About Covid-19
Biden-Harris Administration secures 3.2 million doses of Novavax COVID-19 Vaccine “The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD)…announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC)…
The Novavax COVID-19 Vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines. The Novavax vaccine contains a very small amount of the SARS-CoV-2 spike protein, which elicits an immune response, in combination with an adjuvant, which boosts the immune system response to vaccine.”
Boston researchers may have found biomarker for long COVID
“Researchers have found the SARS-CoV-2 spike protein circulating in the blood of long COVID-19 patients up to 12 months after they were diagnosed, The Boston Globe reported.
The scientists said the findings suggested the spike protein was a potential biomarker that could be helpful in diagnosing and treating long COVID patients.
‘Strikingly, we detect SARS-CoV-2 spike antigen in a majority of [long COVID] patients up to 12 months post-diagnosis, suggesting the presence of an active persistent SARSCoV-2 viral reservoir,’ the study said.
Meanwhile, the spike antigen was not detected in patients who recovered from COVID-19 but did not get long COVID.
Senior author David Walt said the results suggest that ‘if someone could somehow get to that viral load and eliminate it, it might lead to resolution of symptoms.’”
About hospitals and healthcare systems
Trends in Adverse Event Rates in Hospitalized Patients, 2010-2019 “In this serial cross-sectional study of 244 542 adult patients hospitalized in 3156 US hospitals from 2010 to 2019, there were statistically significant decreases in the annual rates of in-hospital adverse events for admissions for acute myocardial infarction (annual adjusted relative risk [RR], 0.94), heart failure (RR, 0.95), pneumonia (RR, 0.94), major surgical procedures (RR, 0.93), and all other conditions (RR, 0.97).”
Despite these improvements, as the accompanying editorial (Improvements in Hospital Adverse Event Rates) notes: “the report by Eldridge and colleagues on a decade of hospital trends is an unfortunate reminder that adverse events remain unacceptably frequent.”
About pharma
FDA rule would facilitate prescription-to-OTC switches but nix a third class of drugs “After a decade-long wait, the Food and Drug Administration finally issued a proposed rule in late June that would make it easier for pharmaceutical companies to switch products from prescription-only to over-the-counter status while still retaining a prescription version.
Under the rule, patients would enjoy access to medications that previously required an office visit and a prescription, while payers would reap the financial benefits of fewer medical and prescription claims. Whether the change would be a challenge or an opportunity for pharmacies depends entirely on how the rule is implemented. [Comment: And relative charges.]
Under the proposed rule, an OTC drug could have the same active ingredient, dosage form, strength, route of administration, and indication as its prescription-only counterpart.
What the rule does not do is create a third class of drugs that would not require a prescription yet, instead of being available over the counter, would be ‘behind-the-counter’ and could be purchased only after consulting with a pharmacist. The possibility of this third class has been in play since 2012.”
Effect of Pharmacogenomic Testing for Drug-Gene Interactions on Medication Selection and Remission of Symptoms in Major Depressive Disorder [MMD] “In this randomized clinical trial that included 1944 patients with MDD, provision of pharmacogenomic tests for drug interactions compared with usual care resulted in prescriptions with no predicted drug-gene interactions in 45% vs 18%, respectively, a difference that was statistically significant. Remission of symptoms reached a maximum difference of 16.5% vs 11.2% at 12 weeks but was not significantly different at 24 weeks.”
Is genome sequencing valuable for preventing drug-drug interactions or improving targeted treatments? The answer varies with different drugs and illnesses.
See the accompanying editorial: Pharmacogenomic Testing for Next-Step Antidepressant Selection
About the public’s health
Spirituality in Serious Illness and Health “Question How can considerations of spirituality guide health care and health outcomes?…
The serious illness Delphi expert panel review identified 8 findings, as enumerated: (1) spirituality is important to most patients with serious illness (eg, literature estimates ranged from 71%-99%); (2) spiritual needs are common in that setting (eg, estimates ranged from 23%-98%); (3) spiritual care is frequently desired by patients with serious illness (eg, estimates ranged from 50%-96%); and (4) spirituality can influence medical decision-making in serious illness. Despite these findings, (5) spiritual needs of patients with serious illness are frequently unaddressed within medical care, especially since (6) spiritual care is infrequent in the care of such patients (eg, estimates of patients not receiving spiritual care ranged from 49%-91%). Findings noted that (7) the provision of spiritual care in the medical care of patients with serious illness was associated with better end-of-life outcomes, while (8) unaddressed spiritual needs can be associated with poorer patient quality of life.”
Look at the definitions and Tables 4 and 5.
Apgar scores are less predictive of infant mortality for Black babies than white ones, study finds ”The study, published Tuesday in PLOS Medicine, found that more Black infants were assigned low Apgar scores than white infants and that the scores were better at predicting death in the first year of life in white infants compared with Black babies.”