How a Maryland nursing home stayed coronavirus-free: 5 things to know

Though nursing homes and other long-term care facilities have been hit hard by the new coronavirus, Maryland Baptist Aged Home in Baltimore has not reported a single case of COVID-19 during the pandemic, PBS News Hour reports.

The nursing home’s director, the Rev. Derrick DeWitt, told PBS how staff managed to keep the virus out of the 100-year-old facility. Here are five things to know from the discussion:

1. The nursing home was proactive and started taking action early, when the U.S. was reporting only 15 cases or so.

2. The nursing home locked down and stopped allowing visitors at the ” very end of February, 1st of March,” the director said.

3. The facility instituted a rigorous screening process for employees coming to work, asking them details of their time outside work and taking their body temperatures.

4. The nursing home had a full-time infection control nurse who had helped set up protocols to be used in case of an epidemic or pandemic.

5. The facility took the emotional health of its residents seriously and took steps to make the lockdown easier on them, including bringing in extra activity staff to make sure that residents had visits every day.

Read the full discussion here.

https://www.beckershospitalreview.com/post-acute/how-a-maryland-nursing-home-stayed-coronavirus-free-5-things-to-know.html

CMS to send quality experts to nursing homes in COVID-19 hot spots

CMS plans to deploy groups of quality improvement experts, clinicians and consumers to nursing homes in COVID-19 hot spots, the agency said July 10.

The groups, known as quality improvement organizations, will help facilities improve care and infection control processes for Medicare patients.

CMS also is implementing an updated survey process for nursing homes to address care concerns specific to facilities in areas where COVID-19 cases are surging.

The goal is to help nursing homes improve infection control processes to limit the spread of COVID-19 among residents and staff.

To learn more, click here.

https://www.beckershospitalreview.com/post-acute/cms-to-send-quality-experts-to-nursing-homes-in-covid-19-hot-spots.html

Boehringer-backed Covid researchers ID new antibodies to fight virus

In April, Boehringer Ingelheim announced a multifaceted plan to help fight COVID-19, which included collaborating with academic researchers to find potential treatments. Now one of those research programs has uncovered 28 antibodies that the company plans to move into further testing.

A team of researchers led by Cologne University Hospital and the German Center for Infection Research studied the antibody response to COVID-19 in 12 people who recovered from the virus, as well as immune cells from 48 healthy people collected before the pandemic. By examining more than 4,000 B cells, they pinpointed antibodies with the strongest neutralizing effect on SARS-CoV-2, the virus that causes COVID-19, they reported (PDF) in the journal Cell.

The team focused on decoding the “humoral immune response” that the virus causes, which is the process by which B cells are activated to fight pathogens. They isolated 255 antibodies specific to the SARS-CoV-2 response, reconstructed them in the lab, and then tested their ability to neutralize the coronavirus.

The 28 finalists they picked were not only able to potently neutralize the virus, they also showed low levels of mutations over time. “This means that only minor changes were necessary to effectively recognize and neutralize the virus,” explained co-author Matthias Zehner of the University of Cologne, in a statement.

Comparing B cells from COVID-19 survivors to those of the 48 healthy individuals helped the team identify the top antibody candidates. In the blood samples taken pre-pandemic, they discovered “precursors of potent SARS-CoV-2-neutralizing antibodies in every single individual,” they wrote in the study, suggesting that the immune systems of healthy people may already be primed to ramp up the production of COVID-19 neutralizing antibodies in response to treatment with the drug candidates they identified.

The massive effort underway to develop vaccines and antibodies against COVID-19 is largely focused on generating antibodies targeting the spike protein that facilitates the infection of healthy cells. Eli Lilly has two such antibodies in clinical trials. Regeneron is rapidly advancing studies of its antibody cocktail. Amgen and AstraZeneca are also in a race to develop antibody treatments.

BI hasn’t provided details about which COVID research it plans to prioritize. The company has embarked on “a broad program pursuing many approaches in parallel,” said Cyrille Kuhn, executive director of research, in the April announcement.

The findings from the Cologne University-led team prompted the researchers to suggest that the COVID neutralizing antibodies they identified may be useful in both fighting active infections and preventing them in people who have come in contact with patients fighting the disease. They predicted clinical trials of the top antibody candidates could begin by the end of the year.

https://www.fiercebiotech.com/research/boehringer-ingelheim-backed-covid-researchers-identify-new-antibodies-to-fight-virus

To defeat Covid-19, deliver 70% effective vaccine, get 70% to take it – FDA official

One of public health’s greatest accomplishments was eradicating smallpox back in 1979. To eradicate SARS-CoV-2, the virus that causes COVID-19 illness, we’ll need a vaccine that’s 70% effective—and 70% of the population will need to receive it, an FDA vaccine official said Wednesday.

That’s a higher bar than the FDA set last week. To pass muster at the agency, a COVID-19 vaccine will need to be at least 50% more effective than placebo, according to new FDA guidelines.

But the agency felt a 50% efficacy requirement was a “reasonable place” and about comparable to a flu vaccine on a good year, said Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), during a webinar hosted by the Alliance for a Stronger FDA.

And despite R&D moving at record speeds, Marks cautioned that vaccines are still several months away. It’ll take “weeks to months” to get phase 3 trials enrolled, and some regimens will require two injections several weeks apart. Then, investigators will need to follow the trial participants “for a few months.”

“We’re not going to have one in early fall,” he said. “It’s going to take months.”

For an emergency use authorization, the “most likely” timing would be after a late-stage trial’s interim analysis shows safety and efficacy but before the developer can complete its full submission for approval, he added.

In the long run, there “may not be one winner” in the hunt for a COVID-19 vaccine. One vaccine might work in older adults, while another might perform better in younger people, Marks said.

That’s why the FDA is “strongly” encouraging companies to enroll a diverse group of trial participants, including racial and ethnic minorities, plus older adults and others, Marks said. The pandemic has disproportionately affected communities of color.

Citing the urgency, the agency is “poised to move review of any submissions” as quickly as possible, he added.

On the prospects of a “challenge trial,” where investigators would infect volunteers with COVID-19 to test a vaccine candidate’s ability to protect, Marks didn’t completely rule it out. There are ethical concerns because there isn’t a ready treatment for the novel coronavirus, but the FDA would consider such trials “based on protocol” and “given the circumstances,” Marks said.

Still, in his experience, volunteers might say they want to participate, but once the “rubber hits the road” they might change their minds.

Even as vaccines are still in development, experts have started to warn about the public’s willingness—or lack of willingness—to embrace a vaccine. About half of Americans said they planned to get a vaccine, according to a poll from late May.

The FDA’s “job number 1” is to fairly evaluate any programs that are submitted, he said. Also, communicating benefits and risks clearly is critical, he added.

https://www.fiercepharma.com/vaccines/as-covid-vaccines-race-ahead-fda-official-weighs-timelines-challenge-trials-and-more

Pfizer has a lot going on in immunology, but all its drugs could be beaten by rivals

Pfizer’s immunology portfolio includes the JAK inhibitor Xeljanz and a pipeline of five mid- to late-stage experimental drugs—a huge stable of assets that seems well-positioned to fuel strong growth over the next five years.

But one influential Wall Street firm took a deep dive into that immunology portfolio and found a troublesome undercurrent that made its analysts wonder just how much it will really contribute to Pfizer’s future growth.

Analysts at SVB Leerink warned clients in a note on Wednesday that “our review of the competitive landscape suggests Pfizer’s compounds could be beaten on speed to market, or better clinical data, in nearly all indications.”

One challenge is that Pfizer is heavily dependent on JAK inhibitors, SVB Leerink said. Xeljanz is approved to treat rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. Pfizer’s nearest-term prospect in its immunology portfolio is JAK inhibitor abrocitinib, which is in phase 3 trials to treat atopic dermatitis.

The SVB Leerink analysts expect abrocitinib to be bringing in $2 billion in sales by 2027. Another phase 3 JAK inhibitor, PF-06651600 for alopecia, should peak at $500 million a year, they added.

But abrocitinib will likely carry the Black Box warning that the FDA has slapped on the JAK class, which warns of a high risk of serious infections, cancer, blood clots and other issues. That warning “should relegate the drug to [second-line] behind Regeneron’s Dupixent until physicians gain experience and confidence in the product.”

Dupixent is far from the only rival drug that could pose challenges for Pfizer. AbbVie’s JAK inhibitor Rinvoq, approved to treat rheumatoid arthritis last year, could score a green light in atopic dermatitis before abrocitinib does, SVB Leerink analysts predicted. “In this situation, abrocitinib would not offer as much safety as Dupixent, or the efficacy of Rinvoq, and we’d expect it to struggle to gain market share,” they said.

Last month, AbbVie released clinical trial data showing that Rinvoq was better than placebo at producing a 75% drop in atopic dermatitis symptoms and clear or almost clear skin after 16 weeks. At the time, SVB Leerink predicted Rinvoq could become the standard of care for patients who don’t do well on Dupixent.

Pfizer has produced some positive data of its own, though it hasn’t yet been impressive enough to convince analysts that abrocitinib will shoot to the top of the competitive class of JAK inhibitors. Last October, Pfizer said the drug produced clear or almost clear skin in 43.8% of eczema patients participating in a phase 3 trial, versus 7.9% of those taking a placebo. More recently, Pfizer reported a statistically significant improvement in symptoms among teenagers in a phase 3 trial.

Pfizer is also testing a TYK2 inhibitor in psoriasis, but it’s facing stiff competition there, too. Bristol Myers Squibb is working on a TYK2 inhibitor, BMS-986165. SVB Leerink analysts pointed out that BMS recently posted clinical trial data suggesting its drug could offer double the effectiveness of Otezla, the drug BMS had to sell to Amgen in order to consummate its Celgene takeover. Add to that the fact that Pfizer is roughly two years behind BMS, and it’s hard to imagine it could make much of a mark in TYK2 inhibition, SVB Leerink said.

All in all, the analysts are projecting that Pfizer’s immunology sales will be flat this year and next at about $4.3 billion. From there, sales could grow 5% to 10% a year, they said—but only if the company’s JAK inhibitors are successful.

Ultimately, though, Pfizer may not be well-positioned to grab a significant piece of a rapidly growing market. “Global JAK inhibitor sales could grow from $2.7bn to $19.3bn with additional launches and indications,” SVB Leerink predicted, “but if it materializes, Pfizer might get only a small share.”

https://www.fiercepharma.com/pharma/pfizer-may-have-a-lot-going-immunology-but-all-its-drugs-could-be-beaten-by-rivals-analyst

Bayer reworks part of Roundup settlement after judge reluctant to OK

July 10, 2020

Bayer has taken its cue from a judge and decided to rework the portion of its proposed Roundup settlement that focuses on future lawsuits.

On Wednesday, Bayer said lawyers representing a class of plaintiffs who claim the Roundup weedkiller caused their cancer had withdrawn a request for court approval of that $1.25 billion section of the settlement deal.

“The withdrawal will enable the parties to more comprehensively address the questions” raised by Judge Vince Chhabria, the company said.

The decision came after Chhabria said he was “tentatively inclined” to reject Bayer’s plan for handling future claims. Bayer wanted to lump all potential claims into a new class bound by the $1.25 billion settlement. Under the proposal, Bayer would set up an independent panel of scientists to determine whether Roundup can cause cancer. If the panel didn’t find a causal relationship, no new cancer claims could be brought against the product.

However, Chhabria said he was skeptical about leaving that decision in the hands of scientists when it should be judges’ and juries’ responsibility. He also questioned whether it’s reasonable to bind all future plaintiffs to one finding when science keeps making new discoveries.

The withdrawal marks a setback in Bayer’s effort to solve once and for all the Roundup litigation headache it inherited from the Monsanto acquisition. It likely won’t affect the other part of the deal, worth up to $9.6 billion, that focuses on current plaintiffs.

“Bayer remains strongly committed to a resolution that simultaneously addresses both the current litigation on reasonable terms and a viable solution to manage and resolve potential future litigation,” the company said in a statement.

Now, it’s working with the plaintiffs on a plan B, and it might not take too long. “Although the Court is not aware of any Plan B, it would be surprising if none existed given the stakes involved and the novelty of Plan A,” Chhabria noted earlier.

https://www.fiercepharma.com/pharma/bayer-reworks-part-roundup-settlement-after-judge-s-reluctance-for-approval

Health insurers urge Congress to provide new funding for coverage amid pandemic

Health insurance companies are calling on Congress to provide more funding to help people keep coverage, citing the more than 44 million who have filed for unemployment since the coronavirus crisis started.

The two main health insurance lobbying groups, America’s Health Insurance Plans (AHIP) and the Blue Cross Blue Shield Association, wrote a letter to congressional leaders on Friday making a range of requests for the next coronavirus response package, expected later this month.

“The adoption of each of these recommendations is critical to assuring that health insurance providers are able to deliver coverage that is reliable and high value in all markets,” the letter states.

Health insurers have benefited financially from the cancellation of costly elective procedures during the coronavirus pandemic, which they have no longer had to pay for. They argue they are not asking for direct financial assistance for themselves, unlike many other industries, but for support to help people keep insurance. That assistance would eventually flow up to health insurers as well.

The recommendations include increasing government subsidies under the Affordable Care Act that help people afford their premiums, and providing financial assistance to employers to help them keep employer-sponsored health coverage for their workers.

A possibly more politically palatable recommendation, which is also included in the letter, is for the government to pick up the full cost to workers who lose their jobs through a program called COBRA. That program allows people who lose their jobs to keep the health insurance that the job provided, but it is usually very expensive for workers, unless the government steps in to pay the cost.

Discussions on that front have been complicated, however, by a partisan dispute in Congress over potential restrictions on funds going to plans that cover abortions.

Progressives such as Sen. Bernie Sanders (I-Vt.) have criticized the COBRA proposal. The move would allow “health insurance corporations [to] make massive profits off the plan,” Sanders wrote in a Politico op-ed in April.

Sanders and other progressives have instead proposed expanding government programs like Medicare to cover those who become uninsured due to the coronavirus economic crisis. But those proposals will go nowhere with Republicans, meaning COBRA has a better chance of the bipartisan support needed for passage.

On the key issue of coronavirus testing, insurers are calling for additional federal funding to cover testing and help workplaces and people go back to work. The Trump administration issued guidance last month saying that insurers do not have to cover surveillance testing at workplaces, a decision insurers support, but that congressional Democrats blasted as letting the companies off the hook and skirting the requirements Congress set in previous response packages.

In the letter Friday, insurers said Congress should provide additional funding to cover that testing.

“We know that Americans are anxious to maintain their health coverage, keep that coverage stable, ensure access to widespread and reliable testing, and ensure the resources needed to overcome COVID-19,” they said.

Asked whether insurers need action from Congress given their financial benefits from the cancellation of elective procedures, Kristine Grow, a spokeswoman for AHIP, wrote in an email that “it is too soon to know what the real financial impact of the virus will be.”

“We aren’t through this crisis yet,” she added. “And as elective and nonurgent procedures resume, those procedures must be paid for. It is possible that the care required will be more complex — and costly — because care and treatment were delayed.”

https://thehill.com/policy/healthcare/506766-health-insurers-call-on-congress-to-provide-new-funding-for-coverage-amid