COVID-19 Update #68 for 2/10/2021

COVID-19 Vaccines
 
J&J requested an emergency use authorization (EUA) for its COVID-19 on 2/4/2021, based on the results of the Phase III ENSEMBLE trial. The FDA scheduled a meeting of the Vaccines and Related Biological Products Advisory Committee on 2/26/2021 to review the vaccine.
 
British researchers are going to test the use of different COVID-19 vaccines for the first and second doses. One trial will give the Pfizer-BioNTech vaccine first and follow it with the AstraZeneca vaccine, while another cohort will receive the vaccines in reverse order. An AstraZeneca trial will evaluate the AZ vaccine with the Russian Sputnik V vaccine.
 
A preprint study described the results of an analysis of circulating SARS-CoV-2 viruses, described how the incidence of the B.1.1.7 (U.K.) variant) is growing and expected to become the dominant strain by March 2021.
 
A preprint draft of a subset of 499 patient from a Phase III trial (NCT04400838, ISRCTN15281137.5), found the efficacy of the AstraZeneca COVID-19 vaccine was 75% against B.1.1.7 (U.K. variant) and 84% against original SARS-CoV-2 viruses in preventing symptomatic infection. The vaccine was less efficacious for asymptomatic infection, 27% for B.1.1.7 compared to 75% for original viruses.
 
In an analysis of a 2,000 patient trial, South African researchers found the AstraZeneca COVID-19 vaccine provided a minimal decrease in mild-to-moderate COVID-19 caused by the B.1.351 mutation. South Africa is pausing use of the AZ vaccine, while results are being examined. Researchers plan to examine whether the AZ vaccine will prevent severe COVID-19 caused by the South African mutation (B.1.351).
 
Pakistan’s health minister announced that interim results from the Pakistani cohort enrolled in a 30,000 patient, Phase III trial (NCT04526990) found that CanSino’s COVID-19 vaccine demonstrated 65.7% efficacy in preventing symptomatic cases and a 90.98% success rate in stopping severe disease. Interim results were reported after 101 cases of COVID-19 developed in the trial cohort.
 
COVID-19 Antivirals
 
Merck announced that after reviewing available data, the company has concluded there is a lack of pre-clinical, clinical and safety data to support the use of ivermectin as a treatment for COVID-19.
 
COVID-19 Antibodies
 
The FDA granted an emergency use authorization (EUA) to Lilly’s monoclonal antibody mixture of bamlanivimab and etesevimab, on 2/9/2021, to treat mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19
 
The FDA issued an emergency use authorization (EUA) for convalescent plasma, on 8/23/2020, for the treatment of hospitalized patients with COVID-19. The original EUA was granted for any convalescent plasma product collected at FDA registered blood establishments. In February 2021, the FDA narrowed the EUA to high-antibody-titer convalescent plasma. Eligible patients include hospitalized patients with COVID-19 early in the disease course or impaired humoral immunity. The FDA no longer authorizes the use of plasma with low SARS-CoV-2 antibody titers. Fact sheets have been created for health care providers and patients. The Fact Sheet for HCPs has been revised to reflect the changes in the EUA. The documents include dosing instructions and potential adverse effects, such as allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.
 
COVID-19 Anti-inflammatories
 
Bisindole (VERU-111) binds to and crosslinks the alpha and beta tubulin subunits of microtubules and intermediate filaments of cells resulting in disruption of the cytoskeleton. Veru is developing bisindole for the treatment of castration resistant prostate cancer and triple negative breast cancer. Veru is evaluating bisindole as a treatment for COVID-19 because of antiviral and anti-inflammatory effects.

• Due to its direct effects on S protein-microtubule trafficking, bisindole may decrease viron production and virus replication. Bisindole is also an anti-inflammatory agent and may reduce virally induced severe inflammation and cytokine storm. 
• Veru announced that in a 38 patient, Phase II trial (NCT04388826), a 21-day treatment with bisindole resulted in 94.4% of patients being alive without respiratory failure at Day 29 compared to 70% with placebo in hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS).