What's in the vaccine pipeline?

BIO’s report on the vaccine pipeline—just released today—explores the need for more investment and more research into novel pathogens. Meanwhile, USDA has proposed regulatory changes to genetically engineered crops, but BIO explains why they’re too complicated. (514 words, 2 minutes, 34 seconds)

BIO report explains what’s in the vaccine pipeline – and what’s not

Vaccines have changed the course of human history—but the current clinical pipeline needs more shots on goal and requires more capital, explains a BIO report released today.

By the numbers: The current pipeline has 249 active novel clinical-stage programs addressing 31 infectious diseases for which there is no approved vaccine, says BIO’s report, The State of Innovation in Vaccines and Prophylactic Antibodies for Infectious Diseases.

“The pipeline is relatively deep for COVID, and it’s really shallow for most everything else,”says David Thomas, SVP of Industry Research and Analysis at BIO and one of the report’s authors. Only 10% of infectious disease threats are addressed by 10 or more programs, and nearly 30% of candidates target COVID-19. 

Why it matters: “Vaccines have led to a 100% reduction in the risk of death for a host of devastating diseases,” says Phyllis Arthur, BIO SVP, Infectious Diseases & Emerging Science Policy. “Yet many common infections don’t have any vaccines in clinical development. That needs to change.”

Only 3.4% of biopharma venture capital—$6.5 billion—went to companies with infectious disease programs in the last decade. By comparison, oncology drug development received $72.6 billion, or 38% of the VC.

BIO recommends:

1. Capitalizing on platform technologies, with better use of data and AI.
2. Expanding vaccine access.
3. Rebuilding vaccine confidence.
4. Revising the review process to “adapt to the changing vaccine landscape and create a predictable review environment.”

The bottom line: “We’ve seen incredible progress recently in areas like RSV and HPV, but unless there is more dedicated, persistent investment toward new vaccines, we’ll fall behind,” says Thomas.

Read more about the report and what the experts say on Bio.News.

USDA proposal for genetically engineered plants too complex, BIO says

USDA’s proposed regulatory exemptions for five genetic modifications achievable through conventional breeding are “a positive step,” but the rules can be simplified, says BIO in comments last week. 

What happened: The USDA Animal and Plant Health Inspection Service (APHIS) has proposed exemptions to its rules for “Organisms Modified or Produced through Genetic Engineering.” BIO provided detailed technical input in a joint letter with the American Seed Trade Association (ASTA) and another letter from 60 agricultural organizations.

Why it matters: Reducing unnecessary regulatory barriers to biotechnology innovation for plants is essential to addressing climate change and ensuring global food security.

The proposed rules for exemptions are too complex, posing potential barriers to market entry, both letters say.

An unnecessary distinction: APHIS proposes different exemptions for alloploids, which have chromosomes from more than one species, and autoploids, with chromosomes from a single species. This distinction is not supported by science and is not made by other regulatory regimes, the letters say.

BIO’s view: The “increased complexity in the currently proposed exemptions” poses an unneeded obstacle, says the BIO-ASTA letter. APHIS should use “a more streamlined, plain language set of exemption criteria, consistent with the approach taken in several other global jurisdictions.”

President Biden’s Thursday: Delivering remarks on “Investing in America and the Bipartisan Infrastructure Law,” in Superior, Minnesota, per Wisconsin Public Radio.

What’s Happening on Capitol Hill: Quiet Thursday.