The EMA has started a rolling review of AstraZeneca’s COVID-19 vaccine with early non-clinical data, while the FDA still has a hold in place for the U.S. Phase III trial.
The EMA has also started a rolling review of BioNTech’s and Pfizer’s COVID-19 vaccine with early non-clinical data, a few days after initiating the rolling review for AstraZeneca’s vaccine.
The National Academies of Sciences, Engineering, and Medicine have made recommendations to NIH regarding the distribution of a COVID-19 vaccine (s), when one or more are available.
VIR and GSK announced the initiation of the 1,300 patient, Phase III portion of the COMET-ICE trial to evaluate whether VIR-7831 prevents mild or moderate COVID-19 patients from worsening as indicated by an increase in hospitalizations or death.
CPI-006 is a monoclonal antibody for CD73 that activates lymphocytes, induces the production of antigen-specific immunoglobulin from B cells and increases production of CD4+ and CD8+ cells. CPI-006 is being developed by Corvus Pharmaceuticals as a cancer treatment.
The 11,000 patient RECOVERY trial has several arms testing lopinavir-ritonavir, dexamethasone, hydroxychloroquine, azithromycin, tocilizumab, REGN-COV2 and convalescent plasma. In the lopinavir-ritonavir arm of the RECOVERY trial (NCT04381936), 1,616 patients that received lopinavir-ritonavir were compared to 3,424 patients that received only usual care. Lopinavir-ritonavir did not improve mortality at 28-days compared to usual care (23% vs 22%), nor did the drugs decrease the duration of hospital stay, or the risk of progressing to invasive mechanical ventilation.