1. MOLNUPIRAVIR EUA REQUEST Merck and Ridgeback Biotherapeutics on October 11 submitted an application with the US FDA for Emergency Use Authorization (EUA) of molnupiravir, an investigation oral antiviral medication, for the treatment of mild-to-moderate COVID-19 in adults at high risk of severe disease. Notably, if authorized by the FDA, the drug would be the first COVID-19 treatment to be administered orally, as all other authorized or approved medications are delivered intravenously or via injection. The companies’ submission is based on a Phase 3 clinical trial interim analysis showing molnupiravir reduced the risk of hospitalization or death by about half when compared with people who received a placebo. The data are not yet published or peer-reviewed. An effective therapeutic that is taken by people recovering at home could relieve some pressure on hospitals, particularly in areas with low vaccination rates. 

Two Indian generic drug manufacturers last week requested permission to end late-stage clinical trials of generic versions of molnupiravir, after the drug did not show “significant efficacy” among people with moderate COVID-19 disease. A Merck spokesperson noted that the Indian studies defined moderate disease differently than the FDA and included patients with more severe disease. The Indian companies are continuing to research the treatment among people with mild COVID-19.

2. ITALY’S GREEN PASS From October 15 through the end of 2021, Italian workers will be required to present a digital or printed “Green Pass” certificate upon entering their workplace, demonstrating that they have recovered from COVID-19 in the last six months, received a negative COVID-19 rapid antigen test result in the last 48 hours, received a negative COVID-19 molecular test result in the last 72 hours, or have been at least partially vaccinated. Workers who do not comply with the new mandate risk fines or suspension. Both civil and violent protests have broken out in response to the September 16 announcement regarding the new mandate in Italy, including reported clashes over the weekend between neo-fascists or other individuals associated with the far right and police. Some employees and policymakers are concerned that a rise in vaccinations may not occur, instead leading to worker shortages due to a lack of available tests. 

The Green Pass already is required in Italy in order to access schools and universities, utilize public transport, participate in gatherings related to civil or religious ceremonies, visit medical facilities or long-term care facilities, access certain public gathering events or spaces, and pass through areas with higher COVID-19 risk—so-called “red” or “orange” zones. The Green Pass also is recognized by the European Union to help travelers avoid COVID-19 travel restrictions. 

Federal vaccine mandates can override Texas’ sweeping new ban, experts say.

”…Courts in the United States have a long history of upholding vaccine mandates,… and of ruling that protecting public health takes precedence over personal choice….The right of the government to impose vaccine mandates has been established at least since 1905, when the Supreme Court ruled that Cambridge, Mass., could require adults there to be vaccinated against smallpox. Later court cases set the legal groundwork for vaccine mandates in schools, health care and other fields…”

(J. Harris:  We Texans don’t like Other Folks telling us what to do, especially not Federal Folks, and mostly, Local Folks don’t like State Folks telling us what to do either. We Texans have had a good long run being our own bosses—EXCEPT where PUBLIC HEALTH is concerned. Even as hardheaded and conservative as I am, I want the Federal Folks to manage and protect the public where certain, mostly communicable diseases, are concerned. States and Counties cannot handle this matter. 

 In addition, Texas’ failure to fully participate in federal Medicaid programs has led to several years of substandard medical care for a significant number of less fortunate and rural Texans and forced the closure or significant modification of many Texas hospitals, emergency rooms, and clinics in rural and small-town Texas. The private, local, personal medical care that most of us grew up with no longer exists, and it is unlikely ever to be resurrected. If you have an accessible physician who knows your name and is competent, you’re fortunate. If you have reasonable access to a “Mission Directed” hospital, you’re fortunate — especially if the hospital has pockets deep enough to survive the occasional pandemic or famine…. But the long-lingering question as to whether good medical care is a right or a privilege is being answered, as it should be.)



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