Monday Roundup

Photo by Sven Read on UnsplashFr

From the Delta variant front, STAT News informs us that

Pfizer and BioNTech announced Monday that their Covid-19 vaccine was 100% efficacious in preventing infections in 12- to 15-year-olds, measured from seven days to four months after administration of the second dose of the vaccine.

The companies said the new data — a longer-term analysis of a Phase 3 trial conducted in 2,228 participants — will form the basis of an application to the Food and Drug Administration for an extension of their Covid-19 vaccine license to cover youths in the age group. 

“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a Covid- 19 vaccine in individuals 12 to 15 years of age,” Ugur Sahin, CEO and co-founder of BioNTech, said in a statement. “The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favorable safety profile of our Covid-19 vaccine across adolescent and adult populations.”

Astra-Zeneca announced late last week that

New data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination.

In an analysis of the ongoing PROVENT trial evaluating a median six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%.

About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.This includes people with blood cancers or other cancers being treated with chemotherapy, patients on dialysis, those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.2-6

The AZD7442 PROVENT trial is the first Phase III trial prospectively designed to evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic COVID-19, with targeted inclusion of high-risk and immunocompromised participants. More than 75% of PROVENT participants at baseline had co-morbidities that put them at high risk for severe COVID-19 if they were to become infected, including people who are immunocompromised and may have a reduced immune response to vaccination.

There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with  AZD7442 at either the primary or six-month analyses. In the placebo arm, there were two additional cases of severe COVID-19 at the six-month assessment, for a total of five cases of severe COVID-19 and two COVID-related deaths.

Developing new early treatment options is encouraging news. Kaiser Health News reminds us that the success of these new early anti-viral treatments hinges on widespread availability of inexpensive at home COVID tests.

From the Delta variant vaccine mandate front, Federal News Network tells us that

More than 90% of federal employees have received at least one dose of the COVID-19 vaccine by the president’s deadline, a senior administration official said Monday.

Most of those employees are fully vaccinated, the Biden administration said. All told, some 95% of employees have taken steps to comply with the Biden administration’s federal vaccine mandate by the Nov. 22 deadline — a figure that includes partially and fully vaccinated employees, as well as those who have a medical or religious exception pending or approved.

“Critically, the Nov. 22 deadline is not an end point; we continue to see more and more federal employees providing their information and getting their shots,” the administration official said in an email.

Agencies will continue to collect information, as well as requests for exceptions “due to documented medical necessities” in the coming days, the White House said.

The Office of Management and Budget will release a more detailed breakdown of vaccination rates within individual agencies on Wednesday.

The Society for Human Resource Management offers an article about the role of boosters in employer sponsored vaccination programs:

All U.S. adults are now eligible to receive a COVID-19 vaccine booster, so long as a certain number of months have passed since their last dose. As employers revise their vaccination policies, they may be wondering if they should require workers to get an extra jab to be considered “fully vaccinated.” Here’s what employment law attorneys had to say. 

At least for now, employment law attorneys recommend that businesses hold off on mandating booster shots.

“At this point, I think it is probably too soon to make those updates,” said Jim Hermon, an attorney with Dykema in Detroit. 

John Thomas Jr., an attorney with McGuireWoods in Tysons, Va., noted that employers are focused on helping their employees get over the hurdle of initial vaccination. “Some geographic areas—and some industries—are still struggling to reach a critical mass of people willing to get the shot in the first place.”  * * *

Although it may be too soon for many employers to add booster shots to their vaccination policies, attorneys said workplace leaders can start planning now. 

“I think it is company-specific,” said Katherine Dudley Helms, an attorney with Ogletree Deakins in Columbia, S.C. Some workplaces have seen a high percentage of employees get vaccinated, she said, so it might make sense to add the boosters to their recommendations as the shots are authorized. 

On the other hand, she noted, if the workforce vaccination rate is low or vaccination has been a battle for the employer, it may be wiser to try to focus on raising the rate of initial vaccination rather than adding the booster on top of that. Even with this approach, she said, an employer can certainly support and encourage employees who are eligible and wish to get the booster shot.

“My experience is that those who do not mandate vaccinations are preparing policies and practical plans for the likelihood that they may become mandatory either because of federal requirements or because the timing is right,” Helms observed.

Just as with the initial vaccinations, she said, employers should let workers know if the company will pay for the costs associated with getting the booster, including the time spent getting the shot. Employers should also address how time off will be treated if employees have a reaction.

From the Rx coverage from, Med City News reports on Walgreen’s new strategy. “The company launched a new health division, and has doubled down on its plans to open primary care clinics with VillageMD. It faces big competitors in CVS and Walmart, and it’ll take time to see if its new strategy pays off.” Walgreen’s, of course, is not alone in this endeavor.

Neal Batra and David Betts, who have studied consumers’ thoughts on healthcare for Deloitte, said people are primarily looking for three things: meaningful interactions with their provider, visits that make economic sense, and convenience. Booking a visit a month out to spend 10 minutes with a doctor ticks none of these boxes.

“We’ve believed for a long time that this [retail approach taken by Walgreen’s, CVS Health and Walmart, among others] is the direction that consumer healthcare will go. What we see now is that playing out,” said Betts, who leads the public health transformation effort for Deloitte Consulting.

The pandemic, in some ways, accelerated that. People didn’t want to sit in busy waiting rooms, and were more open to other care modalities, like telehealth. Pharmacy chains were also given big contracts for Covid-19 testing and vaccines, driving more people to their stores.

Batra, a principal in Deloitte’s Life Sciences and Health Care practice, said “it’s super logical” for retailers to look at primary care, because it involves routine visits and engagement points.

“It’s a very natural place to enter,” he said. “Are you going to see some of these models continue what we would call an upmarket march to go after more and more complex aspects of primary care, or even dip their toe into specific therapy areas that are more specialized? It remains to be seen, but our expectation is yes.”

For example, pharmacies could offer blood-pressure measurements, and blood-glucose testing for people with prediabetes or diabetes. For retailers, the cost of doing this would be relatively low, while the value for patients would be high.

From the ACA front, the Internal Revenue Service today released a proposed rule on ACA reporting by insurers and self-funded employers, Forms 1095 and 1096. The FEHBlog still needs to review it. The reporting which was developed to support enforcement of the ACA’s tax penalties for failure to carry minimum essential coverage are a mysterious component of the zeroed out penalty world that has existed for three years. The handful of states and DC which have adopted individual mandates can use the IRS forms.

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