COVID-19 Update #56 for 12/4/2020

COVID-19 Vaccines
 
The British Medicines and Healthcare products Regulatory Agency (MHRA) approved the COVID-19 vaccine from Pfizer and BioNTech on 12/2/2020. The U.K. signed an agreement with Pfizer and BioNTech for 40 million doses of the vaccine. The vaccine will start to be distributed immediately with delivery to be completed in 2021 as vaccine supplies become available. 
 
The FDA’s Advisory Committee on Immunization Practices recommended that health care providers and long-term care residents be the first to be immunized for COVID-19. Health care providers includes those who work in hospitals, outpatient clinics, long-term care facilities, home health, public health, emergency medical services and pharmacies.
 
COVID-19 Antivirals
 
Interim results from the WHO sponsored, 11,330 patient, Phase II/III SOLIDARITY trial (NCT04315948), did not find an improvement in hospitalized COVID-19 patients treated with remdesivir, hydroxychloroquine, lopinavir or interferon compared to no drug in mortality, initiation of ventilation or duration of hospital stay. But some analysts did not agree with the study’s findings. A physician reviewer speculated that remdesivir may be more effective when given early in the infection to patients at high risk for progression. An editorialist highlighted the benefit of remdesivir“to change the course of hospitalization in some patients”. A second editorialist pointed out that SOLIDARITY was not designed to measure time to recovery or clinical improvement.
 
COVID-19 Anti-inflammatories
 
Remestemcel-L is a Mesenchymal Precursor Cell (Stem cell therapy) being developed by Mesoblast for the treatment of Acute Graft Versus Host Disease following allogeneic bone marrow transplantation. Remestemcel-L decreases pro-inflammatory cytokines, increases anti-inflammatory cytokines, and increases recruitment of naturally occurring anti- inflammatory cells to involved tissues. Due to these properties, Mesoblast is evaluating remestemcel-L to reduce cytokine storm in acute respiratory distress syndrome (ARDS) due to COVID-19 infection. 

• The FDA granted remestemcel-L, a Fast Track designation for the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19 infection.