Good morning. Today I'm teaming up with STAT intern Akila Muthukumar, who also collaborated with STAT's Usha Lee McFarling and Katherine Gilyard to report on monkeypox disparities.

Two children have died from acute liver failure after treatment with Novartis' gene therapy

Two children have died from acute liver failure after being given Zolgensma, a gene therapy sold by Novartis to treat spinal muscular atrophy, a rare and sometimes fatal genetic disorder that causes muscle wasting and weakness. The deaths occurred over the past few months in Russia and Kazakhstan, STAT’s Ed Silverman reports in an exclusive, approximately five to six weeks after the $2.1 million, one-time therapy was infused and between one and 10 days after corticosteroid tapering occurred, which is done to ensure proper liver function.

Although acute liver failure appears in the product labeling information, a Novartis spokesperson acknowledged these episodes marked the first fatal cases attributed to the side effect. “While this is clinically important safety information, it is not a new safety signal and we firmly believe in the overall favorable risk/benefit profile” of the treatment, they told Ed. Read more.

CDC relaxes Covid quarantine, testing guidelines

Are you ready for more CDC recommendations on Covid? The agency now says people not up to date with Covid-19 vaccination who are exposed to someone infected with the coronavirus no longer need to quarantine. Instead, they should just wear a mask for 10 days indoors and test on day 5. The new guidelines could ease the testing burden on schools, STAT’s Andrew Joseph writes. People showing Covid symptoms should be tested, but broader screening “might not be cost-effective in general community settings, especially if Covid-19 prevalence is low.”

Separately, the FDA warned yesterday that at-home rapid antigen tests can deliver false negatives. For those with Covid symptoms, the FDA now says take two home Covid tests over 48 hours. For those without symptoms who suspect a Covid exposure, the FDA now recommends up to three separate tests, each 48 hours apart. Read more.

Hurdles to antiviral treatment for monkeypox leave people suffering

Infectious disease doctors say there are maddening barriers to monkeypox treatment with one medication, Tpoxx, that can ease patients’ pain, fever, and fatigue. The antiviral isn’t approved for monkeypox, so it’s available only under a compassionate use policy that requires a “Kafkaesque amount of paperwork,” 90-minute appointments, and two follow-up visits, even after CDC streamlined the process. That leads to further delays in care, especially in short-staffed or emergency settings, New York City health department member Mary Foote said on a call with reporters yesterday. “We really cannot be complacent about this needless suffering.”

Two other developments:

Writing in a STAT First Opinion, epidemiologist Caitlin Rivers and infectious disease specialist Tom Inglesby express concerns about the safety of ACAM2000, a smallpox vaccine eyed for monkeypox, while demand for Jynneos far exceeds the supply.
Africa still doesn’t have a single dose of Jynneos, the Associated Press reports.

Closer look: Racial disparities in monkeypox infections are stark in some locales

(SPENCER PLATT/GETTY IMAGES)

The current monkeypox outbreak has many unknowns, but in one respect it’s familiar: In some states and localities, racial disparities are alarming. In Georgia, 82% of people with the disease are Black. In North Carolina, it’s 70%. But in other places that released detailed demographic data, there are fewer and sometimes no apparent racial or ethnic disparities in cases.

Some experts told STAT’s Usha Lee McFarling, Katherine Gilyard, and Akila Muthukumar the disparities come as no surprise. That’s because they track with the early days of the HIV epidemic — and the more recent emergence of Covid-19. “We saw it with HIV among marginalized communities in the 1980s just as we saw the tepid response to Covid-19 that disproportionately impacted people of color and those living in poverty,” said Joia Mukherjee, the chief medical officer for Partners in Health. “It’s inexcusable.” Read more about access to vaccine, health care, and data.

Over 1 in 4 children hospitalized for Covid or MIS-C had later impairment

Research is adding up on Covid-19’s impact on children. Last week CDC reported a small increased risk of blood clots, heart conditions, kidney failure, and type 1 diabetes a month to a year after Covid infection. Today a study in Pediatrics involving 25 children’s hospitals says more than 1 in 4 children hospitalized for Covid or for the multi-inflammatory syndrome that can follow Covid had lingering symptoms or impaired activity two to four months later.

The most common symptoms were fatigue, shortness of breath, and cough, while a smaller proportion weren’t able to exercise, sleep, or do their homework. Most of the children still experiencing problems had organ systems affected by acute Covid, or after MIS-C, previous conditions such as asthma or obesity. The study ended before vaccines were available; the researchers urge careful follow-up after Covid and vaccination to prevent it.

Survey: Pandemic divisions felt around the world

A new Pew Research Center survey across 19 countries found that a median of 61% think their country is more divided now than it was prior to the pandemic. However, of the more than 24,500 respondents, a median of 68% said they think their country has done a good job with its pandemic response. Here’s more:

Divisions: The U.S. had the highest share of respondents (81%) who said their country is more divided now than pre-pandemic and who said they saw their country struggling to handle the pandemic in ways that reveal political system weakness (66%).
Approval: Supporters of a country’s governing party were much more likely to say their government is handling the pandemic well than those who did not support the ruling party.
Vaccine importance: Across the countries, around two-thirds or more say it’s at least somewhat important to get a vaccine. About 7 in 10 in Singapore, Sweden, and Spain feel that vaccines are very important, while 4 in 10 or fewer in France, South Korea, Hungary, and Poland agree.

What to read around the web today

Medical boards that can strip abortion providers of licenses are stacked with Republican donors, Mother Jones
Walgreens offers bonuses up to $75,000 to recruit pharmacists, Wall Street Journal
One Medical’s dueling offers from Amazon and CVS signal a start to health tech bidding wars, STAT
TB is good at resisting antibiotics. Here are some new ideas to outsmart the bacteria, NPR
The Pharmalot view: Eli Lilly’s after-the-fact statement on Indiana’s abortion law sends a disingenuous message, STAT
Federal judge dismisses doctor’s case that argued surprise billing law was unconstitutional, STAT