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Thursday, October 7, 2021

Nordic Countries Suspend Use of Moderna Covid-19 Vaccine in Young People

 Finland on Thursday joined Nordic neighbors Sweden and Denmark in suspending use of Moderna Inc.'s Covid-19 vaccine in young people after reports of an increased risk of heart inflammation.

Finland's Institute for Health and Welfare said it will pause use of Moderna's vaccine for men under the age of 30, adopting a similar stance to other Nordic nations over concerns that the vaccine increases inflammation of both the heart muscle and the membrane that surrounds the heart.

The move comes after Denmark said Wednesday that it wouldn't offer under 18s the Moderna vaccine as a precautionary measure, while Sweden's Public Health Agency also said Wednesday it had paused use of the vaccine for everyone born in 1991 and later.

Swedish authorities said data point to an increased incidence of cardiovascular conditions in boys and young men especially, so they will suspend use of the vaccine until Dec. 1, when an update will be provided.

"New preliminary analyzes from Swedish and Nordic data sources indicate that the connection is especially clear when it comes to Moderna's vaccine Spikevax, especially after the second dose," the Swedish Public Health Agency said.

"The increase in risk is seen within four weeks after the vaccination, mainly within the first two weeks."

Norway also said yesterday that it recommends young people under the age of 18 avoid being jabbed with Moderna's vaccine.

"Men under the age of 30 should also consider choosing [BioNTech/Pfizer's] Comirnaty when they are to be vaccinated," said Geir Bukholm, deputy director general at the Norwegian Institute of Public Health.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Nordic-Countries-Suspend-Use-of-Moderna-Covid-19-Vaccine-in-Young-People-36624145/

Bristol Myers misses endpoints in Phase 2 ulcerative colitis trial

 LATTICE-UC proof of concept study did not meet primary nor secondary endpoints

Safety profile of deucravacitinib consistent with other trials and no new safety signals reported

Bristol Myers Squibb (NYSE: BMY) today announced the Phase 2 LATTICE-UC study evaluating deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, compared to placebo in moderate to severe ulcerative colitis (UC) did not meet the primary efficacy endpoint of clinical remission at Week 12, nor secondary efficacy endpoints. The safety profile of deucravacitinib was consistent with previously reported studies in psoriasis and psoriatic arthritis, and no new safety signals were observed.

"Deucravacitinib has been shown to be a highly effective, first-in-class, oral, selective TYK2 inhibitor in psoriasis and we have ongoing Phase 3 trials exploring the potential of deucravacitinib in psoriatic arthritis," said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. "While we did not achieve proof of concept in this study, we are committed to advancing our deucravacitinib clinical program in inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as in psoriatic arthritis, lupus and other immune-mediated diseases. Bristol Myers Squibb would like to thank the patients and investigators who were involved in the LATTICE-UC clinical trial."

The company will complete a full review of the data from LATTICE-UC and the potential of deucravacitinib in UC continues to be evaluated in IM011-127, a second Phase 2 trial that also includes a higher dose.

Bristol Myers Squibb continues to expect greater than $4 billion non-risk adjusted revenue target for deucravacitinib in 2029.

https://finance.yahoo.com/news/bristol-myers-squibb-provides-phase-105900443.html

Brickell hits all endpoints in Phase 3 Hyperhidrosis Trial

 Sofpironium bromide gel, 15% was generally well-tolerated

Plan to submit a New Drug Application (NDA) to the FDA in mid-2022

Management to host webcast and conference call today at 8:30 a.m. ET to present the topline results

Conference Call and Webcast Information

Brickell’s management will host a webcast and conference call today at 8:30 a.m. ET to discuss the topline data announced in this release. The dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13723931. A live webcast of the conference call can be accessed here or through the “Investors” tab on the Brickell Biotech website at https://www.brickellbio.com. A replay will be available on this website shortly after conclusion of the event for approximately 90 days.

https://finance.yahoo.com/news/brickell-biotech-announces-positive-topline-105500385.html

Cytokinetics started at Buy by Jefferies

 Target $75

https://finviz.com/quote.ashx?t=CYTK

Wednesday, October 6, 2021

Patients left in lurch as NY’s home-care workers face vaccine deadline

 Thousands of homebound patients across New York state could be left without the care they need as at-home health care workers stare down governor Kathy Hochul’s Thursday deadline for them to get vaccinated, according to industry insiders.

As many as 50,000 home health aides across the state who have yet to be vaccinated could lose their jobs or be put on leave Thursday, Artie Schwabe, CEO and co-founder of Premier Home Health Care, told The Post.

If at-home health care agencies are required to fire unvaccinated workers, patients will likely lose care, as companies like his won’t be able to quickly find replacements due to a labor shortage that’s hit health care particularly hard, he said.

Premier Home Health Care has tried to incentivize workers to get the shots, Schwabe said, and the company’s vaccination rate is up to 90 percent.

But the industry needs more time to make sure vulnerable patients don’t fall through the cracks, he said, adding that he’s looking into filing for a temporary restraining order to block the mandate.

The figure of 50,000 unvaccinated home-care workers across the state sounds right to Kathy Febraio, CEO and President of the New York State Association of Health Care Providers, a trade association that represents the home-care industry.

She said home-care staffing agencies are “prioritizing their highest-risk patients” and “shifting caseloads to accommodate as many of their patients as possible.”

“But we are watching the clock closely,” she added.

Home-care staff are going to have to work overtime to cover patients if the state refuses to budge on Thursday deadline, she said, “but they’ve already been working overtime throughout this pandemic.”

“They are tired. They are overwhelmed, and we need some relief,” she said, adding that home-care workers have been leaving their jobs in large numbers during the pandemic and she’s concerned the vaccine mandate will only hurt the workforce more.

A similar vaccination mandate for health care workers in congregate settings like hospitals took effect last month has led to some sweeping dismissals and suspensions.

Despite the firings, Hochul has said she won’t budge on the issue.

And unlike hospital workers, Febraio noted, home-care workers don’t necessarily report to an office everyday, adding a logistical challenge to even gathering the proof of vaccination.

Al Cardillo, the president of the Home Care Association of New York, said the number of unvaccinated home-care workers who lose their jobs on Thursday could in fact be greater than 50,000.

Surveys done by his group suggest that some 70,000 home-care aides could be unvaccinated, on top of another 6,000 nurses.

The governor’s inflexible deadline, he said, is “not responsible.”

“The big issue is not the mandate,” he said. “The issue is the question of applying the mandate.”

The state has created an “an all-or-nothing scenario,” he said, adding that the governor is telling elderly and vulnerable people, “Good luck on your services.”

Cardillo as well as everyone The Post spoke with for this story said they are in favor of encouraging vaccinations, but he urged the governor to reconsider the deadline.

In response to his and others’ pleas to address the impending worker shortage, he said the state has loosened regulations so that companies can tap out-of-state home-care aides and even military members to fill gaps.

But if thousands of workers are fired on Thursday, Cardillo said replacements almost certainly won’t be there on Friday.

When reached for comment, Hochul’s office referred The Post to the Department of Health.

“It is critical for health care workers to get vaccinated to protect themselves and the vulnerable populations they care for, and we will continue to work with providers and stakeholders to protect quality patient care,” DOH spokeswoman Jill Montag said. 

“We are encouraged by the increase in hospital and nursing home staff who got vaccinated in the weeks and days leading up to their vaccine mandate deadline and we expect the same of those health care workers who will be required to receive at least one vaccine dose by October 7.”

https://nypost.com/2021/10/06/patients-left-in-lurch-as-nys-home-care-workers-face-vaccine-deadline/

NY nursing homes unable to get staff from state hotline after vax mandate

 Nursing homes desperately seeking relief from staffing shortages tied to New York’s new COVID-19 vaccine mandate are being told “we do not have any staff to offer you or any other nursing homes” upon calling the hotline specifically set up to help plug vacancies, The Post has learned.

“Despite what the media says, currently, we do not have any staff to offer you or any other nursing homes. I will log you in our system,” a state Department of Health staffer manning the agency’s “Surge and Flex Operations Center” hotline told one nursing home, when they asked about getting reinforcements on Oct. 4 — just one week after the mandate’s effective date. 

“Feel free to call with updates, but no need to call daily hoping this will be your lucky day,” the operator told the disappointed nursing home, which wished to remain anonymous. 

Callers receive an “intake number” and assigned a case, which is then reviewed by the state and severity of need is assessed, according to a source familiar with the hotline.

The stark reality contradicts Gov. Kathy Hochul’s public statements since the mandate took effect Sept. 27, as well as an executive order she signed declaring there’s a reserve of healthcare employees ready to backfill positions following resignations or terminations. 

The mandate requires all healthcare workers in healthcare facilities to be vaccinated from the deadly virus — unless they have an approved medical exemption — or else employers can fire them

Another nursing home industry source reached out on Sept. 29 to the hotline who was told “they do not have any staff.” 

“They are aware that it was mentioned in the news regarding vaccine mandate staffing issues,” wrote the source, according to internal communications obtained by The Post.

But Hochul dug in during a Tuesday press conference when probed about the state’s refusal to release data pertaining to worker shortages in nursing homes or hospitals, which are required to be reported to the DOH in daily surveys.

She argued healthcare facilities should call the DOH’s “24/7 operations center” to request staff and may even have access to student nurses. In the worst case scenario the National Guard could be deployed, although the state has not done so.

“We set up a system to be responsive to any institution that needed help,” Hochul told reporters in Albany Tuesday. 

“We set up all these opportunities, whether it was using student nurses, whether people with licenses had lapsed, whether or not someone would be coming in from another state…and so we’ve reached out. We offered help. Very few have taken [us] up on it, because they are also required to have their own emergency staffing plans themselves,” said Hochul. 

A DOH rep told The Post that since last Monday, the agency has received “nearly 50 calls” related to staffing requests. The rep would not say whether or not any healthcare staff were actually deployed to facilities, instead saying “the Department is advising facilities on internal steps they can take to address staff shortages, as well as ways to take advantage of the Executive Order.”

But the statewide vaccination rate of elder care staffers with at least one shot has increased to 97 percent statewide according to the latest DOH data. It’s up from 92 percent of staffers on the day the mandate was announced.

The statewide vaccination rate of elder care staffers with at least one shot is 97 percent, according to the latest DOH data, up from 92 percent of staffers on the day the mandate was announced. 

Although elder care facility residents and staff were first in line last December to get shots, efforts to boost vaccination rates have been met with resistance.

Nursing homes could be on track to lose more staffers within the coming week tied to a pending federal court case, where a judge is anticipated to rule on or before Oct. 12 whether or not employers may deny requests for religious exemptions from getting the shot.

But nursing homes could be on track to lose more staffers within the coming week tied to a pending federal court case, where a judge is anticipated to rule on or before Oct. 12 whether or not employers may deny requests for religious exemptions from getting the shot.

Hochul has said she is confident the mandate will be upheld in court.

The DOH confirmed to The Post Wednesday that just 2,934 workers — or 2.1 percent of 140,917 total employees statewide — have “claimed another exemption, which is the subject of pending litigation” — a nod to the total number of religious exemptions submitted. 

Another 674 statewide — 0.5 percent of staffers — have been granted medical exemptions.

For hospitals, 7,019 employees — 1.4 percent of around 521,000 employees statewide — have claimed “another exemption,” and 2,607 workers — or .06 percent — have been granted medical exemptions.

The DOH confirmed to The Post that 2,934 workers have “claimed another exemption, which is the subject of pending litigation” — a nod to the total number of religious exemptions submitted. 

Another 674 statewide have been granted medical exemptions.

There are 613 nursing homes in New York and roughly 145,408 employees, according to the DOH on Sept. 23 — but it is unclear how many workers have been fired or resigned because they refused to get vaccinated.

“They talked about calling up the national guard and importing nurses from out of state and out of country and now when the facilities say ‘we are ready to use those people,’ the state says, ‘we don’t have any,’” said Bill Hammond, the Empire Center’s senior fellow for health policy. 

One nursing home industry source told The Post: “We’ve told [nursing homes] we’re not confident that staff would actually be available because our past history throughout the pandemic has been just that.” 

“The state’s volunteer corps or hotline has not been able to provide help to long term care providers…You are more likely to get a survey team sent to your facility rather than new staff,” said the source, noting the DOH would probably send a group of agency inspectors to assess current staffing and safety protocols,” the source added.

Since the pandemic’s start in March 2020, over 15,000 nursing home residents have died from the virus.

Disgraced ex-Gov. Andrew Cuomo’s administration refused to release data pertaining to the true number of deaths tied to the virus for months, until a state judge forced the DOH to release statistics. 

Cuomo’s former top aide then admitted they “froze” and were worried about retribution from the Trump administration if they released the data. 

The FBI and Eastern District of New York launched an investigation into the matter shortly after and are apparently still probing the issue. 

https://nypost.com/2021/10/06/ny-nursing-homes-cant-get-staff-from-state-hotline-following-vax-mandate/

Colorado hospital system denies organ transplants to unvaccinated patients

 A Colorado hospital system says it is denying organ transplants to patients who haven’t been vaccinated against COVID-19 “in almost all situations” under a new policy.

UCHealth, which operates hospitals and urgent care facilities throughout the state, confirmed to The Post on Wednesday that organ transplant recipients and living donors must now be vaccinated against COVID-19 before undergoing procedures.

The health system said the driving force behind the policy change was studies showing transplant patients are more likely to die if they contract COVID-19. The mortality rate for transplant patients who get COVID is more than 20 percent, according to UCHealth.

“This is why it is essential that both the recipient and the living donor be vaccinated and take other precautions prior to undergoing transplant surgery,” UCHealth said in a statement.

“Surgeries may be postponed until patients take all required precautions in order to give them the best chance at positive outcomes.”

It wasn’t immediately clear when the new policy was put in place or what situations did not warrant a COVID vaccine.

UCHealth confirmed the policy change after Republican Colorado state Rep. Tim Geitner on Tuesday tweeted out a letter that Colorado Springs woman Leilani Lutali received last month, saying her waiting list status for her kidney transplant had been changed to “inactive” because she hadn’t been vaccinated.

In an interview with CBS Denver, Lutali said her donor, Jaimee Fougner — whom she met in Bible study 10 months ago — also hadn’t been vaccinated.

Lutali, who has stage 5 renal failure, said she was informed of the new policy in a Sept. 28 letter after initially being told in August she didn’t need to have the vaccine to get her new kidney.

She said she doesn’t want to get the vaccine because there are too many unknowns.

“I said I’ll sign a medical waiver. I have to sign a waiver anyway for the transplant itself, releasing them from anything that could possibly go wrong,” Lutali said.

“It’s surgery, it’s invasive. I sign a waiver for my life. I’m not sure why I can’t sign a waiver for the COVID shot.”

Fougner, who said she hasn’t received the shot for religious reasons, added: “It’s your choice on what treatment you have. In Leilani’s case, the choice has been taken from her. Her life has now been held hostage because of this mandate.”

The pair are looking for another hospital to carry out the transplant.

UCHealth doubled down on its new policy, saying other transplant centers across the country already have COVID vaccine mandates in place and others are introducing it now.

“An organ transplant is a unique surgery that leads to a lifetime of specialized management to ensure an organ is not rejected, which can lead to serious complications, the need for a subsequent transplant surgery, or even death,” UCHealth said in a statement.  

“Physicians must consider the short and long-term health risks for patients as they consider whether to recommend an organ transplant.”

UCHealth said there are specific requirements in place prior to transplants taking place. In some instances, patients are required to have other vaccinations, such as hepatitis B, or may be required to avoid alcohol, smoking or prove they can continue taking anti-rejection medications.

“These requirements increase the likelihood that a transplant will be successful and the patient will avoid rejection,” the statement said.

“In almost all situations, transplant recipients and living donors at UCHealth are now required to be vaccinated against COVID-19 in addition to meeting other health requirements and receiving additional vaccinations.”

https://nypost.com/2021/10/06/colorado-hospitals-deny-organ-transplants-to-unvaccinated/