Monday Roundup

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From Capitol Hill —

Roll Call reports that

House Democrats introduced a government funding stopgap Monday that would extend current spending levels through March 11 as appropriators continue to negotiate topline spending levels for a fiscal 2022 omnibus bill. 

The move would buy Congress an extra three weeks to complete work on an overdue omnibus package for the fiscal year that began last October. The government is currently operating on a continuing resolution that expires on Feb. 18.

Per the Roll Call article, Congress expects to meet the March 11 deadline with a consolidated appropriations bill for the current government fiscal year.

Reuters reports that the House also will vote on the Postal Reform bill (HR 3706) tomorrow. Here is a link to the House Rules Committee website describing the actions that the Rules Committee took on HR 3706 today to line up a vote for tomorrow.

From the Omicron front —

According to the CDC’s COVID Data Tracker, as of today, 90 million out of 213 fully vaccinated Americans (42%) have received a Covid booster. In his New York Times column this morning, David Leonhardt writes that the relatively slow adoption of boosters is not a function purely of skepticism. Rather

The vaccinated-but-unboosted more closely resemble the country as a whole. Millions of Americans who have already received two vaccine shots — eagerly, in many cases — have not yet received a follow-up. The unboosted include many Republicans, Democrats and independents and span racial groups. * * *

The most urgent problem involves the unboosted elderly. (About 14 percent of Americans over 65 eligible for a booster had not received one as of mid-January, according to Kaiser.) But some younger adults are also getting sick as their vaccine immunity wears off.

A recent study from Israel, published in The New England Journal of Medicine, was clarifying. For both the elderly and people between 40 and 59, severe illness and death were notably lower among the boosted than the merely vaccinated. For adults younger than 40, serious illness was rare in both groups — but even rarer among the boosted: Of the almost two million vaccinated people ages 16 to 39 in the study, 26 of the unboosted got severely ill, compared with only one boosted person.

“Boosters reduce hospitalization across all ages,” Dr. Eric Topol of Scripps Research has said. As Dr. Leana Wen wrote in The Washington Post, “The evidence is clear that it is at least a three-dose vaccine

Mr. Leonhardt places responsibility for the booster gap on the fragmented U.S. health system and the failure of government experts to make themselves understood to the American people. Health plans may want to lend a hand here.

The National Institutes of Health informed us

Pregnant women with COVID-19 appear to be at greater risk for common pregnancy complications — in addition to health risks from the virus — than pregnant women without COVID-19, suggests a study funded by the National Institutes of Health.

The study, which included nearly 2,400 pregnant women infected with SARS-CoV-2, found that those with moderate to severe infection were more likely to have a cesarean delivery, to deliver preterm, to die around the time of birth, or to experience serious illness from hypertensive disorders of pregnancy, postpartum hemorrhage, or from infection other than SARS-CoV-2. They were also more likely to lose the pregnancy or to have an infant die during the newborn period. Mild or asymptomatic infection was not associated with increased pregnancy risks.

“The findings underscore the need for women of child-bearing age and pregnant individuals to be vaccinated and to take other precautions against becoming infected with SARS-CoV-2,” said Diana Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which funded the study. “This is the best way to protect pregnant women and their babies.”

The American Hospital Association offers six tips for health care leaders looking to build vaccine confidence among pregnant women.

The Wall Street Journal reports today

Drugmaker Shionogi & Co. said it plans to seek approval this month to sell its Covid-19 treatment pill in Japan after the company found that in human trials the pill had strong virus-fighting ability compared with Pfizer Inc.’s Paxlovid. 

Shionogi acknowledged that studies of its drug are much smaller than Pfizer’s and have yet to prove effectiveness in preventing serious Covid-19 cases. Pfizer said its final-stage trial, which included more than 2,000 patients, showed Paxlovid cut the risk of hospitalization or death by 89% if patients took the pill within three days of diagnosis. 

Still, Shionogi said it believed its trials to date, covering about 400 mostly Japanese patients, would offer sufficient evidence to seek approval in Japan, where the Pfizer drug is expected to be approved shortly, but is likely to be in limited supply. Shionogi said its trial found the pill, code-named S-217622, neutralized the virus quickly and didn’t cause serious or lasting side effects. 

The more, the merrier.

In other news, Fierce Healthcare tells us

CVS Health is teaming up with Medable to access and engage around clinical trials at select MinuteClinics, the healthcare giant announced Monday.

CVS Health Clinical Trial Services, a new arm at the company launched last May, will harness Medable’s software platform to deliver clinical trials with a focus on accessibility and retention to enhance the effectiveness of research, according to the announcement.

The companies note that while clinical trials are crucially important to test the efficacy of innovative pharmaceuticals, less than 4% of Americans actually participate in them. In addition, 30% of participants drop out before trials are completed, and 80% of studies are unable to make enrollment deadlines.

Tony Clapsis, general manager and senior vice president of CVS Health Clinical Trial Services, said in a statement that CVS has the ability to make a significant impact on outreach about trials to underrepresented people as more than 40% of vulnerable populations live within five miles of one of its pharmacies.

Smart move.

STAT News reports

  • “Some of the nation’s most influential doctors and public health groups are orchestrating a mad-dash effort to convince senators to confirm Robert Califf, President Biden’s pick to lead the Food and Drug Administration. * * * The pressure campaign comes amid growing signs that Califf’s nomination is in serious trouble. Five Democrats in the Senate have already expressed serious concerns with Califf’s nomination and at least 10 more are still undecided about his candidacy. Quite a few Republicans in the chamber also have concerns. ‘It’s … the ‘break glass in case of emergency’ moment,’ said one patient advocate, who noted that many advocacy groups had, until recently, thought Califf would sail through his confirmation process easily.”

and

  • “When President Biden tapped Eric Lander as White House science adviser in January 2021, he tasked the renowned genomics researcher with “reinvigorating” American science. Following Lander’s stunning resignation on Monday evening, however, the question is no longer whether he’ll reinvigorate the U.S. scientific enterprise. It’s whether he’s derailed it. Lander resigned after an all-staff apology for abusive workplace behavior, which Politico first reported. In an email, Lander admitted speaking in a “disrespectful and demeaning way,” acknowledging he had failed to set a “respectful tone” for the office and that his actions reflected poorly on the administration.”

Let’s hope Lander didn’t derail efforts like the Cancer Moonshot.