About Covid-19
CDC backs Moderna COVID-19 shots after full US approval: “The Centers for Disease Control and Prevention on Friday continued its endorsement of Moderna’s COVID-19 vaccine for adults, now that U.S. regulators have given the shots their full approval.
The decision has little practical effect. Tens of millions of Americans have already gotten Moderna shots, following its emergency authorization by the Food and Drug Administration more than a year ago.
Earlier…, the FDA gave the product full licensure, following the kind of rigorous, time-consuming review given to other vaccines.”
Walgreens, CVS lift rapid test purchase limits: Increased stocking of tests has eliminated limits in most locations.
U.S. considers lengthening gap between first 2 COVID shots to 8 weeks: “U.S. health officials on Friday said they are considering lengthening the recommended interval between the first two doses of the most widely used COVID-19 vaccines to eight weeks to lower the risk of heart inflammation and improve their effectiveness.”
High Rates of Rapid Antigen Test Positivity After 5 days of Isolation for COVID-19: PREPRINT, NOT YET PEER REVIEWED.
”These results indicate that a substantial proportion [~40%] of individuals with COVID-19 are likely still contagious after day 5 of illness regardless of symptom status. Early liberation from isolation should be undertaken only with the understanding that inclusion of individuals on day 6-10 of illness in community or work settings may increase the risk of COVID-19 spread to others which, in turn, may undermine the intended benefits to staffing by resulting in more sick workers.”
16 states renew fight against CMS' vaccine rule: No, this article is not a few months old. It is from today.
”Sixteen state attorneys general asked a federal judge Feb. 4 to block the federal vaccine mandate for healthcare workers…
Fourteen of the attorneys general are from the 24 states that were affected by the Jan. 13 Supreme Court decision that upheld CMS' vaccination mandate for eligible staff at healthcare facilities participating in the Medicare and Medicaid programs.”
As before, the issue claimed by the plaintiffs is that the requirements reduce the availability of already critical staff shortages. These shortages have become worse with omicron-variant infections.
About health insurance
Association of Health Insurance Literacy With Enrollment in Traditional Medicare, Medicare Advantage, and Plan Characteristics Within Medicare Advantage: “In this cross-sectional study of 6627 Medicare beneficiaries, higher health insurance literacy—particularly, annual review and comparison of coverage choices—was associated with higher Medicare Advantage enrollment and choice of low-cost or high-rated Medicare Advantage plans. However, health insurance literacy was low among Medicare beneficiaries with low socioeconomic status.
Meaning These findings suggest that policy makers should develop programs to make health insurance information accessible and understandable and to encourage annual review and comparison of coverage options, especially for vulnerable populations.”
Medical Crowdfunding and Disparities in Health Care Access in the United States, 2016‒2020: “Campaigns raised more than $2 billion from 21.7 million donations between 2016 and 2020. Returns were highly unequal, and success was low, especially in 2020: only 12% of campaigns met their goals, and 16% received no donations at all. Campaigns in 2020 raised substantially less money in areas with more medical debt, higher uninsurance rates, and lower incomes.
Conclusions. Despite its popularity and portrayals as an ad-hoc safety net, medical crowdfunding is misaligned with key indicators of health financing needs in the United States. It is best positioned to help in populations that need it the least.”
About pharma
Top 10 most anticipated drug launches of 2022: FYI
FDA announces proposed rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers: “FDA is announcing the availability of the proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers…as required by the Drug Supply Chain Security Act (DSCSA). The proposed rule, when finalized, would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain.
Requirements for wholesale drug distributors currently vary significantly across state lines creating a patchwork system. In passing DSCSA, Congress believed a uniform national standard would address this issue.”
The hits keep coming: Biogen's Aduhelm marketing, approval under fire in new FTC and SEC probes: “The Federal Trade Commission (FTC) and the Securities and Exchange Commission (SEC) have launched two separate investigations into Biogen and its troubled Alzheimer’s med, the company revealed in an annual securities filing Thursday.
The FTC has made a civil investigative demand—a type of administrative subpoena—in pursuit of documents related to Aduhelm’s marketing and approval, plus healthcare sites, the company said.
The SEC, meanwhile, has launched a separate inquiry that also seeks marketing and approval information on the beleaguered anti-amyloid antibody.”
In a victory for medical journals, Pacira loses a libel lawsuit over ‘faulty scientific research’ allegations: “A federal judge has dismissed an unusual libel lawsuit brought by Pacira BioSciences that claimed a medical journal, its editor, and the authors of several papers published articles that were based on “faulty scientific research” that portrayed its only medicine as ineffective.
Pacira alleged the papers, which were published early last year in the journal Anesthesiology, reflected a ‘bias’ against its Exparel painkiller and ‘disparaged’ the drug, as we noted at the time.”
Sanofi drops Pasteur, Genzyme names as it simplifies brand: “Sanofi on Thursday unveiled a new corporate brand and said that it will no longer use the Genzyme and Pasteur names as it moves forward with one shared identity. The overhaul follows a similar move made in 2011, when the company dropped Aventis from its name in an effort to simplify its brand.”
About the public’s health
Weekly U.S. Influenza Surveillance Report: Some key points”
“The majority of influenza viruses detected are A(H3N2). Most of the H3N2 viruses identified so far this season are genetically closely related to the vaccine virus. Some viruses show antigenic differences that developed as H3N2 viruses have continued to evolve.
The percentage of outpatient visits due to respiratory illness decreased nationally again this week and is now below baseline. Influenza is contributing to levels of respiratory illness, but other respiratory viruses are also circulating. The relative contribution of influenza varies by location.
The number of hospital admissions reported to HHS Protect declined slightly again this week.
The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate for the entire 2020-2021 season, but lower than the rate seen at this time during the four seasons preceding the COVID-19 pandemic.”
Global urban temporal trends in fine particulate matter (PM2·5) and attributable health burdens: estimates from global datasets: “Although regional averages of urban PM2·5 concentrations decreased between the years 2000 and 2019, we found considerable heterogeneity in trends of PM2·5 concentrations between urban areas. Approximately 86% (2·5 billion inhabitants) of urban inhabitants lived in urban areas that exceeded WHO's 2005 guideline annual average PM2·5 (10 μg/m3), resulting in an excess of 1·8 million (95% CI 1·34 million–2·3 million) deaths in 2019. [Emphasis addded]Regional averages of PM2·5-attributable deaths increased in all regions except for Europe and the Americas, driven by changes in population numbers, age structures, and disease rates. In some cities, PM2·5-attributable mortality increased despite decreases in PM2·5 concentrations, resulting from shifting age distributions and rates of non-communicable disease.”
Workers of color and LGBTQ employees face healthcare inequity regardless of income: “Management consulting firm McKinsey and Company’s report on healthcare inequity in the workplace found that 69% of employees of color and 66% of LGBTQ employees who earn up to $100,000 a year experienced two or more unmet basic needs, such as personal safety, social support and food security. Meanwhile, only 49% of white employees felt similarly. Workers with one or more unmet basic needs were around 2.4 times more likely to have not received needed physical healthcare while focusing on immediate concerns like housing and safety.”
New highly virulent and damaging HIV variant discovered in the Netherlands: “Individuals infected with the new “VB variant” (for virulent subtype B) showed significant differences before antiretroviral treatment compared with individuals infected with other HIV variants:
• Individuals with the VB variant had a viral load (the level of the virus in the blood) between 3.5 and 5.5 times higher.
• In addition, the rate of CD4 cell decline (the hallmark of immune system damage by HIV) occurred twice as fast in individuals with the VB variant, placing them at risk of developing AIDS much more rapidly.
• Individuals with the VB variant also showed an increased risk of transmitting the virus to others.
Reassuringly, after starting treatment, individuals with the VB variant had similar immune system recovery and survival to individuals with other HIV variants. However, the researchers stress that because the VB variant causes a more rapid decline in immune system strength, this makes it critical that individuals are diagnosed early and start treatment as soon as possible.”
About healthcare IT
Investment firm will take SOC Telemed private in deal valued at $300M: “Healthcare investment firm Patient Square Capital plans to take SOC Telemed private in a deal that values the company at roughly $304.2 million…
Founded in 2004, SOC provides acute telemedicine services to nearly 1,000 facilities, including more than 700 hospitals across 47 states and services 19 of the 25 largest health systems.”
About health technology
Scientists Reveal "Rosetta Stone" of Immune Cell Function: CRISPR genome editing has served as a powerful tool for deleting or altering DNA sequences and studying the resulting effect. A recent variation, known as CRISPRa, allows researchers to forcibly activate genes—rather than edit them—in human cells. Now, researchers at Gladstone Institutes and UC San Francisco (UCSF) have adapted the CRISPRa system to human immune cells…
The scientists activated each gene in the genome in different cells, enabling them to test almost 20,000 genes in parallel. This allowed them to quickly learn the rules about which genes provide the most powerful levers to reprogram cell functions in ways that could eventually lead to more powerful immunotherapies.”
Abbott delivers first implant of its dual-chamber leadless pacemaker in a clinical study: “Abbott has taken a major step in the development of its dual-chamber leadless pacemaker technology, with the company’s first patient receiving two miniaturized, implanted devices within different areas of the heart that synchronize themselves wirelessly to help control the muscle beat by beat.
Traditional pacemaker systems have included a separate power generator placed under the skin near the collarbone, which then connects to the heart with a series of wires. But a new generation of leadless pacemakers, at about one-tenth the size, can be planted inside the heart itself and anchored directly to the muscle wall in a less invasive procedure.”
Zimmer Biomet plots $1B revenue for spine, dental spinoff ZimVie, sets launch date: “When the separation is complete, the standalone public company—dubbed ZimVie after its progenitor and the French word for “life”—will begin trading on the Nasdaq as ‘ZIMV.’ Zimmer Biomet will retain a stake of just under 20% of ZimVie’s outstanding shares of common stock, though the elder company said it would ultimately divest those shares in an unspecified ‘tax-efficient manner.’
The remaining 80% of ZimVie’s outstanding stock will go to current Zimmer shareholders, distributed as one ZimVie share for every 10 Zimmer shares they own.”