FDA panel backs GSK RSV vaccine – plus, what can we do about methane?

More RSV vaccine news today—plus, how regulatory changes could save horseshoe crabs, reduce methane emissions, and advance biotech innovation. (634 words, 3 minutes, 10 seconds)

FDA’s advisory panel backs GSK’s RSV vaccine

It’s the second advancement of RSV technology this week—with more expected soon. 

ICYMI: The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has been reviewing much-needed vaccines for respiratory syncytial virus (RSV) and recommended Pfizer’s vaccine for older adults on Tuesday.

Yesterday, the committee backed GSK’s vaccine—voting to recommend the vaccine for older adults. The FDA is expected to decide on approval by May 3.

What they’re saying: “Today’s vote brings us an important step closer to delivering one of the world’s first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems. Thousands of older adults in the US are impacted by RSV and those with underlying health conditions, like respiratory and heart diseases and diabetes, are at increased risk of severe complications,” said Phil Dormitzer, Global Head of Vaccines R&D at GSK.

More reading: 2023 is shaping up to be the year of RSV—in a good way

A rule change could spare horseshoe crabs and advance drug innovation

After surviving five mass extinctions, horseshoe crab populations are under pressure—but a regulatory change allowing drug makers to use a synthetic alternative to crabs’ blue blood could help.

The problem: Horseshoe crab blood provides limulus amebocyte lysate, used in millions of tests annually to screen injectable drugs for dangerous endotoxins, writes author Deborah Cramer in The New York Times. But horseshoe crab populations are dwindling.

The solution: A cloned alternative, rFC, has been available since 2003, but the quality assurance organization U.S. Pharmacopeia (U.S.P.) has yet to issue standards for its use. 

Now, progress is happening: U.S.P. convened an expert committee that met for the first time last month, says Cramer.

Biopharmaceutical companies are standing by. Driven by senior biologist and birder Jay Bolden, Eli Lilly is transitioning to rFC, as are fellow BIO members Sanofi, Pfizer, and Roche.

But without U.S.P. standards, they face “weeks of laboratory validation tests and documentation for every new product and subsequent F.D.A. regulatory review and approval,” Pfizer VP Ned Mozier tells Cramer.

With methane emissions up, policy change could help us fight back

Methane released by the energy sector last year nearly reached record levels—but policy change could help reduce emissions by the energy and the ag sectors.

The latest data: The International Energy Agency’s (IEA) latest methane tracker says the world energy sector—responsible for 40% of methane emissions—released a near-record 135 million metric tons last year.

We have technology to help—but we need policy to support it, says IEA. This policy should be pursued by the countries that signed the Global Methane Pledge at COP27 last year, adds IEA.

But in the U.S., agriculture contributes MORE methane than energy—due to things like cow belches and manure fermentation, according to the U.S. Environmental Protection Agency (EPA).

We have technology to help here, too—like biotech feed additives that can reduce methane emissions from cow belches by as much as 85%. (And Bill Gates is investing in it.)

But U.S. regulations treat animal feed additives as drugs, so these innovations must wait 3-5 years to hit the U.S. market.

We’re keeping an eye on it—FDA Commissioner Robert Califf and Agriculture Secretary Tom Vilsack say the policy should be reexamined, and the FDA is currently accepting comments (until March 9) on animal feed reviews.

President Biden’s Thursday: Joining the Senate Democrat’s Caucus lunch to tell Democrats to push back on Republican policies and build on their own work, per The Hill.

What’s Happening on Capitol Hill: House Oversight Committee Chair Rep. James Comer (R-Ky) yesterday announced an investigation of pharmacy benefit managers (PBMs), saying “Pharmacy Benefit Managers’ anticompetitive tactics are driving up health care costs for Americans and harming patient care. ... Greater transparency in the PBM industry is vital to determine the impact that their tactics are having on patients, the pharmaceutical market, and health care programs administered by the federal government.”