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Wednesday, January 26, 2022

N95 distribution plan could imperil small US mask makers

 The Biden administration’s effort to distribute 400 million N95 masks for free dealt a blow to ailing American mask manufacturers that were just starting to see their sales recover during the recent omicron variant surge. 

Small U.S. mask makers saw their N95 sales decline by around 70 to 80 percent following President Biden’s mask announcement, potentially putting their operations at risk unless the federal government swiftly purchases more respirators, according to the American Mask Manufacturer’s Association (AMMA), their trade group. 

“We absolutely support that the Biden administration is helping get high-quality masks on people’s faces quickly, but there is an unintended consequence to that action and we’re hoping that it’s followed up with purchases based on President Biden’s Buy American order,” said Brent Dillie, the AMMA’s chairman and the commercial director of Virginia-based mask maker Premium-PPE. 

Most domestic mask makers launched at the onset of the pandemic to alleviate the nation’s mask shortage driven by China’s export restrictions.  

When companies, health care providers, schools and others were able to resume buying cheaper Chinese-made respirators — some of which failed to meet U.S. standards — demand for American-made masks plummeted, and U.S. manufacturers were forced to lay off thousands of workers. 

Some firms have survived by selling N95 respirators to individual customers. Sales exploded over the past six weeks as Americans became increasingly aware that cloth masks are not nearly as effective at stopping the omicron variant. However, companies say that the recent Biden announcement undercut that short-lived revenue bump. 

“I think we’re at a serious risk point that those manufacturers could largely disappear, and we would miss our opportunity to keep supply here of a critical national security item,” Dillie said.  

The federal government will begin distribution of N95 masks this week to counter sustained virus cases. They will come from the Strategic National Stockpile, which will have around 350 million respirators remaining. 

To replenish the stockpile, the Biden administration plans to order hundreds of millions of additional masks from domestic companies — a key opportunity that U.S. mask manufacturers have been waiting for — but some small operators worry that they will lose out to the largest manufacturers that can meet the federal government’s daunting production demands.  

Dawn O’Connell, assistant secretary for preparedness and response at the Department of Health and Human Services (HHS), told a Senate panel earlier this month that the agency wants to contract with domestic manufacturers that can produce 141 million N95 respirators per month.    

“We are in the process of putting out an agreement for warm-base manufacturing so we’re able to keep this capacity that we currently have going even when demand diminishes,” she told lawmakers. 

That’s the kind of long-term stability that American mask makers have been looking for.  

They’re currently reluctant to ramp up their production without knowing whether demand will keep up, and that uncertainty has made it challenging to hire and retain workers. 

But it’s likely that only the largest domestic manufacturers, like 3M Co. and Honeywell Inc., would be able to produce anywhere near that output. In a statement, 3M said that it has the capacity to manufacture approximately 100 million N95 respirators a month in its U.S. plants alone. 

Those companies are not members of the AMMA, which represents smaller U.S. firms. In total, the trade association’s 30 member companies can produce 70 million N95 masks each month without increasing their current capacity and staffing levels. 

“We will continue to assess the number of masks needed and replenish the stockpile accordingly — and as we do, we will continue to focus on domestically manufactured masks,” said HHS spokesperson Kirsten Allen. 

The AMMA is still hopeful that it can come to a deal with the Biden administration. The group argues that providing contracts to smaller U.S. mask makers aligns with Biden’s goal of using procurement to boost small business, promoting competition and buying American goods.  

Mask makers also stress that Americans need reliable protection from the fast-spreading omicron variant.

They point to a recent Centers for Disease Control and Prevention (CDC) report finding that 60 percent of Chinese-made KN95 masks failed to meet U.S. inspection requirements, making them less dependable than U.S. government-certified N95 respirators. 

Anne Miller, executive director of nonprofit group Project N95, said that the CDC finding makes clear that securing a reliable supply of N95 respirators is a “national health priority.” She said that the federal, state and local governments should only order U.S.-made N95s and that the U.S. should impose penalties on importers that make false claims about the quality of their masks. 

“As we know, we can expect future surges of COVID and because we want to be prepared it is essential that we prioritize the use of these masks as a matter of public health and national security policy,” Miller said. “This can be accomplished through a ‘carrot and stick’ approach of incentives for good masks and penalties for bad ones.”

American manufacturers have gotten a boost from lawmakers in both parties, who have consistently urged Biden to prioritize U.S.-made respirators. In a recent letter, Senate Democrats urged Biden to secure “long-term contracts for the purchase of masks made by American workers in the U.S. with U.S. materials.”

“We must not compromise the health of Americans by making purchases based mainly on lowest cost. Purchasing PPE made by American workers here in the U.S. supports domestic manufacturing and helps ensure a more reliable, consistent supply chain for these essential products,” the lawmakers, led by Sens. Tammy Baldwin (D-Wis.) and Sherrod Brown (D-Ohio), wrote in the letter.

https://thehill.com/business-a-lobbying/business-a-lobbying/591370-n95-distribution-plan-could-imperil-small-us-mask

HHS secretary under fire for being 'invisible' leader during pandemic

 Health and Human Services (HHS) Secretary Xavier Becerra is under fire for what critics say is a lack of leadership as the Biden administration wrestles with the direction of its COVID-19 response. 

Tasked with running the sprawling agency primarily responsible for responding to the COVID-19 pandemic as well as the day-to-day administration of the nation’s unwieldy health system, Becerra is supposed to corral the differing health factions into a unified message on the pandemic.

But outside health experts and former officials said he’s taken a back seat, ceding his authority to others, including the White House and the Centers for Disease Control and Prevention (CDC).

As administration health officials face criticism for confusing messages and guidance on topics ranging from masks to booster shots to isolation time, critics said there’s a lack of coordinated communication among public health agencies, and part of the problem is the low profile of the HHS secretary.

Public health messaging during a pandemic is complicated enough, but experts say the Biden administration as a whole needs to be better at making clear that the situation is evolving constantly.

“Of all the HHS secretaries we’ve had, at least in the last multiple administrations, we’ve never had one that was a ghost when it came to a public health crisis. That’s what we have now: an invisible HHS secretary. Just when we need that person the most,” said Eric Topol, director of the Scripps Research Translational Institute.

Becerra’s spokesperson, Sarah Lovenheim, the assistant secretary for public affairs, disputed the assertion that Becerra has not been a leader during the pandemic.

The secretary is “tackling a wealth of issues, with COVID being the focus,” Lovenheim said. “The secretary drives agency operations to support carrying out the mission, whether he’s coordinating our agencies to make booster doses accessible, authorizing the distribution of vaccines, or determining how to get masks in the hands of people in need of them.”

But the communication missteps have been unforced errors, experts said, reinforcing a perception that the administration is overly reactive and not proactive.

In the late summer and fall, disagreements over the administration’s plan for booster shots spilled over into the public. The White House announced a Sept. 20 deadline to get booster shots to every American, six months after their primary vaccine series. 

But the scientific agencies were not in alignment on the timing or the evidence. Even as the White House was pushing boosters for all, outside advisers to the CDC and Food and Drug Administration (FDA) were not convinced. 

Then, the CDC said people could get a booster if they wanted one; it wasn’t until the Friday before Thanksgiving and the identification and emergence of the omicron variant just a week later that the agency intensified the message to recommend every adult get a booster. 

Inside the White House, Jeff Zients is the administration’s coronavirus coordinator. He leads a team of medical experts including CDC Director Rochelle Walensky, White House medical adviser Anthony Fauci and former FDA Commissioner David Kessler, who is now chief science officer of the administration’s COVID-19 response team.

Becerra, who lacks experience as a public health communicator, is not part of that team. He is a former House member who also served as attorney general for California. During his confirmation hearing, Republicans attempted to paint Becerra as unqualified for the job for having no background as a health professional.

“I think HHS needs to step up more,” said Celine Gounder, an infectious disease specialist and epidemiologist at NYU and Bellevue Hospital.

“I think there is a need for perhaps better coordination because it can be confusing to the public if there seems to be different messages coming out as different agencies. How do you reconcile that and make sense of that? I think that is one of the things the HHS secretary should be doing,” Gounder added.

Lovenheim also provided a 13-page fact sheet detailing the agency’s accomplishments over the past year. The highlights include pandemic-focused efforts like investing in community health centers, education campaigns to build vaccine confidence and leading a health equity task force. The agency also promoted new investments in ObamaCare enrollment efforts, as well as regulatory protections for LGBTQ+ communities. 

There have, however, also been some very public missteps, and the CDC has borne the brunt of the criticism over confusing messages, something President Biden acknowledged during a press conference last week.

“The messages, to the extent they’ve been confusing — it’s because the scientists, they’re learning more,” Biden said.

Last year, the CDC took heavy criticism for issuing new mask guidelines for fully vaccinated people, only to reverse course as the delta variant spread.

Just after Christmas, the agency cut in half the recommended isolation period for someone who tests positive for COVID-19. The update came from a press release, with no accompanying data or media briefing.

Confusion and criticism ensued, as public experts said the agency erred by not specifying the need for a negative test before leaving isolation. Walensky and the administration spent the next week fielding criticism.

Tom Frieden, who ran the CDC under former President Obama, said HHS needs to stand up for the CDC, to insulate it from criticism.

“I think the lack of communication coming directly from CDC reflects a combination of the fact that the White House is not always comfortable with the policies that CDC is recommending and therefore isn’t comfortable with CDC speaking to the public,” Frieden said.

https://thehill.com/policy/healthcare/591374-hhs-secretary-under-fire-for-being-invisible-leader-during-pandemic

Thousands of LA-area law enforcement personnel out sick, quarantined ahead of Super Bowl

 COVID-19 has hit both the Los Angeles Police Department and the Los Angeles Sheriff's Department with around 2,500 personnel out sick or quarantining due to the coronavirus, The Los Angeles Times reported.

LAPD Chief Michel Moore told the newspaper that COVID-19 is having "a substantial impact on our deployment."

The high number of call outs comes just two weeks away from the Super Bowl, which is slated to be held in the city's SoFi Stadium.

Both the Los Angeles Police Department and the Los Angeles County Sheriff's Department have been impacted. The report said 1,300 LAPD staff and about 1,200 sheriff’s personnel are out sick.

Moore added that 83 percent of his staff is vaccinated but the LAPD is seeing a spike in breakthrough cases. The large increase in cases comes a week after Los Angeles surpassed 2 million COVID-19 cases throughout the pandemic. 

"What we're following very closely is this impact on our deployment numbers as we approach the Super Bowl week of celebration and events here," he said according to the Times.  

 

He said the LAPD is "looking at contingency planning" for staffing the events the week of the Super Bowl. 

The surge in cases also reflects a wider citywide spike in coronavirus cases.

COVID-19 cases in the Los Angeles area are almost 10 times higher than they were one month ago as the omicron variant spreads rapidly.

The county has also reported an uptick in COVID-19 deaths, with daily fatalities resulting from the virus doubling in just one week. On Thursday, the county reported 102 COVID-19 deaths, marking the most fatalities it has seen in a day since March 10, 2021, according to the county’s public health department.

https://thehill.com/homenews/state-watch/591409-thousands-of-la-area-law-enforcement-personnel-out-sick-quarantined

NRx Gets Initial Report of Patient Safety and Survival from Right to Try use of ZYESAMI during Omicron Surge

 A Southwestern hospital has reported safety data collected under the Federal Right to Try law indicating that 16 of 19 patients (84%) with COVID-19 respiratory failure treated with ZYESAMI® by Dec 31, 2021 have survived the ICU.

-No Serious Adverse Events were reported

-Patients were treated during the Omicron Surge

-Patients were treated at first onset of respiratory failure after exhausting remdesivir and other approved therapies

-Data are being included provided by NRx to FDA in support of ongoing application to FDA for Emergency Use Authorization

https://finance.yahoo.com/news/nrx-receives-initial-report-patient-115100026.html

Quest Diagnostics Launches COVID-19 Rapid Antigen Test with Observed Collection for Consumers

 Individuals may perform test in minutes in the comfort of their home, at their convenience

Features proctored telehealth visit via eMed™ to help individuals meet travel and other observed collection and test report requirements

https://finance.yahoo.com/news/quest-diagnostics-launches-covid-19-120000102.html

Evolus: Prelim Revenue and 2022 Guidanc

 Q4 2021 Preliminary Unaudited Net Revenue of Approximately $34.7 Million, Up 68% from Q4 2020

• Full-Year 2021 Preliminary Unaudited Net Revenue of Approximately $99.7 Million, Up 76% Over 2020

• 2022 Net Revenue Expected to be $143 to $150 Million Representing 43% to 50% Growth

• Cash Position (Unaudited) at December 31, 2021 of Approximately $146.3 Million

https://finance.yahoo.com/news/evolus-announces-preliminary-unaudited-fourth-134500854.html

Vaccinex: Positive Responses in Phase 1b/2 Study of Cancer Combo

 Vaccinex, Inc. (Nasdaq: VCNX, Vaccinex, the Company), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of semaphorin 4D (SEMA4D), today reported positive interim response data in the Phase Ib segment of the KEYNOTE-B84 study of Vaccinex’s pepinemab in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Among the three patients enrolled in the Phase1b safety segment of the study, two patients have been observed to experience a complete response (CR), as per RECIST v.1.1. Biomarker analysis revealed that tumors in both responders expressed low levels of PD-L1 biomarker (CPS<20), a subset of HNSCC patients who have historically low response rates to anti-PD-1/L1 antibodies administered as single agents.

https://finance.yahoo.com/news/vaccinex-reports-two-complete-responses-130000113.html