COVID-19 News: Janssen vaccine review, Impact of new virus variants, Bamlanivimab and Etesevimab for treatment, Convalescent Plasma EUA update
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
BAMLANIVIMAB + ETESEVIMAB
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
SAFETY AND EFFECTIVENESS:
- 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
REGULATORY PATHWAY: EUA
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