Several SARS-CoV-2 variants have been identified since the beginning of the COVID-19 pandemic:

  • Alpha (B.1.1.7 and Q lineages)
  • Beta (B.1.351 and descendent lineages)
  • Gamma (P.1 and descendent lineages)
  • Epsilon (B.1.427 and B.1.429)
  • Eta (B.1.525)
  • Iota (B.1.526)
  • Kappa (B.1.617.1)
  • 1.617.3
  • Mu (B.1.621, B.1.621.1)
  • Zeta (P.2)

On November 30, 2021, the U.S. government SARS-CoV-2 Interagency Group (SIG) classified Omicron as Variant of Concern. This classification was based on the following:

  • Detection of cases attributed to Omicron in multiple countries, including among those without travel history.
  • Transmission and replacement of the Delta variant in South Africa.
  • The number and locations of substitutions in the spike protein.
  • Available data for other variants with fewer substitutions in the spike protein that indicate a reduction in neutralization by sera from vaccinated or convalescent individuals.
  • Available data for other variants with fewer substitutions in the spike protein that indicate reduced susceptibility to certain monoclonal antibody treatments.

Possible attributes of a variant of concern are:

  • Evidence of impact on diagnostics, treatments, or vaccines
    • Widespread interference with diagnostic test targets
    • Evidence of substantially decreased susceptibility to one or more class of therapies
    • Evidence of significantly decreased neutralization by antibodies generated during previous infection or vaccination
    • Evidence of reduced vaccine-induced protection from severe disease
  • Evidence of increased transmissibility
  • Evidence of increased disease severity

Every variant of Concern is being closely monitored and characterized by the federal agencies.


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Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

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