Paxlovid study leaves key questions unanswered

Here’s another Paxlovid puzzler (after rebound). Pfizer issued a press release yesterday saying its study of the antiviral in Covid patients who were not at risk for severe disease didn’t show their Covid symptoms got better faster, but it did seem to prevent doctor’s visits and hospitalizations. Too few patients were hospitalized to say whether Paxlovid kept vaccinated people out of the hospital. But as STAT’s Matthew Herper and Jason Mast point out, the data do not invalidate earlier results showing Paxlovid prevents hospitalizations and saves lives in patients at high risk of severe Covid.

It may give doctors pause when prescribing for patients with no risk factors. “This reinforces that Paxlovid is not going to have a big role in vaccinated people except in people who are maybe at highest risk,” said Walid Gellad of the University of Pittsburgh. “Maybe in a bigger trial, it would be statistically significant, but the effect is small.”

FDA advisory panel backs Moderna vaccine for older kids

An FDA advisory panel voted unanimously yesterday to recommend the agency authorize the Moderna Covid vaccine for children ages 6 to 17. The vote echoes the current emergency use authorization of the Covid vaccine developed by Pfizer and BioNTech for anyone 6 and over. The FDA doesn't always follow its committee's lead, but usually does. The CDC would weigh in later this week. While the vote was unanimous, the experts raised concerns about how many doses kids would get, how that would be communicated, and about heart inflammation that can rarely occur with both Covid vaccines. STAT’s Matthew Herper explains.

Matt and Helen Branswell will be tracking today’s advisory panel meeting on Pfizer/BioNTech and Moderna vaccines for children as young as 6 months old. You can follow along here.

Now it's Omicron BA.4 and BA.5's turn

We’re still in the Age of Omicron, STAT’s Andrew Joseph reminds us, but the face of it keeps changing. As he puts it, another biological baton pass between Covid-19 variants is underway. This time Omicron BA.4 and BA.5 are chipping away at the BA.2 group’s spring dominance. More than 1 in 5 Covid-19 infections last week were caused by BA.4 and BA.5, according to CDC estimates posted yesterday, up from 13% the previous week.

People who were infected by an earlier Omicron version could be susceptible to an infection from BA.4 or BA.5 not long after they recover, but if they’ve been vaccinated or had prior infections, they still had protection against more serious outcomes. As of now, BA.4 and BA.5 do not seem to cause more severe disease compared to other forms.

Closer look: Many Blue Cross Blue Shield plans don’t pay taxes, but do get refunds

This is mind-boggling: Blue Cross Blue Shield health insurance companies have received billions of dollars from the federal government over the past four years as part of a tax system that has favored, and has been partly molded by, Blue Cross Blue Shield. For example: The parent of the Blues plans in Illinois, Montana, New Mexico, Oklahoma, and Texas hasn’t paid federal income taxes since 2017 but got almost $3.6 billion in refunds while recording hefty profits when Covid forced people to put off medical care.

STAT’s Bob Herman reviewed four years of audited financial statements for 32 nonprofit BCBS insurers and identified 12 that haven’t paid any net federal taxes since January 2018, the date of the corporate tax system’s overhaul. The government has refunded more than $6.6 billion to those dozen insurers. Bob has more on the mechanisms and the lobbying involved.

WHO to convene experts on monkeypox spread

As monkeypox continues its spread through Europe, parts of the Americas, and beyond, the WHO will gather outside experts on June 23 to weigh whether the current outbreak warrants the declaration of a public health emergency of international concern. There is ample evidence that a public health response will need international coordination, STAT’s Helen Branswell writes. Vaccines and drugs that are effective to prevent and treat monkeypox are in limited supply globally. Director-General Tedros Adhanom Ghebreyesus said yesterday the WHO is working with countries and other partners to develop a mechanism for fair distribution of those supplies.

Tedros also confirmed that the global agency is is working with partners to devise new names for the monkeypox virus, the disease, and its clades, now named after where the viruses are found in nature. A contingent of African scientists urged the action.

3D mammography works better for some patients

Breast cancer screening comes with the hope of detecting tumors in time to treat them before they grow and spread. It also comes with concerns about false positives, followed by what may be unnecessary biopsies and overdiagnosis, in which tumors that wouldn’t cause harm lead to unnecessary treatment. The challenge of distinguishing harmless from dangerous growths is one that better imaging is meant to address. A new study in JAMA concludes that 3D imaging known as digital breast tomography was better than digital mammography, but only for the 3.6% of patients with the densest breasts and high breast cancer risk.

Also: For 44% of study participants with non-dense breasts and low to average risk for breast cancer, DBT meant fewer false-positives and biopsies. “DBT is associated with decreased false-positive results, although the association with breast cancer mortality is uncertain,” an editorial notes.

What to read around the web today

Monkeypox vaccines are too gnarly for the masses, The Atlantic
When Covid came for Provincetown, Wired
In a first-of-its-kind deal, major drugmaker licenses antibiotic production for low-income countries, STAT
New Jersey hospitals scrap merger after FTC challenge, STAT
Adam’s Take: Amylyx’s case for approval of its ALS drug isn’t ironclad. Here’s why I think it will still happen, STAT