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Fractional dosing troubles, a 'golden age' for rare kidney disease research, & Fauci makes it official

 

Morning Rounds

Good morning. A new STAT Report is launching today. 2022 Update: Ranking biotech's top venture capital firms is available here, and a story on OrbiMed's tumble from the top of the heap is here.

Fractional approach to monkeypox vaccination off to a rocky start

Earlier this month, the Biden administration authorized splitting single monkeypox vaccine doses five ways to help address shortages of Jynneos. But drawing five doses out of one vial is proving to be challenging, if not impossible, local public health officials say. Some clinics are reporting that the caps on vials sometimes break before all available doses have been withdrawn. That means remaining doses are wasted.
 
There may be workarounds, and there are precedents for fractional dosing from past outbreaks, such as yellow fever in Africa in 2016. But in the U.S., the change in both dosing and in administration — into rather than under the skin — wasn’t seamless. “I think the challenge is that the public heard this announcement as if it were ready to go,” Caitlin Rivers of Johns Hopkins said. STAT’s Helen Branswell and Theresa Gaffney have more.

Pfizer asks FDA to authorize its updated booster, minus the clinical trial part

If you’ve been watching for the next Covid vaccine booster, you’ll want to know that Pfizer and BioNTech have asked the FDA to authorize their new shot aimed at the Omicron BA.4/BA.5 variants. But here’s a twist: the companies said in a press release they expect their clinical trial to test the safety, tolerability, and effectiveness of the vaccine will start this month. That means data won’t be available yet for the FDA to consider, STAT’s Matthew Herper points out. 

There are two ways to look at the move (which our colleague Helen Branswell likened to building the ship while sailing it): The bold move to get ahead of the fast-mutating coronavirus could be controversial. Or it could have a huge payoff. Also, STAT’s Edward Chen reports on scientists inching closer to home Covid antibody tests.

After 50 years in public service, Fauci to step down


 (J. Scott Applewhite/AP)

Now it’s official: Anthony Fauci (above), the top U.S. infectious diseases official for decades and a leading researcher on crises from HIV to Covid-19, announced yesterday that he would be stepping down from his positions in December. Fauci, 81, has directed NIAID for 38 years, and he has been President Biden’s chief medical adviser since Biden took office.

Even last month, Fauci was clear that he wasn’t going to wait for some “ending” to Covid to consider his next steps. “We’re in a pattern now. If somebody says, ‘You’ll leave when we don’t have Covid anymore,’ then I will be 105. I think we’re going to be living with this,” he told my new colleague Sarah Owermohle, writing then for Politico, in an interview on the NIH campus.

However, his December move is unlikely to stall congressional critics eager to investigate NIAID research funding and unproven theories about the origins of the virus. “Fauci’s resignation will not prevent a full-throated investigation into the origins of the pandemic,” tweeted Kentucky Republican Sen. Rand Paul, who’s already clashed repeatedly with Fauci during Senate hearings on the pandemic. STAT’s Andrew Joseph has more.

Closer look: Rare kidney diseases see a surge in research

(COURTESY JUDY AKIN)

Judy Akin (above, with her son, Alexander) didn’t know she had a rare kidney disease. Like many people with rare disorders, she had to wait years and go through a dramatic turn of events before she learned she actually had a very rare form of a very common kidney disease: IgA nephropathy. There is no cure; not even transplants are a lasting fix for patients, who are often diagnosed in their 20s and 30s. And for a long time, as nephrology research in general languished, there was only a single FDA-approved treatment.

But in the last decade, a simpler, faster regulatory path has opened the door for dozens of other possible IgAN treatments, ushering in a new era of innovation in rare kidney diseases, researchers, pharma executives, and advocates told STAT’s Isabella Cueto. “It’s a golden age of IgA nephropathy,” said IgAN researcher Jonathan Barratt. Read more about what that means, for patients and for drug development.

Ebola death linked to 2018-2020 DRC outbreak

It has been confirmed that a woman who died last week in the North Kivu region of Democratic Republic of Congo was infected with Ebola. But an analysis suggests this isn’t a new spillover from nature, scientists from DRC’s National Institute of Biomedical Research reported yesterday. She was treated for 23 days in a Beni hospital, where her Ebola infection was not recognized, according to their report, posted on Virological.org. The viruses that infected her were closely linked to those that circulated in Beni in late 2018, during a two-year outbreak that ravaged the region.

“Our initial findings indicate that this case likely represents a new flare-up of the 2018-2020 Nord Kivu/Ituri EVD outbreak,” said the report. The suggestion is she was either a persistently infected survivor who suffered a relapse, or she contracted the virus from a survivor who had a persistent infection. There is a risk of onward spread from this case. The woman’s burial may not have been safe, as her family collected her body before an Ebola diagnosis was made. So far 131 contacts who were near her in the hospital have been identified, including patients and 60 health care workers — 59 of whom were vaccinated.

Lifespan dropped more in some states than others


 

Here’s the bottom line: Overall, U.S. life expectancy at birth declined by 1.8 years from 2019 to 2020, a new CDC report says, mostly thanks to the Covid-19 pandemic and to increases in unintentional injuries — mainly drug overdose deaths. There is variation: Hawaii had the highest life expectancy (80.7 years) with the smallest decrease (0.2 years) and Mississippi had the lowest life expectancy (71.9 years), but New York had the biggest drop (3 years). 

Life expectancy was higher for females in all states and Washington, D.C. Life expectancy for the entire U.S. was 77 overall — 74.2 for males, and 79.9 for females. States with the highest life expectancy clustered in Western (California, Hawaii, Idaho, Oregon, and Washington) and Northeastern states (Connecticut, Massachusetts, New Hampshire, Rhode Island, and Vermont), but also included Colorado, Minnesota, and Utah.

 

What to read around the web today

  • Despite Newsom’s veto, S.F. might push ahead with supervised drug consumption sites anyway, San Francisco Chronicle
  • In early research, an AI model detects signs of Parkinson’s using breathing patterns, STAT
  • Family planning clinics, a safe space for transgender patients, face a new battle after Roe v. Wade, The 19th
  • When spinal fluid from ALS patients was put into mice, the mice got weak. An unlikely protein could be the culprit, STAT
  • Zapping the brain with electricity shown to boost older people’s short- and long-term memory, STAT
  • If humans went extinct, would a similar species evolve? Wired

Thanks for reading! More tomorrow,

@cooney_liz
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