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What We're Reading: COVID-19 Vaccine Mandates; Guidance for Prostate Cancer Trials; Ongoing COVID-19 Variant Threat
Anthony Fauci, MD, addresses potential vaccine mandates once COVID-19 vaccines gain full approval; the FDA issues finalized guidance on using a metastasis-free survival end point in clinical trials of patients with prostate cancer; spotlighting the threat of variant spread and mutation amid case surges nationwide.
Fauci on Vaccine Mandates After Full Approval of COVID-19 Vaccines
As reported by USA Today, the nation’s top infectious disease expert and chief medical advisor to President Joe Biden, Anthony Fauci, MD, said this past Friday there will be “a flood” of vaccine mandates at businesses and schools nationwide once the FDA issues a full approval for a COVID-19 vaccine. Although mandates will likely not occur at a federal level, Fauci said that the approval would encourage organizations, universities, and hospitals to require proof of vaccination for workers and students. Currently, each FDA-approved COVID-19 vaccine is under emergency use authorization status, which Fauci hopes will be expanded to full approval in the next few weeks.
FDA Issues Guidance on Use of Metastasis-Free Survival End Point
The FDA has issued finalized guidance on the use of metastasis-free survival (MFS) as an end point in clinical trials for patients with nonmetastatic castration-resistant prostate cancer. Reported by Regulatory Focus, the final guidance provides recommendations for sponsors on general trial design, imaging, and interpretation of trial results and analyses of MFS, which could prove useful in determining the efficacy of potential drugs earlier in the disease course. Coming 3 years after the FDA initially released a draft version on the guidance for MFS, some therapies have already been approved on the basis of MFS as a primary end point.
Threat of Variant Spread Continues Amid Surge in Cases
With surges in COVID-19 infections and hospitalizations in states such as Texas and Florida mirroring or even surpassing rates seen at the onset of pandemic, an article by CNN Health highlights the threat of variant spread and mutation among unvaccinated individuals across the nation. According to Johns Hopkins University, the United States is averaging its highest rate of daily COVID-19 cases in nearly 6 months, with a 10% increase in 7-day case averages observed among 47 states in the past week. Vaccines have been shown to provide effective protection against severe disease for those infected with the more transmissible delta variant, but concerns have been noted on whether vaccinated individuals can still spread the virus.
New Research Challenges Assumptions About Hospital-Physician Integration, Medicare Patient Mix
April 22nd 2025On this episode of Managed Care Cast, Brady Post, PhD, lead author of a study published in the April 2025 issue of The American Journal of Managed Care®, challenges the claim that hospital-employed physicians serve a more complex patient mix.
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Symptom Documentation Differences in Acute Cancer Care Suggest Sociodemographic Disparities
April 22nd 2025Researchers are calling for more targeted efforts to improve health equity after a new analysis revealed that cancer symptom documentation and burden vary across certain demographics.
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Personalized Care Key as Tirzepatide Use Expands Rapidly
April 15th 2025Using commercial insurance claims data and the US launch of tirzepatide as their dividing point, John Ostrominski, MD, Harvard Medical School, and his team studied trends in the use of both glucose-lowering and weight-lowering medications, comparing outcomes between adults with and without type 2 diabetes.
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