Happy Flag Day!

According to the U.S. Senate Press Gallery, sometime after 11:30 am tomorrow morning, the Senate will hold a cloture vote on Kiran Ahuja’s nomination to be OPM Director. If the cloture vote receives majority approval (assuming a quorum exists), then the Senate will vote to confirm Ms. Ahuja’s nomination sometime after 2:30 pm tomorrow.

From the COVID-19 front

• MedPage Today reports that “While experience so far with COVID vaccines shows that some are associated with very rare, early side effects, experts say they have confidence about the long-term safety of these vaccines. That’s because past experience shows that severe side effects from vaccines most often appear within a time frame of about 6 weeks after vaccination, according to Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).”
• Bloomberg reports that “Covid-19 vaccines from Pfizer Inc. and AstraZeneca Plc are highly effective after two doses at preventing hospitalization of those infected with the delta variant, underscoring the urgency in getting people fully protected, according to health authorities in England.” David Leonhardt adds in the New York Times that

The news about Covid-19 has been mostly positive in the U.S. over recent months. The vaccines continue to work well against every variant, and the number of Americans who have gotten a shot continues to rise.

But the U.S. still faces two problems. First, the pace of vaccinations has slowed, and a substantial share of Americans — close to one third — remains hesitant about getting a shot. These unvaccinated Americans will remain vulnerable to Covid outbreaks and to serious symptoms, or even death.

Second, the Delta variant — which appears to be both more contagious and more severe than earlier versions of the virus — is spreading rapidly within the U.S., after having first been identified in India. It now accounts for about 10 percent of cases, according to Dr. Scott Gottlieb, a former F.D.A. commissioner. * * *

“The Delta variant is by far the most contagious variant of this virus we have seen in the entire pandemic,” Dr. Ashish Jha saidyesterday. “The good news is the data suggests that, if you’ve been fully vaccinated, you remain protected, that the vaccines hold up.”

The clearest place to see this pattern is Britain, where the Delta variant has spread widely and where the vaccination rate is high. In Britain, there is “still no sign of increase in deaths, well after the strain has become dominant,” as Dr. Eric Topol of the Scripps Research Translational Institute noted.

• The Boston Globe informs us that

Vaccine maker Novavax said Monday its shot was highly effective against COVID-19 and also protected against variants in a large, late-stage study in the US and Mexico.

The vaccine was about 90 percent effective overall and preliminary data showed it was safe, the company said.

While demand for COVID-19 shots in the US has dropped off dramatically, the need for more vaccines around the world remains critical. The Novavax vaccine, which is easy to store and transport, is expected to play an important role in boosting vaccine supplies in the developing world.

That help is still months away, however. The company says it plans to seek authorization for the shots in the US, Europe and elsewhere by the end of September and be able to produce up to 100 million doses a month by then.

• The Department Health and Human Services announced that it has “awarded $125 million to support 14 nonprofit private or public organizations to reach underserved communities in all 50 states plus the District of Columbia, Puerto Rico, Guam and the Freely Associated States to develop and support a community-based workforce that will engage in locally tailored efforts to build vaccine confidence and bolster COVID-19 vaccinations in underserved communities.”

Fierce Healthcare reports that

Following its acquisition of MDLive and the approval of new drugs in the market, Cigna’s Evernorth is expanding its care management program for weight loss.

The Weight Management Care Value program initially launched under Express Scripts as part of its slate of SafeGuardRx programs. Now, the company is harnessing the capabilities of other assets under its umbrella to broaden the program.

Members who enroll in the program will have access to new therapies like Novo Nordisk’s Wegovy, when clinically appropriate and prescribed by their doctor, as well as virtual care options provided by MDLive.

Here are two more OPM rule makings that were listed in OPM’s semi annual regulatory agenda that was released last Friday June 11

• OPM has in store for us a new proposed rule on FEHB Enrollment and Changes in Enrollment “The Office of Personnel Management (OPM) proposes to amend title 5 part 890 of the Code of Federal Regulations governing the Federal Employees Health Benefits (FEHB) Program to allow OPM to make improvements and clarifications to the FEHB Program’s enrollment rules and processes, including centralizing certain health benefits enrollment functions. Currently, enrollment is administered by an enrollee’s employing agency or retirement system. This rule would allow OPM to leverage necessary IT functionality in order to conduct certain enrollment functions and collect information necessary to administer FEHB enrollments with greater efficiency and in alignment with the best practices of employer-sponsored insurance programs. In addition, OPM is proposing a process that would allow an employing office or OPM to decrease an individual’s enrollment type from self plus one or self and family to self only when there is only an enrollee and no family member.”
• OPM plans to issue an interim final rule extending FEHB coverage to Tribal employees at 297 grant schools in accordance with the Consolidated Appropriations Act. This action suggests that the extension will take effect for the next Federal Benefits Open Season