Good Day BIO: FDA authorizes Novavax's COVID vaccine

The FDA has authorized the Novavax COVID-19 vaccine for emergency use, making it the fourth vaccine available in the U.S. We have the details, plus an exclusive interview with a Novavax executive. Plus, we take a look at how biotech is improving cosmetics and beauty products. (697 words, 3 minutes, 29 seconds)

FDA authorizes Novavax's COVID vaccine

The Food and Drug Administration (FDA) yesterday granted emergency use authorization to the Novavax COVID-19 vaccine for people over 18, making it the fourth coronavirus vaccine available in the United States.

Why it matters: Novavax’s vaccine can be stored in a standard vaccine refrigerator, and the protein-based vaccine is hoped to be more appealing to vaccine-hesitant people who have refused mRNA vaccines.

Ready for rollout: The Biden administration just announced an order of 3.2 million doses, which goes into effect with this authorization.

How well it works: In a phase 3 clinical trial conducted in 2020-2021, “the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19,” says FDA. Novavax says it has demonstrated broad cross-reactivity against Omicron and other circulating variants from a primary two-dose regimen, with responses that increased following a third dose at six months;” the company is testing the vaccine for use as an Omicron booster, as well.

Watch Good Day BIO Live: Novavax’s John Trizzino on when the company knew they had a vaccine that could work against COVID

What FDA says: “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality,” says FDA Commissioner Robert M. Califf. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so."

What Novavax says: “This authorization reflects the strength of our COVID-19 vaccine's efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues,” says Stanley C. Erck, President and CEO of Novavax, a BIO member company.

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

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With biotech, cosmetics get greener and cheaper

Biotechnology is helping cosmetics makers eschew animal- and fossil fuel-derived ingredients—making beauty products better for the environment and for consumers.

The demand logic: Consumers are paying more attention to the ecological footprint of their purchases, especially beauty and fashion, and increasingly prefer alternatives to conventional products.

The supply logic: Biotech alternatives to common cosmetic raw ingredients can be produced less expensively than animal products. Meanwhile, development time for a biotech-based cosmetic is shorter than development time for a medicine, Nature notes.

Here’s a great example: Squalene is a moisturizing agent traditionally sourced from the livers of sharks, including endangered species. But BIO member Amyris created a biotech alternative, by genetically engineering yeast and fermenting it with sugarcane to produce an exact replica. (And Reese Witherspoon loves it.)

Another biotech beauty breakthrough: a replacement for hyaluronic acid, a moisturizer and dermal filler typically extracted from roosters’ combs, Nature says. It’s made with microbial fermentation, too.

Biotech can replace fossil fuels in beauty, too—such as LanzaTech’s process to convert carbon emissions into ethanol. The product is being used to make packaging for L’Oreal and fragrances for Coty. L’Oreal’s also using a plant-based biotech version of the “long-lasting” ingredient isododecane in eyeshadows, produced in partnership with startup Global Bioenergies.

The bottom line: “It has to be cost competitive, it has to have the best performance, and it has to have the best sustainability profile,” Annie Tsong of Amyris tells Nature.

More Reading: Biotechnology can provide true clean beauty

President Biden’s Thursday: Meetings with the prime minister and other officials in Israel, as well as the first Leaders Meeting of the I2U2 group, with leaders of Israel, India, and the UAE. Iran and Ukraine are on the day's agenda, The New York Times reports.

What’s Happening on Capitol Hill: Senate Democrats are having trouble agreeing on a tax bill, which would be packaged with drug price controls, according to The Hill. The House Judiciary Committee will hold a hearing, “The Threat to Individual Freedoms in a Post-Roe World.”