Good Day BIO: Let’s talk about animal biotech

Before you head out for the long weekend, we have BIO’s new letter on animal biotech and a look at the work to be done to eradicate polio and rubella. (778 words, 3 minutes, 53 seconds)

We’ll be off on Monday, February 21, for Presidents’ Day. We’ll resume publication on Tuesday, February 22.

Let’s talk about animal biotech rules

BIO sent a letter Wednesday to the Office of Management and Budget (OMB) urging the Biden administration to “take specific and immediate steps” towards modernizing oversight of animal biotech and allowing stakeholders to comment.

The context: Animal biotech like gene editing can improve the disease resistance, animal welfare, and environmental impact of food animals—but just two biotech animals have been approved for food. 

This is why we need guidance. OMB should allow “the Food and Drug Administration (FDA) to promptly publish a draft guidance document for stakeholder notice and comment on proposed changes to FDA’s regulatory framework for animal biotechnology,” says BIO's letter, giving all stakeholders the chance to “review, analyze, and comment.”  

An effective regulatory framework should be based on four principles, BIO says:

1. Oversight must protect animal health and welfare, ensure the safety of food and feed derived from the animals, and consider the possible impacts of the animals on the environment.
2. Implementation of oversight must be clear, transparent, efficient, predictable, timely, and based upon the best available science.
3. Risk assessment must be proportionate to the actual risk posed by the specific species/trait combination. Lower-risk, more-familiar traits, including traits that impart health benefits to humans and animals, should be given a more expedited review than traits for which there is less familiarity or greater uncertainty.
4. Once all appropriate safety reviews are completed, the approved animals should be allowed to be treated as any other farm animal in production and commerce. Ongoing post-market regulatory requirements imposed on such animals, even after they have been determined to be as safe as conventional animals, strongly disincentivizes development and commercialization of farm animals with improved traits.

USDA has indicated openness to revisiting regulations on gene-edited animals,as we’ve reported. As BIO noted a year ago and Wednesday, meaningful change also requires changes to FDA’s regulations, which were not fully open to comment.

We could eliminate polio and rubella—with vaccination campaigns

It’s possible to eradicate polio and rubella—thanks to vaccines. But a new outbreak of polio in Malawi 18 months after Africa was declared polio-free highlights the importance of continuing routine vaccination campaigns, even during a pandemic.

The single polio case in Malawi,reported yesterday, did not undo Africa’s “poliovirus-free” certification, as the strain is apparently imported from Pakistan, the WHO says. 

But it’s troubling: “Unless we eradicate polio, within 10 years, as many as 200,000 new cases could occur around the world each year,” says End Polio. 

The polio vaccine, invented in 1955, has nearly eradicated the virus, with Pakistan and Afghanistan being the last two countries in the world where polio is still endemic.

Similarly, with the rubella containing vaccine (RCV), “eradication of the rubella virus is possible, indeed more feasible than eradication of measles or mumps,” says The Journal of Infectious Diseases. 

Between 2012 and 2020, “global RCV coverage has increased by 30%, and one region (the Americas) has eliminated rubella,” says a new report from the CDC. But 11% of countries still have not introduced the vaccine. 

The CDC and WHO work with the Measles & Rubella Initiative to increase distribution of combined rubella-measles vaccines, which cost about $2 per child and reduced measles deaths by 62% between 2001 and 2021.

More Health Care News: 

WHO: WHO announces first technology recipients of mRNA vaccine hub in Africa
Egypt, Kenya, Nigeria, Senegal, South Africa, and Tunisia will be the first countries to “receive the technology needed to produce mRNA vaccines on the African continent," WHO Director-General Dr. Tedros Adhanom Ghebreyesus announced. "Primarily set up to address the COVID-19 emergency, the hub has the potential to expand manufacturing capacity for other products as well, putting countries in the driver’s seat when it comes to the kinds of vaccines and other products they need.”

Register Now: Sepsis Alliance Leadership Conference
On April 6, the free and virtual Sepsis Alliance Leadership Conference: Empowering Improvements in Care will bring together sepsis care leaders to discuss the role healthcare executives and leadership can play in improving awareness, recognition, diagnosis, and treatment of sepsis. Learn more and register at SepsisLeadership.org.

President Biden’s Friday: A phone conversation with trans-Atlantic allies over the growing threat of a Russian invasion of Ukraine is scheduled for this afternoon, Washington Post reports. 

What’s Happening on Capitol Hill: Enjoy the long weekend.