stage, many people — including those with immunocompromising conditions — continue to face exposure that impacts their everyday life and could cause serious health consequences,” said CEO Leonard Schleifer, in a statement.

The bulk of the remaining funding, about $1 billion, is going to four clinical trial partners of BARDA: ICON Government and Public Health Solutions, Pharm-Olam, Technical Resources International and Rho Federal Systems. That money is meant to create a network of “at-the-ready trials” that can pivot to different vaccine candidates as they’re ready. The first trials could begin this winter, according to HHS.

The last of the funds were awarded to Global Health Investment and Johnson & Johnson to help back newer development and manufacturing methods. Additional awards are expected by the end of the year as well, HHS said.

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