Good Day BIO: A monkeypox vaccine – and a new COVID vaccine?

Today, we have an exclusive look at how the industry is responding to monkeypox—thanks in large part to sustained investment in medical preparedness. Plus, an FDA advisory committee recommends emergency use authorization of the Novavax COVID-19 vaccine—so what’s next? (821 words, 4 minutes, 6 seconds)

The bad news: monkeypox. The good news: we’re already prepared.

And it’s thanks to sustained investments in medical countermeasures and partnerships between the federal government and biotech companies, as Joel Straus, BIO’s Manager of Healthcare and Infectious Disease Policy, exclusively told Bio.News.

The U.S. has stockpiled monkeypox vaccines—BIO member Bavarian Nordic’s smallpox vaccine Jynneos, approved in 2019, which is 85% effective at preventing monkeypox, and ACAM2000, which provides protection against orthopoxviruses (including monkeypox). Both vaccines are included in the Strategic National Stockpile (SNS).

This is possible thanks to investment in medical preparedness. Bavarian Nordic has partnered with the federal government since 2003 to develop “a non-replicating smallpox vaccine to ensure all populations can be protected from smallpox, including people with weakened immune systems.” 

This is a success story for BARDA—the U.S. Biomedical Advanced Research and Development Authority, which has provided more than $500 million to Bavarian Nordic over the past decade, explains Bio.News.

What they’re saying: “Decades of investments and collaborations into advanced R&D against smallpox have had a positive dual effect: they have led to the development of multiple vaccines and treatments that are effective not only against smallpox, but also against other orthopoxviruses, including monkeypox,” wrote CEPI CEO Dr. Richard Hatchett.

“It’s an example of how past investments are making it possible to respond to a viral threat today,”continued BIO's Straus. “Because the federal government took smallpox seriously and maintained their investment in preparedness, we’re able to rapidly respond to orthopox threats either from a deliberate smallpox attack or a naturally occurring outbreak like monkeypox today.”

The context: Funding for these kind of public-private partnership programs has “remained largely stagnant over the past decade,” Phyllis Arthur, BIO’s VP of Infectious Diseases and Emerging Science, testified last year. BIO calls for budget increases for BARDA and SNS, and supports the pandemic preparedness investment outlined in President Biden’s FY2023 budget request. BIO urges lawmakers to bring BARDA and the SNS funding up to the levels requested by the professional judgment of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Multi-Year Budget. 

The big picture: Monkeypox will not be the last global health threat, and the U.S. government must support the advanced R&D and stockpiling required to respond quickly to the next future threat. 

Get the story at Bio.News.

FDA advisory committee recommends Novavax vaccine

The COVID-19 vaccine developed by BIO member Novavax is moving forward—here’s the story.

The news: The FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 (with one abstention) to recommend the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine for individuals 18+.

The vaccine: NVX-CoV2373 demonstrated 90.4% efficacy with “serious and severe adverse events were low in number and balanced between vaccine and placebo groups,” says Novavax. It’s already authorized for use by more than 40 countries and the World Health Organization.

Read: Inside Novavax, the Maryland biotech with a promising COVID vaccine

Why it matters: “We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Novavax President and CEO Stanley C. Erck said earlier this year.

In other words: “Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccines,” Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research (CBER), told POLITICO.

The next steps: While the FDA is not required to follow the advisory committee’s recommendation, it usually does—and that could happen as soon as this week. In the meantime, Novavax says they have already submitted an amendment with updated manufacturing information for review. 

Learn More: John Trizzino, MBA, SVP, Chief Business Officer, and Chief Financial Officer of Novavax, will be speaking at the BIO International Convention next week about lessons learned during the development of COVID vaccines—get the details and register now.

More Health Care News:

Moderna: First participants dosed in phase 3 study of mRNA seasonal influenza vaccine
“We believe our mRNA platform, with the flexibility and speed of our manufacturing process, is well-positioned to address the significant unmet need in seasonal flu,” said Moderna CEO Stéphane Bancel. 

The San Diego Union-Tribune (Opinion): Here’s how San Diego biotech helped fight the COVID-19 pandemic
“Countless academic and research institutions, companies and organizations working on life sciences and biotechnology are woven into the city’s fabric,” write BIO’s Dr. Michelle McMurry-Heath, Biocom California’s Joe Panetta, and California Life Sciences’ Mike Guerra.

President Biden’s Wednesday: Heading to Los Angeles, where he’ll appear on Jimmy Kimmel Live! tonight, his first in-studio appearance as POTUS on a late-night talk show. He’ll then kick off the ninth Summit of the Americas, though it’s already a little contentious, as CNN reports. 

What’s Happening on Capitol Hill: Yesterday’s House vote on the FDA user fee legislation was pushed to today; we’ll keep an eye on it and report back tomorrow. Meanwhile, the Senate Health, Education, Labor, and Pensions (HELP) Committee is marking up their version of the FDA user fee reauthorization legislation.