Good Day BIO: FDA's decision on gene-edited cattle for food

Happy International Women’s Day. Today, we look at FDA’s decision on gene-edited cattle for food and CEPI’s economic case for pandemic preparedness. (773 words, 3 minutes, 51 seconds)

FDA greenlights marketing gene-edited cattle for food

The FDA’s first-ever low-risk determination for a food animal is a win for animal welfare, climate resilience, and science.

The FDA made its first “low-risk determination” for two genome-edited beef cattle and their offspring, “determining that the intentional genomic alteration (IGA) does not raise any safety concerns,” says the announcement. 

What’s the deal with these cows? The genome is edited to have a “short-hair coat trait seen in some conventionally bred cattle, known as a ‘slick’ coat,” explains the FDA. They’re more tolerant to heat and can therefore function more efficiently, as this 2018 WSJ documentary explained—meaning the decision helps livestock adapt to climate change and helps farmers sustainably increase animal protein production for a growing world. 

What happens now? The developer (BIO member Acceligen) does not need to pursue FDA approval prior to marketing, which is a win for science.

What they’re saying: “Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals,” said Steven M. Solomon, D.V.M., M.P.H., Director of FDA’s Center for Veterinary Medicine. “It also demonstrates our ability to identify low-risk IGAs that don’t raise concerns about safety, when used for food production.”

Why it matters: “We expect that our decision will encourage other developers to bring animal biotechnology products forward for the FDA’s risk determination in this rapidly developing field, paving the way for animals containing low-risk IGAs to more efficiently reach the marketplace,” continued Solomon.

The FDA decision comes on the heels of a similar decision in Brazil, which said these kind of gene-edited cows do not fit the definition of a “GMO,” allowing them to be imported into the country—here’s the announcement (in Portuguese).

Can we make the next vaccine in 100 days?

Yes—if we invest now in pandemic preparedness, says the Coalition for Epidemic Preparedness (CEPI), which is holding a pandemic preparedness summit in London with global stakeholders (including BIO) to discuss how we make it happen.

CEPI’s seeking to raise $3.5 billion to implement the 5-year pandemic plan—small potatoes compared to the $28 TRILLION the pandemic is expected to cost the economy by 2025.

This investment will help compress the vaccine development timeline to 100 days—and develop preparedness initiatives like vaccines that provide broad protection against coronaviruses and a library of prototype vaccine candidates, says CEPI’s investment case.

BIO looks forward to “collaborating with CEPI in their effort to fully replenish funds,” said BIO President and CEO Dr. Michelle McMurry-Heath in a joint industry statement with the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

The global biotech industry has made a number of commitments, including investing in R&D on target pathogens with pandemic potential and building a “portfolio of promising candidate vaccines, treatments, and technologies,” among others—read the entire statement.

Dr. Michelle’s Diagnosis: We've witnessed firsthand over the last two years the power of strong collaboration between academia, small and large biotech companies, regulatory officials, and manufacturing sectors—all in record time. Supporting partners like CEPI, along with other NGOs, are crucial to ensuring rapid and equitable access to vaccines on every corner of the globe. – BIO President and CEO Dr. Michelle McMurry-Heath

CEPI’s Global Pandemic Preparedness Summit is happening now—click here to watch. 

More Health Care News:

RealClearHealth (Opinion): In PDUFA VII, the opportunity to strengthen FDA’s pandemic preparedness is now
“The reauthorization of PDUFA is considered ‘must-pass’ legislation and offers a vehicle for Congress to apply important COVID-19 lessons to ensure the U.S. has a robust and effective response for the pandemics of the future, as well as to strengthen FDA for patient benefit overall,” says Shawn O’Neail, VP of Global Affairs at Eli Lilly. 

The San Jose Mercury News (Opinion): Don’t sacrifice the miracle of American innovation
“Protecting innovation isn’t a partisan issue. The Biden administration can prevent a catastrophic drop in private-sector research and development investment by rejecting this latest march-in petition,” writes Niels Reimers, founder and former Executive Director of Stanford University’s Office of Technology Licensing.

President Biden’s Tuesday: Heading to Ft. Worth, Texas, to speak alongside the Secretary of Veterans Affairs about addressing the health effects of environmental exposures such as burn pits.

What’s Happening on Capitol Hill: Work continues on legislation to fund the federal government ahead of the Friday deadline, while Senate committees will consider key Energy Department and State Department nominees. The House Agriculture Committee will hold a hearing on the 2022 Farm Bill’s rural development provisions with USDA Under Secretary for Rural Development Xochitl Torres Small, and the House Science Committee will hold a hearing on federal climate adaptation and resilience. Meanwhile, Rep. Frank Pallone (D-NJ) “moves to crack down on FDA accelerated approvals,” reports STAT News.