Advisory Committee Meeting to Discuss Janssen Biotech Vaccine

 Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021

  • Discuss data submitted in support of safety and effectiveness for EUA for a COVID-19 vaccine
  • VRBPAC members are independent, scientific and public health experts who advise FDA on the safety and effectiveness data
  • Final EUA decision made by FDA


Medical Product Development to Address New Virus Variants

FDA actively assessing impact of new strains on safety and effectiveness of authorized products

  • Guided by prior experience with evolving infectious diseases e.g. Influenza, HIV
  • Communicating with medical product sponsors on impact of COVID-19 variants on their products
  • New therapeutics: Focus on expediting virus-targeting monoclonal antibodies
  • New diagnostics: Focus on  in silico monitoring to assess for mutations and impact



Eli LIlly

INDICATION: Treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19

The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions

MECHANISM OF ACTION: Monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells; the mAbs to different but overlapping sites on the spike protein of the virus


  • Placebo-controlled clinical trial of patients with COVID-19 at high risk for disease progression
  • Single iv of mAbs significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up vs. compared to placebo
  • Safety and effectiveness continue to be evaluated



Convalescent Plasma EUA updated to Reflect New Data

EUA revised to limit use of high titer COVID-19 convalescent plasma

  • For the treatment of hospitalized patients with COVID-19 early in the disease course
  • For hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response
  • Plasma with low levels of antibodies has not been shown to be helpful in COVID-19
  • Transfusion of COVID-19 convalescent plasma in hospitalized patients late in the course of illness (e.g. following respiratory failure requiring intubation and mechanical ventilation) has not been associated with clinical benefit


Image credit: FDA