COVID-19 Update #137 7/14/2022

COVID-19 Vaccines

The FDA issued an EUA for the Novavax COVID-19 Vaccine, on 7/13/2022, to prevent COVID-19 in patients 18 years of age and older. The Novavax COVID-19 Vaccine is administered as a two-dose primary series given three weeks apart. 

Johns Hopkins’ researchers prospectively followed rheumatic and musculoskeletal diseases and solid organ transplant recipients patients who had been vaccinated with either the Pfizer-BioNTech or Moderna COVDI-19 vaccines. While the immune response was similar in patients not receiving immunosuppression the response was higher with the Moderna vaccine in patients receiving immunosuppressive drugs.
 
Moderna announced that an experimental COVID-19 bivalent vaccine containing a combination of the original vaccine and an Omicron BA.1 subvariant specific vaccine, elicited antibody levels for Omicron BA.4 and BA.5 subvariants that were 1.69 times higher than the original vaccine. Moderna is also developing a vaccine targeting the Omicron BA.4 and BA.5 subvariants.
 
COVID-19 Antivirals
 
The FDA rejected a request for an EUA for aviptadil to treat critical COVID-19 with respiratory failure and to treat COVID-19 patients, in November 2021.
 
In June 2022, the FDA rejected a request for an EUA for aviptadil to treat COVID-19 respiratory failure patients who continue to worsen, despite treatment with remdesivir.
 
COVID-19 Anti-Inflammatories
 
Humanigen announced that in the 29-day, 473 patient, NIAID sponsored, Phase II, ACTIV-5/BET-B trial(NCT04583969), adding lenzilumab to remdesivir did not reduce the need for mechanical ventilation compared to remdesivir monotherapy in hospitalized patients with COVID-19.
 
Sabizabulin is an oral microtubule disruptor being developed by Veru as a treatment for metastatic castration-resistant prostate cancer. Because sabizabulin has been shown to have antiviral effects on the S protein-microtubule trafficking and anti-inflammatory effects, Veru is evaluating the drug as a treatment for cytokine release syndrome (cytokine storm) induced by COVID-19.

• Veru announced that in a 29-day, 40 patient, Phase II trial, treatment with sabizabulin resulted in an 82% reduction in mortality, 73% reduction in ICU days and 78% reduction in ventilator days compared to placebo in hospitalized COVID-19 patients at high risk for ARDS.
• Interim results from a 150 patients enrolled in a 60-day, 204 patient, Phase III trial (NCT04842747), found that treatment with sabizabulin resulted in a 20.2% mortality rate compared to a 45.1% rate in hospitalized patients with moderate to severe COVID-19 at high risk for ARDS or death. Compared to placebo, treatment with sabizabulin resulted in a 43% reduction in ICU days, 49% reduction in ventilator days and 26% reduction in hospital days.