Another RSV victory

“The Year of RSV” continues with FDA’s third RSV approval, and a new report highlights the economic value of California’s life sciences sector.

FDA approves first RSV vaccine to protect newborns

A vaccine given to pregnant mothers to protect infants from severe respiratory syncytial virus (RSV) was approved by the Food and Drug Administration (FDA) yesterday.

The vaccine: Pfizer’s Abrysvo is given to expectant mothers in weeks 32-36 to immunize infants from birth through 6 months. The first vaccine approved to protect infants from RSV comes in time for the autumn RSV season.

Why it matters: RSV is the leading cause of hospitalization of infants in the United States, with 58,000 under-fives hospitalized annually. It kills 100-300 babies a year and is especially dangerous during an infant’s first year.

RSV defenses grow: A new monoclonal antibody to protect infants was approved in July and recommended by the CDC in August. Pfizer’s Abrysvo in June received approval for use in adults over 60, a particularly vulnerable group. GSK’s Arexvy was approved for 60+ adults in May.

What they’re saying: “Today, a long-sought-after goal to deliver a maternal vaccine that will help protect infants six months of age or younger—when they are at greatest risk of possible serious consequences from RSV—has been achieved,” said Pfizer CSO Annaliesa Anderson.

What’s next: The CDC’s Advisory Committee on Immunization Practices, which determines whether FDA-approved vaccines should be recommended, has a regularly scheduled meeting for Oct. 25-27. Pfizer says it hopes for a recommendation that the vaccine be available to the public by October-November, before RSV season.

California’s life sciences sector is booming, finds report

The life sciences remains a major pillar of California’s economy, with the number of establishments in the sector growing 6% from 2021-2022—contributing to jobs, innovation, and overall economic output, says a new report.

A huge economic impact: The life sciences sector and its supply chain produced $472 billion in output for California’s economy, an increase of $61 billion over the previous year, says a new California Life Sciences (CLS) report.

A few more findings:

Jobs: California’s life sciences sector directly employed 335,231 people and indirectly supported 1,105,525 jobs in 2021. The average annual wage in the sector is $162,869.

Research funding: California life sciences brought in $5.5 billion in NIH funding, while VC investment increased more than 50% between 2019-2022, from $11.4 billion to $17.3 billion.

Innovations patented: This investment yielded 45.3 patents per 1,000 individuals in 2020—the highest rate in the country.

Talent pipeline: California universities produced 25,041 life sciences graduates, more than 10% of the national total. From 2017-2021, the increases in Hispanic and Black life sciences graduates in California were 59% and 33%, respectively.

But there’s a challenge ahead: The drug price controls in the Inflation Reduction Act are projected to lead to the loss of 127,337 jobs and over $38 billion in income in California between 2026-2035.

What the state is doing about it: The importance of biotech to California is reflected in the state legislature’s efforts to address 340B abuses negatively impacting drug manufacturers, and advance clean fuel standards, Bio.News reports.

Learn more live: CLS will hold a virtual town hall about the report on Wednesday—join here. 

More Agriculture & Environment News:

Reuters: Exclusive: Mexico says it won't modify decree on GM corn ahead of USMCA panel
“Mexico won't make any further changes to a decree on genetically modified (GM) corn ahead of a dispute settlement panel requested by the United States through the USMCA trade pact, Mexican economy minister, Raquel Buenrostro, told Reuters on Monday.”

President Biden’s Tuesday: Returning to Nevada for a vacation that was interrupted by a trip to view fire damage in Maui.

What’s Happening on Capitol Hill: The House and Senate are in recess through Labor Day.