COVID-19 Update #60 for 12/21/2020

​COVID-19 Vaccines
 
An FDA review of clinical data for Moderna’s COVID-19 vaccine found evidence supporting 94.1% efficacy and no major safety concerns. An age specific breakdown of efficacy found the vaccine to be 95.6% efficacious in patients under 65 and 84.6% efficacious in those 65 and older. Efficacy was consistent across race and ethnicity demographics. The most common ADR were mild-to-moderate pain at the injection site, fatigue, headache, muscle pain, joint pain and chills. Three vaccine recipients and one placebo recipient experienced Bell’s palsy, so the FDA has recommended ongoing monitoring for Bell's once widespread vaccination begins. On 12/17/2020, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 20-0, with one abstention to recommend an emergency use authorization for mRNA-1273 as prophylaxis for COVID-19 infections for patients 18 years and older. On 12/18/2020, the FDA granted an Emergency Use Authorization (EUA) for Moderna’s COVID‐19 Vaccine for the prevention of COVID-19 for individuals 18 years of age and older. Vaccine Fact Sheets are available for Healthcare Providers and Vaccine Recipients/Caregivers. The CDC's Advisory Committee on Immunization Practices (ACIP) voted 11-0, with three recusals to recommend use of Moderna’s vaccine on 12/19/2020. The CDC approved use of any full extra doses contained in the vials.
 
The CDC has provided interim clinical considerations for the Pfizer-BioNTech and Moderna COVID-19 vaccines. 

• Delay vaccination of patients with an acute COVID-9 infection until the patient has recovered. Immunization may be delayed for up to 90 days.
• Patients that have received convalescent or COVID-19 antibodies should have their immunization delayed for 90 days.
• Immunocompromised, autoimmune or pregnant patients with no contraindications, may receive the vaccine. Potential risks should be discussed with the patient, such as the unknown vaccine safety profile and effectiveness in immunocompromised populations, as well as the potential for reduced immune responses.
• Patients with a history of anaphylactic reactions should be observed for 30 minutes after vaccination
• Patients with a history of allergic, but not anaphylactic reactions should be observed for 15 minutes after vaccination
• No other vaccines should be given within two weeks of the Pfizer-BioNTech vaccine.
• The Pfizer-BioNTech and Moderna vaccines cannot be used interchangeably and the series should be completed with the vaccine the patients originally received. However if two doses of different products are inadvertently administered, no additional dose should be given of either vaccine.
• Patients with a history of Guillain-Barré syndrome or Bell’s palsy may receive the vaccine.

 
Johnson & Johnson announced completion of enrollment in the 45,000 patient, Phase III, ENSEMBLE trial in mid-December 2020. J&J estimates interim data to be available at the end of January 2021 and a request for an Emergency Use Authorization in February 2021.
 
COVID-19 Anti-Inflammatories
 
Mesoblast announced interim data from 180 patients enrolled in a 30-day, 300 patient, Phase III trial (NCT04371393), where treatment with remestemcel-L did not reduce all-cause mortality compared to placebo in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. The Data Safety Monitoring Board (DSMB) estimated the trial is unlikely to achieve a 43% reduction in mortality at the target enrollment. The DSMB recommended the trial be completed with the currently enrolled 223 patients. No safety concerns were detected in the interim analysis.