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Developing an Omicron vaccine, telehealth steering clear of abortion pill, & Covid's enduring disparities

    

 

Morning Rounds Elizabeth Cooney

Good morning and welcome back to a new workweek (for most of us). Today we're catching up on Omicron and puzzling over abortion pill availability.

Updating Covid vaccines would need a global approach, FDA official says

If the FDA decides to update Covid-19 vaccines to take better aim at Omicron or other variants, it is unlikely to go it alone, a senior FDA official told STAT’s Helen Branswell. Instead, the agency expects to take part in an internationally coordinated program aimed at deciding if, when, and how to update Covid-19 vaccines. That approach would ensure decisions are not left solely to individual vaccine manufacturers, likely modeled on a program used for decades to decide which strains should be included in influenza vaccines, the official said, speaking on condition of anonymity. Vaccine manufacturers are already testing Omicron-based vaccines; partners Pfizer and BioNTech expect to have data by early March. But “we do not particularly relish the idea of each manufacturer having their own flavor of secret sauce,” the official said. Read more.

Meanwhile, an expert panel at the World Economic Forum delivered a mix of good news and bad news yesterday: More variants will emerge, but vaccine production is accelerating and research is progressing toward a combined shot that may be able to attack these different variants. STAT's Ed Silverman has more.

Covid disparities extend to treatment, study finds

Racial and ethnic disparities in who gets infected with Covid-19 and who dies are well-known. Now a new CDC study reports significant differences also exist in who receives monoclonal antibody treatments intended to make Covid illness less severe if infused or injected soon after infection. These treatments were offered overall to only 4% of more than 800,000 patients studied, but from November 2020 through August 2021, Hispanic patients received them 58% less often than non-Hispanic patients, and Black (22%), Asian (48%), or other race (47%) patients less often than white patients. When the antiviral remdesivir and the steroid dexamethasone were administered in the hospital for Covid, differences were smaller. The study didn’t identify a cause for the disparities, but the authors point to success when monoclonal antibodies — typically outpatient treatments — are brought to patients via a mobile infusion unit.

Rapid Covid tests coming to U.S. website tomorrow

Tomorrow’s the first day you can sign up on the federal website covidtests.gov to order free rapid Covid-19 tests (four per household). The White House said last week it would take seven to 12 days for the test kits to arrive, which could conceivably coincide with Omicron cases sliding downward from their current heights. Accuracy of the rapid antigen test has come under fire after one small study warned of missed infections; meanwhile, the Biden administration’s handling of the pandemic is getting poor reviews, according to new poll in which just 36% of respondents believe the response is "going well." Late last week the CDC issued widely anticipated guidance on masks, encouraging people to wear N95 or KN95 masks rather than cloth masks to slow the spread of the coronavirus.

Inside STAT: Telehealth startups targeting women’s sexual health steer clear of abortion pill

The abortion pill is a combination of mifepristone and misoprostol tablets. (elisa wells/plan c/afp via getty images)

The online pharmacy Nurx advertises itself as the company that “gives women sexual freedom.” Hims & Hers aims to “eliminate stigma” and improve health care access. Tia offers telehealth services focused on “whole woman, whole life.” And on the day that the FDA declared abortion pills will be permanently available by mail, The Pill Club tweeted its support. But one month after the FDA’s announcement and close to two years after abortion pills became available by mail in 13 states, none of these telemedicine companies — though they’re explicitly focused on women’s sexual health — has chosen to offer the treatment. To offer telemedicine abortion, the companies would have to contend with regulatory hurdles. And divisiveness around abortion, combined with the reduced demand compared to birth control pills, make telemedicine abortion an unattractive business opportunity, former employees told STAT’s Olivia Goldhill. STAT+ subscribers can read more here.

Losing taste or smell with Covid infection tied to genetic variants

Scientists have found a genetic clue to why some people infected with Covid-19 lose their sense of taste or smell and others don’t. In a Nature Genetics study out yesterday, researchers from the consumer gene-testing company 23andMe describe a genome-wide association study based on responses to a survey of nearly 70,000 people living in the U.K. or U.S. who had Covid. Their analysis turned up genetic variants near two genes that increased by 11% the chances that a person would lose smell or taste after infection. The two genes, UGT2A1 and UGT2A2, encode enzymes produced in cells lining the inside of the nose that are involved in eliminating odorants that bind to receptors involved in smell detection. Caveats: Most survey participants were of European ancestry, their symptoms were self-reported, and the question they answered combined taste and smell.

ICYMI: 'Pharma bro' banned from pharma

“Pharma bro” Martin Shkreli was ordered to pay $64.6 million in profits and banned for life from the pharmaceutical industry for an infamous episode several years ago in which his company purchased an old, lifesaving medicine and then boosted the price by 4,000% overnight. Friday’s decision follows a trial in which Shkreli, a former hedge fund manager reviled for his smug responses to an outraged public, was accused by federal and state authorities for stifling competition. Already serving time for unrelated securities fraud, Shkreli in this case is being punished for illegally jacking up the price of Daraprim, a drug taken by people with HIV, by more than 4,000% — from $17.50 a tablet to $750. STAT’s Ed Silverman has more.

 

What to read around the web today

  • As nations decide to live with the virus, some disease experts warn of surrendering too soon. Washington Post
  • The Covid-risk social contract is under negotiation. The Atlantic
  • Jordan Thomas’s army of whistle-blowers. The New Yorker
  • Opinion: Is it time for big biopharma companies to rethink the use of federal funding for R&D? STAT
  • Real estate developer reneges on multimillion-dollar pledge to Harvard-led Covid project. Boston Globe

Thanks for reading! More tomorrow,

@cooney_liz
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