COVID-19 Update #98 for 9/10/2021

COVID-19 Vaccines
 
An analysis of antibody levels in 1,647 Belgium health care workers found higher antibody titers after two doses of the Moderna COVID-19 vaccine compared to the Pfizer-BioNTech vaccine, whether or not the patient had previously been infected with COVID-19. The increase in antibody titers was higher after infection than the difference between the two vaccines. It is unknown if the difference in antibody levels is clinically significant.
 
COVID-19 Antivirals
 
Merck initiated a trial to evaluate molnupiravir in the prevention of COVID-19 in the 14-day, 1,332 Phase III, MOVe-AHEAD trial (NCT04939428), in adults who live with a symptomatic patient with a confirmed coronavirus infection.
 
Pfizer is evaluating PF-07321332 in combination with ritonavir in the treatment of COVID-19. PF-07321332 is a protease inhibitor. It is administered with ritonavir to slow the metabolism of PF-07321332, to increase its half-life. 

• Pfizer initiated a trial to evaluate PF- 07321332 in combination with ritonavir in the treatment of COVID-19 in a 28-day, 1,140 Phase III trial(NCT05011513), in symptomatic patients who have not been hospitalized and aren’t at high risk of severe illness

 
COVID-19 Anti-Infammatories
 
In the 1,525 patient, Phase III, COV-BARRIER trial (NCT04421027), adding baricitinib to standard of care did not decrease the proportion of patients who progressed to high-flow oxygen, non-invasive ventilation, invasive mechanical ventilation, or death by day 28. However, treatment with baricitinib did decrease mortality at 28-days (8% vs 13%) and 60-days (10% vs 15%).
 
The FDA has requested an additional study to evaluate treatment with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 in order to be considered for an EUA.
 
The FDA declined Humanigen’s request for an emergency use authorization for lenzilumab to treat newly hospitalized COVID-19 patients due to inadequate safety and efficacy data.
 
COVID-19 Antibodies
 
The FDA reapproved the use of Lilly’s COVID-19 monoclonal antibody combination of bamlanivimab and etesevimab to be used in all U.S. states, territories, and jurisdictions. This expands the use authorized on 8/27/2021 from 20 states to all states. The Assistant Secretary for Preparedness and Response will resume distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use).
 
If there are logistical constraints to administering COVID-19 monoclonal antibodies, NIH recommends

• Prioritizing the treatment of COVID-19 over prophylaxis of COVID-19
• Giving priority to unvaccinated or incompletely vaccinated individuals at high risk of progressing to severe disease and vaccinated individuals who are not expected to mount an adequate immune response.