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FDA on bivalent Covid vaccines, hospital safety data will be harder to find, & the fraught boom in developing contraceptives

  

 

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Good morning. We're taking an extra-long weekend to celebrate Independence Day, so we'll be back on July 6.

FDA sets Omicron subvariants as the target for reformulated vaccine

Just when the BA.4 and BA.5 variants of Omicron are together causing the majority of infections in the U.S. and building a global presence, the FDA has advised vaccine makers to reformulate their Covid-19 shots to target the subvariants as well as the original strain of the virus. The FDA made its recommendation yesterday so that vaccine makers have enough time to adapt their formulas and manufacture shots should a fall and winter booster campaign be necessary. The two-component shot is known as a bivalent vaccine.

The agency’s announcement follows a meeting Tuesday with its outside vaccine experts, who voted overwhelmingly in favor of including an Omicron component in updated booster shots. STAT’s Andrew Joseph explains.

Biotechs developing contraceptives say their work is urgent — and fraught

Biotechs creating new forms of birth control say they’re doubling down after Roe v. Wade was overturned. That makes sense, given how Google searches for “birth control” have risen sharply in the U.S. since the decision — especially in states that now have abortion bans. But it’s not that simple, STAT’s Jonathan Wosen reports. Biotech executives now worry that their efforts to reduce unintended pregnancies could also be under attack because the court’s ruling has clouded the future of contraception.

For now, they are proceeding with their work, Jonathan says, including a hormone-free cream that maintains the vagina’s naturally acidic, sperm-killing environment; an estrogen patch; an intravaginal ring; and yes, a male contraceptive. “This is now a chance for all the men who want to stand up and support women,” Nadja Mannowetz of YourChoice Therapeutics said.

How dengue and Zika infections could make people more attractive to mosquitoes

Mosquitoes carrying dengue or Zika virus can make you sick when they bite you. New research shows that it can work the other way around, too. A new study in Cell concludes that mosquitoes that aren’t already carrying the viruses could be more drawn to sick humans, become infected, and go on to infect more humans. Starting with experiments in mice, the scientists first narrowed down the specific scent emitted from both Zika- and dengue-infected mice that makes them more attractive to mosquitoes than those without the viruses.

Then they applied the scent, from the volatile compound acetophenone, to people’s hands. That confirmed the attraction mosquitoes had, beyond the known appeal of body temperature, carbon dioxide, and other scents. The scientists also found a potential route to neutralize the olfactory flag. STAT’s Theresa Gaffney has more.

Closer look: Medicare plans to stop posting some hospital safety data

(STAT, PHOTO COURTESY ANN MACDONALD)

After Ann MacDonald’s 82-year-old mother, Betty (above left), died in a Rhode Island hospital after developing sepsis after surgery, she has wondered about hospital safety. She turns to Care Compare, a federal government website that compiles hospital quality data in a user-friendly format, to look at its star ratings whenever she or a loved one needs hospital services. But Care Compare shrank during the pandemic, and Medicare, the federal agency that maintains the website, wants to trim even more of the measures from the data it’ll release next year.

Medicare proposes to keep under wraps a composite score made of 10 metrics of patient safety and adverse events, including pressure ulcers, hip fractures, and sepsis after surgery, the condition that killed MacDonald’s mother. Patient safety groups aren’t buying the agency’s argument that the change is fair given hospitals’ pandemic strain. STAT’s Tara Bannow explores.

After Roe, it looks like a Cambridge Analytica moment

Cast your mind back to 2018, when the tech industry found itself under fire for a scandal involving Cambridge Analytica, which collected and used the data of millions of Facebook users, seemingly without their consent. It prompted a public outcry, congressional hearings, a $5 billion fine, and permanently altered the discourse around how social media companies use data. Today, in the wake of the Supreme Court decision overturning Roe v. Wade, health data privacy is getting its own Cambridge Analytica moment.

Multiple experts invoked Cambridge Analytica as a reference point for the scrutiny health data practices could rightfully draw. “The lack of a national data privacy protection law is hurting everything,” Lisa Bari of Civitas Networks for Health told STAT’s Mario Aguilar. “It’s hurting people’s health. It’s hurting people’s privacy. It’s making it hard to exchange data for permitted purposes.” Read more.

Covid vaccines protect people of all body weights

Early in the pandemic, researchers warned that people with higher body weight were at higher risk of severe Covid-19. Once vaccines became available, concern continued because previous studies had shown flu shots were less effective in people with obesity, possibly because of an altered immune response. A large new study just out in Lancet Diabetes & Endocrinology is more hopeful. Compared to unvaccinated people, two Covid vaccine doses were effective at preventing severe illness across the spectrum, in people who are underweight, overweight, or who have obesity. 

There were some differences among vaccinated people: People with a very low or very high BMI were at a greater risk of hospitalization and death compared with healthy weight vaccinated people. The authors say that could be caused by a reduced immune response, frailty, or other conditions associated with low body weight. 

 

What to read around the web today

  • FDA planning to allow clinical trials of pig organ transplants, Wall Street Journal
  • Justice Thomas cites debunked claim that Covid vaccines are made with cells from 'aborted children,' NBC News 
  • Democrats tweak their drug pricing plan in last-ditch effort to pass reforms, STAT
  • CDC: New listeria outbreak tied to 23 illnesses, 1 death, Associated Press
  • A Celldex treatment induces symptom relief in patients with chronic hives, STAT

Thanks for reading! More next week,

@cooney_liz
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