FDA Issues EUA for Plasma US Improves from July Levels - Butler Financial, LTD
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FDA Issues EUA for Plasma US Improves from July Levels

Healthcare Policy Analyst Chris Meekins and Biotech Analyst Steve Seedhouse, Ph.D., outline the latest U.S. coronavirus updates.

On August 23, the FDA issued an Emergency Use Authorization (EUA) for convalescent plasma as a treatment for hospitalized coronavirus patients, both intubated and non-intubated.

The basis for the EUA and conclusion that COVID-19 convalescent plasma (CCP) may be effective in the treatment of hospitalized patients includes:

  • A history of convalescent plasma use for respiratory coronaviruses
  • Evidence of preclinical safety and efficacy in animal models
  • Published studies of the safety and efficacy of CCP
  • Data on safety and efficacy from the National Expanded Access Treatment Protocol, sponsored by the Mayo Clinic (over 70,000 treated)

Turning to coronavirus case numbers, U.S. data showed a notable drop-off in number of positive cases this week. However, these numbers may be misleading when you take into account a substantial reduction in the number of daily tests. Average daily cases fell by 17%, from around 51,500 last week to around 42,600 this week; average daily tests dropped by about 9%, from around 739,500 to around 674,300.

On a week-over-week basis, identified cases increased by 5.8% compared to a 7.1% increase the previous week. Remember, though, that this percentage is based on total cases to date, which grows every week. Identified deaths increased by 4.1% compared to 4.3% the prior week. It remains likely that a large number of cases is going unreported.

Looking at the nation as a whole, we continue to believe the U.S. is generally plateauing with some improvements such as reduced hospitalizations, decelerating fatalities and fewer tests returning positive. Heightened mitigation measures (such as wearing masks) in response to July surges have contributed to flattening the curve in August.

Although the U.S. has improved relative to July levels, we believe case spread will continue to ebb and flow for the foreseeable future. It remains to be seen whether an uptick in infections will occur now that some colleges and grade schools are returning to in-person learning. Additional complexity once the flu season picks up in the fall is also possible.

Sources: Raymond James research, The COVID Tracking Project, Food and Drug Administration

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