Coronavirus Update for May 6, 2020

Coronavirus Update for May 4

Your Coronavirus update for May 6. Stay up to date with Elite.

More than 3.5 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including more than 250,000 deaths. Healthcare officials in the United States have reported more than 1.1 million positive COVID-19 patients and more than 67,000 deaths.

Death Projections Rise Dramatically With U.S. States Begin To Reopen

A new report by the New York Times claims that “quiet” projections by the U.S. Centers for Disease Control & Prevention (CDC) estimate that some 200,000 new daily cases of the novel coronavirus could occur in the United States by the end of May, with 3,000 daily deaths in the U.S. to be expected with news of nearly half of the countries states potentially easing restrictions. By comparison, approximately 25,000 new cases and 1,750 deaths are reported daily in the U.S.

The modeling is reportedly from the CDC and incorporated into a chart prepared by the Federal Emergency Management Agency that circulated within the administration.1

Georgia was the first state to lift some of its coronavirus restrictions when various businesses were permitted to reopen April 24. Shelter-in-place restrictions for residents expired May 4th. Nearly 2,000 cases were reported between May 1 and May 2. According to data compiled by Stanford University’s COVID-19 Case Mapper,2 the risk of exposure to the virus for Georgia citizens has risen by 42 percent. In Texas, where stay-at-home orders have also been lifted, May 3 marked the fourth consecutive day that the state reported more than 1,000 new cases. 

Significant Financial Deficit Impacting Healthcare Industry 

Clinical safety measures throughout the healthcare industry in response to the coronavirus pandemic have culminated in what’s being reported as a dire financial situation, according to a report by the Washington Post.3 From elective surgeries being postponed to a halting of physician’s office visits, the general reduction in patients within medical facilities has caused more than 200 hospitals nationwide to furlough employees and healthcare spending to be reduced at an annualized rate of 18 percent in the first three months of 2020, reportedly the largest reduction since government recordkeeping began in 1959. Likewise, the annualized 4.8 percent decline in the first-quarter gross domestic product has contributed to this figure’s worst overall contraction since the Great Recession. Worse declines are projected for the current quarter, which ends in June, according to the report.

Potential COVID Treatment Gets Emergency Use By FDA

Remdesivir, an investigational antiviral drug, has received emergency use authorization for the treatment of suspected or laboratory-confirmed coronavirus (COVID-19) in adults and children hospitalized with a severe disease by the U.S. Food & Drug Administration (FDA). According to FDA officials, who announced the authorization for Gilead Sciences Inc., Foster City, CA, on May 1, there is limited information known about the safety and effectiveness of using the drug to treat people in the hospital with the virus, but the investigational drug has been shown in a clinical trial to shorten the time to recovery in some patients.

“FDA’s emergency authorization of Remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19,” said Alex Azar, secretary of the U.S. Department of Health & Human Services. 

The authorization allows for Remdesivir to be distributed in the United States and administered intravenously by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease, FDA officials said. Severe disease is defined as “patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support, such as a mechanical ventilator.”

In a prepared statement, Stephen M. Hahn, MD, the FDA’s commissioner, said the authorization is an important step to provide sick patients timely access to new therapies where appropriate while supporting research to further evaluate whether treatments are safe and effective. “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts,” Hahn said.

Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that Remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use, according to FDA officials.

Possible side effects of Remdesivir reportedly include increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.

FDA officials also said they may issue an emergency use authorization to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear threats when there are no adequate, approved, and available alternatives.

The FDA previously allowed for study of the investigational drug under clinical trials, as well as expanded access use for individual patients and through a multi-patient expanded access program coordinated by Gilead, officials said.

The authorization is said to be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the authorization no longer meets the statutory criteria for issuance.

Thank you for joining us at Elite for your Coronavirus Update for May 4, 2020. If you missed last week’s article, please consider reading it here.

References

  1. Coronavirus live updates: models project sharp rise in deaths as states reopen. New York Times. 2020. Accessed online: www.nytimes.com/2020/05/04/us/coronavirus-live-updates.html
  2. COVID-19 research continuity resources. Stanford University. 2020. Accessed online: https://doresearch.stanford.edu/research-scholarship/covid-19-research-continuity-resources
  3.  Romm T, Frankel T. Historic financial decline hits doctors, dentists and hospitals — despite COVID-19 — threatening the overall economy. Washington Post. 2020. Accessed online: www.washingtonpost.com/business/2020/05/04/financial-distress-among-doctors-hospitals-despite-covid-19-weighs-heavily-economy

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