FDA approves updated COVID vaccines

The FDA approved updated COVID vaccines as COVID is surging, and we’re marking the one-year anniversary of Biden’s biomanufacturing executive order with a look at what more needs to be done. (566 words, 2 minutes, 49 seconds)

FDA approves updated COVID vaccines from Moderna and Pfizer-BioNTech

Yesterday’s Food and Drug Administration (FDA) approval of the updated Moderna and Pfizer-BioNTech mRNA vaccines will enhance protection as COVID-19 surges.

The news: The Pfizer-BioNTech and Moderna vaccines are approved for people over 12 and authorized for emergency use for children ages 6-11, FDA said. Two doses are no longer needed; this new approval covers single doses.

Why it matters: COVID-19 infections are increasing worldwide, with U.S. hospitalizations up 8.7% and deaths up 2.1% week-on-week from Aug. 27-Sept. 2, said the Centers for Disease Control and Prevention (CDC). Up-to-date vaccination offers the best protection against COVID-19.

What’s different: The new vaccines are designed to target the Omicron XBB.1.5 mutation of the virus, per the request in January from FDA’s Vaccines and Related Biological Products Advisory Committee.

The effectiveness: Both shots proved effective against the now-dominant EG.5 (Eris) variant and newer BA.2.86 (Pirola) variant—“another example of what our mRNA platform can accomplish with incredible speed, scale and flexibility,” said Moderna CEO Stéphane Bancel.

Another shot: Novavax’s updated vaccine, made with protein-based technology, awaits FDA approval, which is anticipated soon.

What happens next: CDC’s Advisory Committee on Immunization Practices will meet today (Tuesday) and is expected to recommend use of the new vaccines. Moderna and Pfizer said they are ready to ship their vaccines to pharmacies, doctors, and hospitals pending CDC recommendation.

More Health News: 

The Wall Street Journal: Generic drugs should be cheap, but insurers are charging thousands of dollars for them
“Across a selection of these so-called specialty generic drugs, Cigna and CVS’s prices were at least 24 times higher on average than roughly what the medicines’ manufacturers charge.”

Biomanufacturing EO, one year on

As we mark the first year of the Biden administration’s Executive Order on Biotechnology and Biomanufacturing today, BIO is eager to see the order put to work.

ICYMI: Biden’s Sept. 12, 2022, order seeks to promote biomanufacturing and the bioeconomy through coordinated federal research funding, streamlined regulation, data support, greater market opportunities, and training.

It’s a great initiative—but not enough has been done to implement it.

Specifically, BIO wants officials to:

• Enact tax credits for sustainable fuels. The administration said it would release Sustainable Aviation Fuel tax credit guidelines soon.
• Increase federal procurement of biobased products and educate federal procurement officers on the benefits of the BioPreferred program.
• Develop North American Industry Classification System codes to facilitate the BioPreferred program.
• Streamline regulation of climate-positive tech. Policymakers must prioritize clarity and efficiency in regulating biotechnology and demonstrate an understanding of biotechnology’s potential to provide solutions for priority issues, like addressing climate change.
• EPA should revise its Plant Incorporated Protectants (PIPs) rule. Issued in May, the current rule provides only a narrow exemption for PIPs and treats PIPs produced through biotechnology differently from those made with traditional plant breeding.
• Modernize regulation of gene-edited animals. FDA’s proposed regulation is delayed as the U.S. Department of Agriculture argues it should take the regulatory lead.
• Streamline applications for biobased manufacturing support through the USDA Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program.

Why it matters: Biomanufacturing can address climate change and other environmental challenges while boosting the economy with high-paying jobs. We need to realize the potential offered by Biden’s biomanufacturing executive order.

President Biden’s Tuesday: No official events.

What’s Happening on Capitol Hill: The clock is ticking on a host of legislation stalled by a budget battle that could drag on past the Sept. 30 deadline. We’ll be watching legislation targeting pharmacy benefit managers (PBMs), with Democrats’ support building for a House proposal to bring transparency to PBMs. Today, the Senate Homeland Security and Governmental Affairs Committee holds a hearing on understanding and mitigating threats to America’s supply chain security.