Good Day BIO: U.K. approves world’s first COVID-19 pill

Starting the week in Europe, with the U.K. approval of the Merck-Ridgeback COVID-19 pill and ongoing climate discussions. Meanwhile, an International Council of Biotechnology Associations (ICBA) delegation (including BIO) is in Geneva to discuss how the industry is leveraging global partnerships to produce billions of vaccines by mid-2022 and share new technologies with the globe—more on that to come. (605 words, 3 minutes, 1 second)

U.K. approves world’s first COVID-19 pill

The U.K. is the first country in the world to approve use of the new antiviral drug molnupiravir developed by Merck and Ridgeback Biotherapeutics.

“Molnupiravir has been authorized for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness,” U.K. regulator Medicines and Healthcare products Regulatory Agency (MHRA) said Thursday. 

The drug was shown to halve the risk of hospitalization or death in recent studies. U.K. rollout begins later this month, with the pill to be given “as soon as possible following a positive COVID-19 test and within five days of symptoms onset,” MHRA said.

How does it work? “The virus essentially mutates itself to death,” Richard Plemper, a virologist involved in developing molnupiravir, told Nature. The drug mimics the RNA by which the coronavirus reproduces, introducing mutations that kill the viral population. 

The U.S. could be next. The Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee will discuss emergency use authorization at a November 31 meeting. 

The development is “extremely important”—but vaccines are still the best defense, according to Dr. Anthony Fauci. (So, get vaccinated if you haven’t already!) 

It’s also an example of the importance of America’s pharmaceutical innovation ecosystem—and The Bayh-Dole Act, which helped bring the discovery from science in the lab at Emory University, to further development and clinical trials thanks to the partnership between Merck and Ridgeback, as we explained.   

Meanwhile, another antiviral could be coming soon. Pfizer announced Friday that their antiviral pill, PAXLOVID, showed 89% efficiency in preventing hospitalization and death. Pfizer will request emergency use authorization with the FDA soon.

How biotech can reduce the footprint of health care, fuels, and more

International leaders (including BIO’s Dr. Michelle McMurry-Heath) discussed eliminating carbon emissions from the health care supply chain when the International Leadership Group for a Net Zero NHS gathered Friday, alongside the UN Climate Summit.

Recognizing health care delivery contributes 4.4% of global carbon emissions, the U.K. National Health Service (NHS) took the lead in committing to cutting carbon emissions to zero. The effort requires participation from NHS suppliers; many suppliers’ CEOs joined Friday’s meeting. 

BIO President & CEO Dr. Michelle McMurry-Heath represented BIO’s position that biotechnology has a major role to play in reducing carbon emissions.  

The commitment adds to progress achieved so far during COP26 in Glasgow. Already, 40+ countries pledged to move away from coal—a commitment that will require use and deployment of sustainable biofuels. 

BIO’s involvement in COP26 includes joining the Agriculture Innovation Mission for Climate (AIM),a voluntary effort launched by the United States and the United Arab Emirates with 31 countries. BIO is one of nearly 50 non-governmental Knowledge Partners. 

Biotech solutions will be showcased during another COP26-parallel event, the Sustainable Innovation Forum. BIO member Amyris, which makes sustainable personal care products and sanitizers using synbio, will present at the forum. 

Amyris will highlight “the vast potential of synthetic biology to build a more sustainable future. Biology is the most effective manufacturing model for making essential products more sustainable, economical, and higher performing”—without petroleum. 

President Biden’s Monday: At 1 PM ET, a White House press briefing will feature Transportation Secretary Pete Buttigieg, who can be expected to discuss details of the infrastructure bill passed Friday. In the afternoon, President Biden will welcome 2021 NBA Champions The Milwaukee Bucks.

What’s Happening on Capitol Hill: Officially in recess. “The day after the fragile passage of President Biden's infrastructure bill, House leaders were already working on Part Deux,” Axios' Mike Allen said yesterday. “Democrats hope to pass the bigger social-safety-net bill two weeks from now—the week before Thanksgiving.”