U.S. to require nursing homes get staff fully vaccinated or lose federal funding

 President Joe Biden on Wednesday announced his administration will require all employees in nursing homes to get vaccinated for Covid-19, the latest effort to protect Americans as the delta variant spreads. 

“Today I’m announcing a new step,” Biden said in a speech at the White House. “If you work in a nursing home and serve people on Medicare or Medicaid, you will also be required to get vaccinated.”

Biden’s remarks came after an administration official confirmed to NBC News that the government will withhold federal funding from nursing homes that fail to fully vaccinate their staff.

The new policy, which would withhold Medicare and Medicaid funding to nursing homes that don’t comply, could take effect as early as next month, the official said, though the timing is fluid. It would impact about 15,000 nursing homes, which employ more than 1.3 million people nationwide.

The move comes as the highly contagious delta variant drives a surge in new cases nationwide, and federal officials say they are starting to see evidence of waning vaccine protection against mild and moderate disease.

Nationally, about 60% of nursing home staff are vaccinated – much lower than the 82.4% of residents who have gotten the shots, according to data compiled by Centers for Medicare & Medicaid Services. In some states, the percentage of nursing home staff who are vaccinated is even lower.

Some medical experts have asked the U.S. government to pressure nursing homes to vaccinate their staff, saying the unvaccinated employees put older residents – who are more likely to get severely ill or suffer from a so-called breakthrough infection – at greater risk.

“We need to go faster. That’s why I’m taking steps on vaccination requirements where I can,” Biden said in the speech.

The new rules for nursing homes are “all about keeping people safe and out of harm’s way,” he said.

“This is no time to let our guard down. We just need to finish the job, with science, with facts and with confidence,” the president said.

Earlier in the day, federal health officials announced they plan to make booster shots available to most Americans beginning the week of Sept. 20. They said it is “very clear” that immunity starts to fall after the initial two doses, and with the dominance of the delta variant, “we are starting to see evidence of reduced protection against mild and moderate disease.”

“Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout,” according to the statement signed by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other U.S. health leaders.

Nursing home residents, health-care providers and the elderly — the first groups to get vaccinated in December and January — are likely to be prioritized to get extra shots, according to National Institutes of Health Director Dr. Francis Collins.

https://www.cnbc.com/2021/08/18/covid-vaccine-us-to-require-nursing-homes-staff-get-shots-or-lose-government-funding.html

94% of Adults in England Have Covid-19 Antibodies

 A staggering 94.2% of adults in England have antibodies for covid-19, according to a new report from the UK’s Office of National Statistics. Roughly 80.7% of England’s population has been fully vaccinated, suggesting the rest of the 94.2% acquired antibodies through natural infection with the coronavirus.

The report is great news for England, which has seen covid-19 rates plateau at roughly 25,000 per day. Deaths have remained extremely low, with a seven-day average of 81 covid-19 fatalities daily.

The UK more broadly has also seen a rise in antibodies among adults, with 93.2% in Wales, 89.1% in Northern Ireland and 93.5% in Scotland, according to the Office of National Statistics. Again, part of that is from high rates of vaccination and part of that is through natural infection.

The UK was one of the hardest hit regions for covid-19 with over 6.36 million cases and more than 131,000 deaths since the start of the pandemic.

The new report out of the UK should lift plenty of spirits for people who want to get the covid-19 pandemic behind them. Though admittedly, England has been wide open ever since it’s “Freedom Day” on July 19.

“Across the four UK countries, the estimated percentage of adults aged 25 to 34 years who have received one or more doses of a COVID-19 vaccine ranged from 82.3% to 90.1% – this has increased sharply since the end of May,” the Office of National Statistics said in a statement early Thursday.

“A similar increase can be seen for those aged 16 to 24 years across the UK since June, with between 51.3% and 56.6% reporting having had at least one dose of a COVID-19 vaccine in the week beginning 26 July 2021,” the statement continued.

The Moderna vaccine was approved in the UK for children as young as 12 years old just this week, while the Pfizer vaccine was approved for that age group a few weeks ago. Children under 12 are still not eligible for any covid-19 vaccine in the UK, just as they aren’t in the U.S. yet either.

Most adults in the UK were vaccinated with the AstraZeneca vaccine, which relies on older vaccine technology that doesn’t include Pfizer and Moderna’s mRNA platform. But that will be fine for British adults in the long run, since a new study has shown that while Pfizer worked better than AstraZeneca for a few weeks, Pfizer’s efficacy wanes over time and they both work about the same, according to the BBC.

To be clear, every vaccine approved by the FDA has been shown to be effective against covid-19, even the highly contagious delta variant of the virus. So if you haven’t gotten vaccinated yet, please make that happen as soon as possible. You don’t want to regret going without the vaccine, as so many people are learning the hard way around the world.

https://gizmodo.com/whopping-94-of-adults-in-england-have-covid-19-antibod-1847515379

More Teens Trying to Quit Vaping Than Ever Before

 More than half (53.4%) of adolescents in the U.S. who reported current e-cigarette use said they intended to quit, and two-thirds recounted past-year attempts to quit, according to a national study.

Using data from the 2020 National Youth Tobacco Survey (NYTS) -- which produced 1,660 respondents ages 11 to 18 in the study's final analytical sample -- researchers found that intention to quit was lower among girls versus boys (adjusted OR [aOR] 0.7, P=0.0004), in users of modifiable vapes versus disposable e-cigarettes (aOR 0.4, P=0.0204), and in those who used other tobacco products in tandem with their e-cigarettes versus sole e-cigarette users (aOR 0.7, P=0.0144), reported Hongying Dai, PhD, of the University of Nebraska Medical Center in Omaha.

However, E-cigarette harm perception was positively associated with both intention to quit (aOR 2.2, P<0.0001) and past-year attempts to quit (aOR 1.6, P=0.0037), Dai noted in Pediatrics.

Reasons for vaping were related to cessation behaviors, she explained. Teens who started using e-cigarettes out of curiosity had higher odds of a past-year attempt to quit (aOR 1.4, P=0.0306). On the other hand, those who used e-cigarettes to disguise their use were less likely to report both intention to quit (aOR 0.4, P<0.0001) and past-year quit attempts (aOR 0.7, P=0.0126).

On average, the number of past-year quitting attempts was 5.3; this number was lower for girls and young women, users of a refillable device such as JUUL, and those who reported experiencing nicotine cravings.

The number of adolescents in the U.S. who reported intention or past-year attempts to quit vaping in this study was significantly higher than a previous assessment, which used 2017 Population Assessment on Tobacco and Health (PATH) data and found that 44.5% of middle and high schoolers were seriously considering quitting and 24.9% made past-year quit attempts.

While Dai noted that this difference may be due in part to the location of the surveys -- NYTS is school-based, while PATH is home-based -- and variations in question phrasing, she also pointed out that the constantly changing e-cigarette market likely played its own role. For example, she wrote, the widespread media coverage on vaping risks in 2019 following reports of lung injuries may have had an impact on adolescents' attitudes towards e-cigarettes.

Additionally, since 2017, there has been a growing body of research detailing the adverse health effects of adolescent e-cigarette use disseminated through social media and news outlets. New legislation -- such as Tobacco 21, which has made it harder for those under 21 to buy tobacco and nicotine products -- has also likely contributed to cessation behaviors.

"The findings from this study may inform the development of future evidence-based vaping cessation interventions," Dai wrote. "Perceived harm of e-cigarette use is strongly associated with both intention to quit vaping and past-year quit attempts. As shown in the previous qualitative studies, health effect is one of the top reasons for adolescents to quit vaping."

Along these lines, this study found that students who had heard of the FDA's anti-vaping campaign, "The Real Cost," had a higher prevalence of intention to quit vaping.

Still, Dai said, the high percentage (44.5%) of current e-cigarette users that don't understand the full impact that vaping can have on health outcomes is cause for alarm. She pointed out the possible link between refillable vapes being exempt from the flavor ban in 2020 and the fact that those who used such modifiable systems had a lower prevalence of intention to quit.

"Vaping products with a modifiable system allow users to customize voltage, temperature, and electronic liquids, tending to deliver nicotine to the lungs more efficiently," she noted. "These features may increase the appeal and nicotine uptake from vaping."

Dai acknowledged that the study's self-report design does pose a significant limitation to her findings, as the self-reporting of intention to quit and past-year attempts may be subject to recall and social desirability biases. In addition, the definition of past-year quit attempts -- requiring at least 1 day of attempting to quit -- may inflate the number of true quit attempts, since those who only dabble in e-cigarette use may go days without vaping.

Disclosures

This study was supported by funding from the University of Nebraska Medical Center's College of Public Health Innovation Fund and the University of Nebraska Collaboration Initiative Planning Grant.

Dai reported no conflicts of interest.

Primary Source

Pediatrics

Source Reference: Dai H, "Prevalence and factors associated with youth vaping cessation intention and quit attempts" Pediatrics 2021; DOI: 10.1542/peds.2021-050164.

https://www.medpagetoday.com/pulmonology/smoking/94096

Tori’s lung cancer hit raises a key question

Shanghai Junshi and Coherus celebrating the success of their anti-PD-1 MAb toripalimab in first-line lung cancer yesterday raises a key question: will the FDA approve a drug on the basis of a trial run entirely in China?

The tori study in question, Choice-01, was run in just one Chinese hospital, and the question is relevant not only because Chinese and US patients might exhibit different characteristics, but also because Choice-01 did not offer control subjects a key US standard of care, Merck & Co’s Keytruda. An answer might soon come from a separate tori filing, and will surely have a political dimension given Coherus’s low-cost strategy.

There will be some agitating for tori to be approved as quickly as possible in the US: Coherus is one company that has a stated mission of launching “cost-effective medicines ... to deliver significant savings”. This is especially apt in immuno-oncology, whose tally of US-approved anti-PD-(L)1 drugs is seven and counting.

US approvable?

Still, it is not at all clear that Choice-01 is a US-approvable study, as according to clinicaltrials.gov it was conducted at a single Chinese centre, the Cancer Hospital Chinese Academy of Medical Sciences in Beijing.

Toripalimab met its primary endpoint, increasing median progression-free survival to 8.3 months, versus 5.6 for chemo, with a highly statistically significant 41% reduction in risk of progression across all-comers. But if chemo is an appropriate comparator in China, where Keytruda might not yet be established as first-line standard, this is not the case in the US.

Indeed, it would be very difficult ethically to run a US trial in which control cohort subjects were denied Keytruda, and some say this fact justifies carrying out such studies elsewhere. Nevertheless, Choice-01 does not appear to reflect a US patient’s reality.

Coherus bulls will now look for a precedent. One exists with Sanofi/Regeneron’s latecomer Libtayo, which got US approval this year in first-line ≥50% PD-L1-expressing NSCLC on the strength of a study run largely in Asia, east Europe and South America.

And earlier this month Beyondspring argued that the FDA was amenable to a US filing based on a study that comprised only 20% recruitment in the US, as long as pharmacokinetic data for US and Asia patients were similar.

Where this leaves another two metastatic NSCLC laggards, Astrazeneca’s Imfinzi and Merck KGaA/Pfizer’s Bavencio, is a separate question. Both are in pivotal first-line NSCLC trials that do include the US, but which have been extensively redesigned, upsized and delayed. Perhaps the increasing use of Keytruda is playing havoc here, but in any case their chances of success seem low.

Selected trials of anti-PD-(L)1 MAbs in 1st-line NSCLC
Product	Company	Study	Regional scope	Primary endpoint(s)/result	US outcome
Keytruda	Merck & Co	Keynote-042	Global, incl US	Positive for mOS vs chemo in PD-L1 ≥1%*	Approved for PD-L1 ≥1%
Tecentriq	Roche	Impower-110	Global, incl US	Positive for mOS vs chemo in PD-L1 ≥50%**	Approved for PD-L1 ≥50%
Libtayo	Sanofi/Regeneron	Empower-Lung 1	Australia, Asia, east Europe & S America	Positive for mOS & mPFS vs chemo in PD-L1 ≥50%	Approved for PD-L1 ≥50%
Tuoyi (toripalimab)	Shanghai Junshi/Coherus	Choice-01	China	mPFS 8.3mth vs 5.6mth for chemo (HR=0.58, p=0.0001) in all-comers	NA
Bavencio	Merck KGaA/Pfizer	Javelin Lung 100	Global, incl US	PFS & OS in PD-L1 expressers; completion Oct 2021^	NA
Imfinzi	Astrazeneca	Pearl	Australia, Asia, east Europe & US (1 centre)	OS in PD-L1 ≥25%; completion Oct 2021, data H1 2022^^	NA
Notes: *failed secondary mPFS endpoint; **positive for secondary mPFS endpoint; ^completion was originally Apr 2019, and all-comers PFS was original sole primary endpoint; ^^completion was originally Jul 2020, and PFS was a co-primary endpoint. Source: clinicaltrials.gov & company statements.

Tori, which is already approved in China as Tuoyi, will itself give a big clue to the FDA’s thinking when the US regulator reviews its expected BLA for nasopharyngeal carcinoma – backed by the Asian Polaris-02 and Jupiter-02 trials.

Before that bulls will point at the high quality of the Choice-01 data, which appear to back tori irrespective of patients' PD-L1 expression. Keytruda monotherapy is approved in PD-L1 ≥1% expressers, and as part of a chemo combo in all-comers, while the other front-line US monotherapy player, Roche’s Tecentriq, has a ≥50% PD-L1 expression stipulation.

So another question for tori is how it performed in PD-L1-negative subjects, since it is possible that its all-comers benefit was simply driven by expressers. Investors do not have long to wait: Choice-01 data are to be presented in full at next month’s World Lung conference.

https://www.evaluate.com/vantage/articles/news/trial-results/toris-lung-cancer-hit-raises-key-question

Inovalon to Be Acquired by Equity Consortium for $7.3B

  Inovalon (Nasdaq: INOV), a leading provider of cloud-based platforms empowering data-driven healthcare, today announced that it has entered into a definitive agreement to be acquired by an equity consortium led by Nordic Capital, and joined by Insight Partners, as lead co-investor, 22C Capital, and Inovalon founder and Chief Executive Officer Keith Dunleavy, M.D. and certain Class B stockholders of Inovalon in an all-cash transaction with an enterprise value of approximately $7.3 billion.

Under the terms of the agreement, Inovalon stockholders will receive $41.00 per share in cash for each share of Class A Common Stock or Class B Common Stock, representing a 25.3% premium over the closing price of Inovalon Class A Common Stock on July 26, 2021, the last unaffected trading day prior to media speculation regarding a potential transaction, and a 24.4% premium over the volume-weighted average price of the Company’s shares over the 30 trading days leading up to the unaffected trading day.

The independent members of the Inovalon Board of Directors, acting on the unanimous recommendation of a special committee of independent directors that led the consideration of alternatives and the negotiation of the terms of the transaction, unanimously approved the agreement, which is subject to a number of customary conditions, including a vote of each of the Class A and Class B stockholders voting separately. In addition, the transaction is subject to approval by a majority of the voting power of the Class A and Class B stockholders voting together as a single class, excluding Dr. Dunleavy, certain other Class B stockholders who are providing equity capital for the transaction and their affiliates. Dr. Dunleavy was not a member of the Special Committee and recused himself from all relevant Board discussions and from the Board vote regarding the transaction.

Upon completion of the transaction, Inovalon will become a private company with greater flexibility to focus on strategies that drive innovation and global market development. Keith Dunleavy, M.D., will continue to be a substantial shareholder in the Company, serve on the Board of Directors, lead Inovalon as CEO, and the Company will maintain its headquarters in Bowie, Maryland.

https://finance.yahoo.com/news/inovalon-acquired-equity-consortium-led-120000141.html

Sonoma Pharma Expands Dental Care Line

 Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound, eye, oral and nasal care, disinfectant use and dermatological conditions, today announced that it has launched two new dental products. OroGenix Oral Hygiene Rinse is Sonoma’s second dental product in the U.S., and was developed with its partner Gabriel Science, LLC. Additionally, in Switzerland, Sonoma and its partner, Medical Systems Solutions, have launched Microdacyn® Oral Care for both professional and consumer use.

After successfully launching Endocyn® for root canal irrigation in December 2020, Sonoma’s second dental product in the U.S. is an oral hygiene rinse. OroGenix Oral Hygiene Rinse uses Sonoma’s patented Microcyn® technology to cleanse teeth, gums, and mouth.

https://finance.yahoo.com/news/sonoma-pharmaceuticals-announces-expanded-dental-110000829.html

Adamis: National Institutes of Health Highlights,' “Tempol: Potential Home Treatment for COVID-19'

 NIH Researchers Contend that Tempol can be taken orally and may stop the replication of the virus that causes COVID-19

Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) today highlighted that the NIH has identified Tempol as a potential home treatment for COVID-19 (TEMPOL: A Potential Home Treatment for COVID-19 | NIH COVID-19 Research). The NIH news stated that, “This treatment would likely prevent severe disease.” The article went on to describe how Tempol could reduce COVID-19 symptoms by calming inflammation, protecting organs from damage, and decreasing the clumping of platelets. The U.S. Food & Drug Administration (FDA) has given the go-ahead to Adamis Pharmaceuticals to conduct a clinical study using Tempol as an at home treatment to prevent disease progression and thereby releasing the burden of COVID-19 on the healthcare system. Adamis plans to initiate the study shortly.

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, commented: “Tempol’s multiple activities, including antioxidant, anti-inflammatory, and antiviral, suggest that Tempol could be an ideal treatment for COVID-19. It would eliminate the concerns regarding the introduction of new variants. As new variants arise and vaccines become less effective, Tempol’s antiviral and anti-inflammatory effects are independent of the evolving virus. Furthermore, the oral delivery of the drug may be an ideal outpatient treatment, preventing increased healthcare utilization. Tempol’s mode of action makes it an ideal candidate to treat not only COVID-19, but many other types of viral respiratory infections, including influenza and respiratory syncytial virus.”

Adamis has previously licensed exclusive worldwide rights under patents, patent applications and related know-how to use Tempol for the treatment of respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19.

https://finance.yahoo.com/news/adamis-highlights-national-institutes-health-113000966.html