Democrats have three weeks to get their health game on: A really good summary of the health content in the $3.5 trillion spending bill before Congress.
About Covid-19
U.S. administers 364.8 million doses of COVID-19 vaccines - CDC: “The agency said 202,500,853 people had received at least one dose while 171,773,370 people are fully vaccinated as of Wednesday.
The CDC tally includes two-dose vaccines from Moderna and Pfizer/BioNTech, as well as Johnson & Johnson’s one-shot vaccine as of 6:00 a.m. ET on Wednesday.”
”Those figures are up from the 363,915,792 vaccine doses that the CDC said had gone into arms by Aug. 24 out of 428,529,385 doses delivered.”
Moderna completes submission for full FDA approval of Covid-19 vaccine; Pfizer seeks approval for booster dose: “Moderna announced on Wednesday it has completed its submission to the US Food and Drug Administration for full approval of its Covid-19 vaccine for people age 18 and older, and Pfizer and BioNTech announced they have begun submitting data for full FDA approval of a third dose of their vaccine.
Moderna said it has requested priority review from the FDA. The company began submitting data for its Biologics License Application, or BLA, to the FDA in June.”
Japan suspends 1.6 million doses of Moderna shot after contamination reports: “Japan suspended the use of 1.63 million doses of Moderna Inc’s COVID-19 vaccine on Thursday, more than a week after the domestic distributor received reports of contaminants in some vials.
Both Japan and Moderna said no safety or efficacy issues had been identified and the suspension was just a precaution. But the move prompted several Japanese companies to cancel worker vaccinations planned for Thursday.”
Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting: “In this study in a nationwide mass vaccination setting, the BNT162b2 vaccine was not associated with an elevated risk of most of the adverse events examined. The vaccine was associated with an excess risk of myocarditis (1 to 5 events per 100,000 persons). The risk of this potentially serious adverse event and of many other serious adverse events was substantially increased after SARS-CoV-2 infection.”
It is important to note that the risk for myocarditis if infected with the virus is about 5X that of the vaccine.
‘I’m still not planning to get it’: FDA approval not swaying some vaccine holdouts: This quotation sums it up: “‘Most people have multiple reasons and concerns about getting vaccinated — it’s not just one thing,’ said Liz Hamel, a Kaiser Family Foundation director. ‘It may take some time for people to think about it.’”
Holes in reporting of breakthrough Covid cases hamper CDC response: “Forty-nine states are now regularly sending CDC information on hospitalized breakthrough patients. But more than a dozen told POLITICO that they do not have the capacity to match patients’ hospital admission data with their immunization records. Instead, those states rely on hospital administrators to report breakthrough infections. The resulting data is often aggregated, inaccurate and omits critical details for teasing out trends, such as which vaccine a person received and whether they have been fully vaccinated, a dozen state officials said.”
Covid protection for the fully vaccinated is waning, UK study finds: “An analysis from the UK's ZOE Covid app study of over 400,000 people who had received both shots of Pfizer-BioNTech's Comirnaty, showed that it was 88% effective a month after receiving both shots. However, efficacy fell to 74% five or six months after receiving both doses.
In the same study, an analysis of over 700,000 people who had received both doses of AstraZeneca's Vaxzevria showed its effectiveness fell from 77% after a month to 67% at the four- to five-month mark.
he data was collected after May 26, when the Delta variant became the dominant strain…”
COVID booster shots raise protection against severe illness to 97%: “Israeli health ministry figures suggest that after 16 days, a third dose of COVID-19 vaccine [Pfizer] boosts protection against severe illness from the virus to 97%…”
Delta Air Lines to impose $200 monthly surcharge on unvaccinated staff: “Ed Bastian, Delta chief executive, said the airline had decided to impose the $200 monthly surcharge from November to insulate its healthcare plan against the ‘financial risk’ of paying for employees sick with Covid. In a memo to staff seen by the Financial Times, Bastian said the average cost to Delta for an employee’s Covid-related hospitalisation was $40,000 per person and that all of its infected workers in recent weeks had not been fully vaccinated. In addition, a mask mandate will go into effect immediately for unvaccinated Delta workers, and beginning on September 12, employees who are not fully vaccinated must submit to a weekly test.”
FDA greenlights first smartphone-based home COVID-19 test: “Developed by BD in collaboration with the digital testing company Scanwell Health, the Veritor rapid antigen test operates similar to a home pregnancy test, at first. After swishing a nasal swab in a tube of liquid reagents, drops on a testing strip trigger colored lines after about 15 minutes. There the smartphone takes over, using its camera to read and interpret the results more definitively.”
AHA wants OSHA to withdraw COVID-19 standard as ANA seeks to bolster it: “The American Hospital Association (AHA) wants the Biden administration to withdraw a COVID-19 emergency protection standard because it believes hospitals are already doing enough to protect front-line workers.
At the same time, the American Nurses Association (ANA) wants the standard to be even stronger, asking for vaccine mandates to be included in the Occupational Health and Safety Administration (OSHA) temporary standard, which requires employers to provide certain protections such as vital equipment like N95 masks.
The stark difference in views on the standard, which was open for comment until Aug. 20, comes as nurse unions and advocacy groups have charged that hospitals have not done enough to protect workers while facilities say they are following the latest policies and redoubled efforts to shield workers from the virus.”
Texas Governor Issues Order Banning Local Vaccine Mandates: The craziness continues.
”Gov. Greg Abbott issued an executive order on Wednesday banning any state or local mandates requiring people to be vaccinated against COVID-19, and he called on Texas legislators to vote it into law during their current special session.
The move came as Texas reported the most COVID-19 patients in its hospitals since the pandemic began.
Abbott issued his ban in an executive order to fill a loophole left by the full authorization of the Pfizer vaccine. He had previously banned the requirement of vaccinations under emergency use authorizations. He also has banned state and local government mandates for wearing masks.”
About the public’s health
Trends in Nicotine Product Use Among US Adolescents, 1999-2020: “This cross-sectional study, which included 16 years of survey data for between 15 000 and 36 000 students in grades 6 through 12 per year, found that exposure to nicotine products, as assessed by nicotine product days, decreased prior to the popularity of e-cigarettes. This decrease slowed and then reversed owing to the upsurge of vaping; however, adjusting for differential long-term risks of nicotine products, risk-adjusted nicotine product days may have decreased if the risk associated with vaping is sufficiently low compared with that of smoking.”
In 2021, the tobacco industry is projected to spend an estimated $105 million on Formula 1 sponsorship.: “The staggering amount confirms a concerning trend: Tobacco industry spending in F1 has increased, reaching its highest levels since 2006—the year tobacco companies were supposed to be banned from the sport.”
About behavioral health
Mental health giants Headspace and Ginger to merge into $3 billion company: “The new company, called Headspace Health, will have a reported value of $3 billion, placing it in the top echelon of companies vying to own significant chunks of the mental health market.
As investors have thrown huge sums into mental health, there’s been an increasing sense that consolidation must be on the horizon.”
Health Equity, Impact of Pandemic Among Large Employers’ Top Concerns, Says 2022 Health Care Strategy and Plan Design Survey: “Large U.S. employers noted five major areas of concern, including health equity and the pandemic’s long-term impact, as they modify benefits strategies and programs against the backdrop of the ongoing pandemic, according to Business Group on Health’s 2022 Large Employers’ Health Care Strategy and Plan Design Survey.
The survey, released today in Washington, D.C., also showed that top concerns include expanding access to mental health care, monitoring trends in health care delivery and preparing for an uptick in health care spending. The survey’s executive summary is located here.”
About hospitals and health systems
US Nonprofit Hospitals’ Community Health Needs Assessments and Implementation Strategies in the Era of the Patient Protection and Affordable Care Act: “Among the 500 hospitals in our sample, 495 (99.0%) reported on their Internal Revenue Service 990 form that they had conducted a CHNA, and 412 (84.0%) of these CHNAs were identified online. A total of 491 hospitals (99.0%) reported that they adopted an implementation strategy, and 331 of these (75.0%) were identified on their website. In aggregate, 229 (60.0%) of the hospitals in our sample had both a CHNA and corresponding implementation strategy that could be found online.”
Amid rising expenses, Banner Health sees $179M operating income for H1 2021: “Banner Health credited federal pandemic support programs as a major lifeline to its financials during the pandemic.
The system said it has recognized $103 million in Provider Relief Funds during the first half of 2021 and a total of roughly $466 million in stimulus funds overall. In April, it also began recouping the $654 million in Medicare Accelerated and Advance Payments it received, roughly $587 million of which remained by June 30.”
About pharma
AstraZeneca's $39B Alexion buyout bears fruit, yielding late-phase win for potential blockbuster rare disease drug: “The study showed ALXN1840 is better than existing Wilson drugs—trientine, penicillamine, zinc or a combination of the medicines—at mobilizing copper from tissues. Wilson patients suffer from the loss of function in a copper-binding protein, causing the accumulation of the element. As copper accumulates, patients suffer outcomes including liver disease, neurological problems and psychiatric disturbances.”
Gilead wins reversal of $1.2B fine in CAR-T patent fight with Bristol Myer: “Thursday, a federal appeals court overturned a $1.2 billion fine on Gilead subsidiary Kite Pharma that was previously granted to Bristol Myers’ Juno Therapeutics unit and Memorial Sloan Kettering Cancer Center. The legal tussle focuses on whether Gilead’s CD19-targeted CAR-T therapy Yescarta infringed upon a Juno patent that’s licensed from MSK.”
About health insurance
Affordable Care Act’s Shared Savings Program Continues to Improve Quality of Care While Saving Medicare Money During the COVID-19 Pandemic: “The Centers for Medicare & Medicaid Services (CMS) announced today that Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (Shared Savings Program) in 2020 earned performance payments (shared savings) totaling nearly $2.3 billion while saving Medicare approximately $1.9 billion, marking the fourth consecutive year of net savings for Medicare.”
NOTE: While this CMS announcement is dated yesterday, the details are based on January 2020 data.