Advice on Covid boosters, medical devices and cybersecurity, & pressure on biopharma to reduce their carbon footprints

An expert panel told the WHO Covid boosters' benefit is "quite marginal" for people at medium or low risk of severe illness from the virus.

March 29, 2023 Check out STAT+

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By Elizabeth Cooney Reporter, Morning Rounds Writer

Good morning. We have news about Covid boosters, medical devices, and long-tailed macaques, just for starters.

coronavirus Consider Covid boosters just for people at high risk, WHO panel suggests Calling the benefit of Covid vaccine boosters "quite marginal" for people at medium or low risk of serious illness from the coronavirus, an expert panel to the WHO advised countries to focus on national conditions and health spending priorities when deciding who should get the shots. "The rationale there is that the benefit of these additional boosters is actually quite marginal, based on what we know of the immune status of these people," committee chair Hanna Nohynek said during a news conference yesterday outlining the SAGE's new recommendations. SAGE — the Strategic Advisory Group of Experts on Immunization — isn't telling countries not to offer boosters to people at low or medium risk. But with hybrid immunity — that combination of infection and vaccination — growing, boosters' added protection is small. In fact, the group said, countries might do better to launch catch-up campaigns for other vaccine-preventable diseases. STAT's Helen Branswell has more. health tech FDA now requires medical devices to be secured against cyberattacks Now it's the law. Starting today, companies cannot sell their internet-connected medical devices unless they have first shown the FDA a serious cybersecurity plan. And the agency has $5 million to enforce this — an upgrade from past resources. "FDA is not going to have to argue with people anymore," said Naomi Schwartz, a senior director at cybersecurity consulting company Medcrypt and former reviewer at the FDA. "It's going to increase the scrutiny." You may remember a case dating to 2008, when researchers demonstrated that a pacemaker was hackable. Fifteen years later, the vulnerability of medical devices continues to be a real concern. The new law directs device makers to develop better post-market surveillance processes for cybersecurity, requiring device makers to give the FDA a "software bill of materials" listing open-source and third-party software in a code base. STAT's Lizzy Lawrence has more. drug development How a monkey-smuggling ring in Cambodia is worrying biopharma researchers here Wong Maye-E/AP There's a potential crisis looming in drug and gene therapy development whose origins go back to a smuggling ring in Cambodia. While U.S. federal officials continue to investigate illegal sales of poached monkeys, biotech and pharma companies' requests to import long-tailed macaques have been denied. These non-human primates, prized for their usefulness in toxicology studies needed to say an experimental treatment will be safe in humans, cost upwards of $25,000 each, compared with $10,000 or less three years ago. Beyond any concerns about the wild (as opposed to lab-bred) long-tailed macaques being endangered, using monkeys captured in the wild would be problematic for scientific reasons: They might carry diseases and have compromised immune systems, both of which would imperil research studies. The situation raises the specter of costly delays in early-stage biopharma research. Meanwhile, some companies are looking elsewhere on the phylogenetic tree for testing. That could mean pigs. STAT's Ed Silverman and Damian Garde explain.

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Closer Look Biotech and pharma companies face pressure to take climate action Christine Kao/STAT Pressure is building on biotech and pharma companies to do their part to minimize climate change by shrinking their carbon footprints. And the impetus often comes from their employees — as simple as suggesting that labs recycle plastic pipette tips — as well as from investors and government regulators demanding answers on what companies are doing. STAT contributor Betsy Ladyzhets brings us up to date on industry efforts: One example: AstraZeneca is removing single-use plastics from packaging and, with its device partner Honeywell, developing an asthma inhaler that doesn't emit greenhouse gasses. One need: Emissions in the health and biotech sectors tend to be scope 3 emissions, coming from products and supply chains. That means because they're harder to track, better tools are required. One hopeful view: "This is an industry that knows the science," said James Connelly, CEO of My Green Lab, a nonprofit focused on sustainability in science. Read more. Health Children's hospital stays for mental health conditions are soaring Whether you measure them by sheer number or how they compare to other conditions or how serious the reasons behind them are, mental health hospitalizations for children rose significantly from 2009 to 2019, a new study in JAMA Pediatrics reports. The number of admissions to acute care hospitals grew by 25.8%, accounting for more than a quarter of all hospital days and for half the transfers to other facilities of children and adolescents aged 3 to 17 years. Attempted suicide, suicidal thoughts, or self-injury diagnoses more than doubled, from 30.7% in 2009 to 64.2% in 2019.  The researchers remind us that more than one-third of counties in the U.S. — and half of rural counties — do not have an outpatient mental health facility to treat children. As for what caused the steep increase in hospital stays, the authors say social instability, peer and family conflict, the increasing prevalence of mental health conditions, and shortages of mental health professionals might be responsible. If you or someone you know may be considering suicide, contact the 988 Suicide & Crisis Lifeline: call or text 988 or chat 988lifeline.org. For TTY users: Use your preferred relay service or dial 711 then 988. health tech While telehealth plummeted, use of retail clinics rose Here's one view of how the pandemic is changing the landscape for health care in the U.S.: While telehealth use rocketed upward by 5,017% from 2016 to 2021, it fell 76% post-lockdown from 2020 to 2021, a new white paper from FAIR Health tells us. More startling, in that same year retail clinic use grew 51%, the biggest bump among alternatives to traditional doctors' offices. In other settings, from 2020 to 2021 use rose 14% in urgent care centers but dropped 7% in ambulatory surgery centers and 15% in ERs.  Telehealth still had the most medical claim lines (services submitted for payment), amounting to 3.7% of all medical claim lines nationally, higher than ERs, urgent care centers, ambulatory surgery centers, and retail clinics. As in 2019 and 2020, the most common telehealth diagnostic category in 2021 was mental health conditions, which climbed from less than half in 2020 to more than half in 2021.

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Thanks for reading! More tomorrow,

elizabeth.cooney@statnews.com

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