Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.Continue reading

Are COVID-19 Vaccines Safe and Effective?

COVID-19 Vaccines are viewed as the light at the end of the tunnel.  We are not there yet but we will get there.  Hundreds of millions of people in the United States and billions of people globally will need to be immunized against COVID-19.  But, are these vaccines safe and effective?  Would you recommend that someone you love get one?

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Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released

An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months.Continue reading

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

  • Vaccine Candidate 72% Effective in the US and 66% Effective Overall at Preventing Moderate to Severe COVID-19, 28 Days after Vaccination
  • 85% Effective Overall in Preventing Severe Disease and Demonstrated Complete Protection Against COVID-19 related Hospitalization and Death as of Day 28
  • Protection Against Severe Disease Across Geographies, Ages, and Multiple Virus Variants, including the SARS-CoV-2 Variant from the B.1.351 Lineage [1] Observed in South Africa
  • Single-shot compatible with standard vaccine distribution channels provides important tool in pandemic setting

[1] The B.1.351 lineage also known as 501Y.V2 variant and 20H/501Y.V2 (formerly 20C/501Y.V2) is a variant of SARS-CoV-2, the virus that causes COVID-19Continue reading