Covid-19
F.D.A. Plans to Allow 12- to 15-Year-Olds to Receive Pfizer Boosters:“The Food and Drug Administration is planning to broaden eligibility for coronavirus vaccine booster doses on Monday, allowing 12- to 15-year-olds to receive third doses of Pfizer-BioNTech’s vaccine, according to people familiar with the agency’s deliberations.”
Johnson & Johnson booster slashes risk of Omicron hospitalisation, study shows: “Two doses of the Johnson & Johnson Covid-19 vaccine cut the risk of hospitalisation by up to 85 per cent, according to a South African study conducted when the Omicron coronavirus variant was dominant. The findings of the real-world study, made public on Thursday and not yet peer-reviewed, provide a significant fillip to the J&J shot, widely used in South Africa and elsewhere.”
Omicron-Infected People Also Mount Strong Resistance to Delta, Study Finds: “People vaccinated against COVID-19 who get an Omicron infection appear to have a low risk of Omicron reinfection, as well as significantly increased resistance to the Delta variant, new South African data suggest.
However, immune response varies widely among unvaccinated people, suggesting that they may be susceptible to repeat Omicron infections as well as Delta reinfection, according to Alex Sigal, a virologist at the Africa Health Research Institute, Durban.”
Five tactics used to spread vaccine misinformation in the wellness community, and why they work: A really good explanation of the subject of the headline.
About pharma
HHS appeals judge's ruling that drugmakers can cut off 340B sales to contract pharmacies: “The Biden administration is appealing a federal ruling that said drugmakers have the authority to restrict sales of 340B-discounted products to contract pharmacies.
The Department of Justice filed an appeal Tuesday to a lawsuit brought by Novartis and United Therapeutics over drugmakers’ ability to cut off sales to contract pharmacies. It also appealed several aspects of other rulings in separate lawsuits brought by Eli Lilly, Sanofi and Novo Nordisk.”
And in a related article: AbbVie to restrict 340B discounts to safety net hospitals: “AbbVie said it will stop offering safety net hospitals 340B drug-pricing program discounts on drugs dispensed at contract pharmacies if the hospitals fail to turn over patient claims data for those pharmacies to the drugmaker.
AbbVie will begin the initiative Feb. 1, according to a Dec. 29 letter the drugmaker sent to safety net hospitals.”
New York jury holds drugmaker Teva liable in opioid crisis: “Drugmaker Teva Pharmaceuticals is responsible for contributing to the opioid crisis, a suburban New York jury ruled Thursday in one of few verdicts so far among thousands of lawsuits nationwide over the painkillers.
A separate trial will follow to determine what Teva will have to pay in the case…”
About medical devices
Chicago-based Hillrom faces antitrust lawsuit over hospital bed sales: “In the federal lawsuit filed Tuesday in Chicago, hospital bed-maker Linet alleges Hillrom, the main provider of hospital beds in the U.S., used ‘anti-competitive’ practices to slow Linet’s growth in the U.S. market, including “coercing” hospital administrators into locking entire health systems into long-term agreements.
Hillrom, which the lawsuit calls a ‘serial abuser of antitrust laws,’ makes up at least 70% of standard, intensive care and birthing beds installed in U.S. hospitals, according to the complaint.”
Considering the recent Baxter announcement that it is purchasing Hillrom, the timing of the suit is “interesting.”
FDA Issues Draft Device Guidance in Preparation for the End of the Public Health Emergency: The FDA published “guidance documents describing the regulatory requirements for devices that were authorized under the emergency use authorization (EUA) process (EUA Devices) and those under temporary FDA policies implementing specific enforcement discretion during the pandemic (Enforcement Policy Devices) once the Public Health Emergency for COVID-19 (PHE) ends. These guidance documents, Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Transition Plan Guidances), are critically important for manufacturers that developed and produced new devices or modified legally marketed devices specifically in response to the pandemic to help diagnose, cure, treat, or mitigate the symptoms of COVID-19.”
About health insurance
Increasing Medicaid’s Stagnant Asset Test For People Eligible For Medicare And Medicaid Will Help Vulnerable Seniors: “We estimated that increasing Medicaid’s asset limit by the Consumer Price Index, to Medicare Savings Program levels, or to $10,000 for individuals and $20,000 for couples would increase Medicaid eligibility by 1.7 percent, 4.4 percent, and 7.5 percent, respectively. Simplifying Medicaid’s asset test to focus only on certain high-value assets would increase eligibility by 20.5 percent. Increasing asset limits would lessen restrictions on Medicaid eligibility that arise from stagnant asset tests, broadening eligibility for certain low-income Medicare beneficiaries and allowing them to retain higher, yet still modest, savings.”
About healthcare IT
AP-NORC SURVEY: USE OF TELEHEALTH BY OLDER ADULTS WIDESPREAD DURING THE PANDEMIC, BUT ADDRESSING ACCESS ISSUES AND QUALITY CONCERNS KEY TO SUSTAINING ITS USE: “According to the survey, funded by The SCAN Foundation, 62% of adults age 50 and older have received care through some form of telehealth since the beginning of the pandemic, especially for non-urgent health concerns and prescription consultations. Those who have received care through telehealth were generally comfortable doing so, and nearly two-thirds are at least somewhat likely to seek care through telehealth after the pandemic ends.
The convenience of finding an appointment, meeting with a specific provider, and getting an immediate response are the top reasons why adults age 50 and older choose telehealth over in-person care. On the other hand, about two-thirds express concerns about the quality of care received through telehealth.”
Association of Physician Characteristics With Early Adoption of Virtual Health Care: “In a cross-sectional study of 3473 physicians in a large regional health care system, more than 94% transitioned to include virtual health care in their practice by December 2020. Female, behavioral health, and primary care physicians were more likely to be early adopters, and physicians born between 1928 and 1945 (Silent Generation) and in surgical specialties were less likely to be early adopters.”