HHS and the BARDA awarded Pfizer and BioNTech $1.95 billion for the first 100 million doses of their experimental COVID-19 vaccine as part of operation Warp Speed. The U.S. government also has an option for an additional 500 million doses.
Novavax signed an agreement with Fujufilm Diosynth Biotechnologies to manufacture the Novavax COVID-19 vaccine NVX-CoV2373. Novavax expects to announce the results of its Phase I trial in early August and begin the Phase II trial in mid-August. A 30,000 patient Phase III trial is expected to begin in the fall.
Glenmark Pharmaceuticals announced that in a 150 patient, open-label, Indian Phase III trial, treatment with favipiravir added to supportive care resulted in 28.6% faster viral clearance and a 40% faster attainment of clinical cure compared to supportive care alone in patients with mild to moderate COVID-19. Patients were initiated on favipiravir within 48-hours of a positive test. Glenmark did not specify whether other antivirals were included in standard supportive care in India.
In a 15-day, 423 patient, Phase III, Brazilian trial, hydroxychloroquine alone or with azithromycin did not improve clinical status (7-point scale from hospitalized and no symptoms to death) compared to placebo in hospitalized patients with COVID-19. Hydroxychloroquine alone or with azithromycin was associated with a prolongation of the QT interval and an increase in liver-enzymes.
Researchers at Montefiore Medical Center retrospectively reviewed the medical records of 1,806 hospitalized COVID-19 patients and found that glucocorticoids administered within 48 hours of admission was not associated with a decrease in mortality or mechanical ventilation. However, patients with a CRP of 20 mg/dL or greater had a reduced risk of mortality and mechanical ventilation, while use in patients with a CRP < 10 mg/dL was associated with an increased risk of mortality or mechanical ventilation.