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.