The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.

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The first Emergency Use Authorization submission for a COVID-19 vaccine is expected by the third week of November 2020. This follows Pfizer and BioNTech’s announcement that their BNT162b2 vaccine is 90% effective in trial participants.  

This pace is much faster than the typical vaccine development time of 8 years, usually supported by 7 clinical trials and 6 months’ follow-up to catch adverse events. ECRI has called on the Food and Drug Administration (FDA) to insist on no fewer than 6 months of follow-up data from the full trial cohort.

Still, this is welcome news. A record number of COVID-19 hospitalizations has been reported in the United States and nursing home cases have risen fourfold in 20 states. Nursing home staff and frontline workers will likely be the first to receive vaccination. Treatment and risk assessment options (see Topics to Watch) are needed.

 For our early coverage of the BNT162 vaccine, see PCORI COVID-19 Scan, July 9-July 22, 2020.

CD24Fc (SACCOVID) for Treating Severe COVID-19

At a Glance

  • CD24Fc (SACCOVID) is an investigational genetically recombined protein for treating severe COVID-19 that purportedly dampens patients’ overactive coronavirus immune responses.
  • Preliminary data from a phase 3 randomized trial of 203 people hospitalized with COVID-19 suggest that adding CD24Fc to standard care improved the likelihood of clinical recovery by 60% and decreased median time to recovery to 6 days compared with 10 days in the placebo group.
  • The phase 3 randomized, placebo-controlled trial is ongoing, plans to enroll 241 hospitalized patients with severe or critical COVID-19, and has an estimated study completion date of December 2020.

Sepsis Diagnostic Tests to Assess Risk of Severe COVID-19

At a Glance

  • Sepsis is a life-threatening organ dysfunction caused by an overactive immune response to infection. ​
  • Multiple companies are developing sepsis diagnostic​ tests intended to detect early signs of viral-induced sepsis by measuring the levels of genes associated with coronavirus-specific immune responses or changes in the structure of white blood cells as part of a complete blood count.
  • Acute respiratory distress is the earliest and the most common sign of severe coronavirus disease in critically ill patients. Combined with other laboratory and clinical findings, sepsis tests might ​help clinicians identify patients who are more likely to develop severe disease, allowing earlier intervention and improving outcomes.
  • One manufacturer’s sepsis test is cleared by the FDA for use, but its utility in COVID-19 management remains unclear.

Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.

We welcome your comments on this Scan. Send them by email to [email protected].

Posted: November 20, 2020

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