COVID-19 Update #51 for 11/13/2020

COVID-19 Vaccines
 
An unpublished report describes interim data from a 248 patient, Phase I dose ranging trial (NCT04449276), where two 12 mcg doses of CureVac’s COVID-19 vaccine, CVnCoV, elicited antibody levels similar to levels seen in a group of recovered COVID-19 patients. In the Phase I trial, healthy patients were randomized to doses of 2, 4, 6, 8 and 12 mcg on days 1 and 29. The 12 mcg dose was chosen for future trials. Most adverse events were mild or moderate. The most common were headache and fatigue, myalgia, chills and fever.
 
The FDA granted Novavax’s COVID-19 vaccine, NVX-CoV2373, a Fast Track Designation for the prevention of COVID-19.
 
Once approved Pfizer will ship initial supplies of their vaccine directly to hospitals, clinics, pharmacies and other points of vaccination, rather than distribute it through McKesson. The extreme temperature required for the vaccine caused Pfizer to decide on direct shipments. The vaccine must be kept at -70 to -80 C. Pfizer will ship the vaccine in boxes that can keep the vials at -70 C for 10 days. The dry ice in the shipping container can be refilled with dry ice to keep the vaccine cold for facilities that do not have freezers that can maintain a -70 to -80 C temperature. Healthcare facilities that plan to use the cold-pack shipping containers to store the vaccines should make sure they have a reliable source for replacement dry ice.
 
Medicago is developing a virus-like particle vaccine (CoVLP). The virus-like particles are created in genetically modified plant cells. Medicago has signed an agreement to provide 76 million doses to Canada.

• Two doses of CoVLP are given with GSK’s vaccine adjuvant 21 days apart.
• In an unpublished report of a 180 patient, Phase I, dose-ranging trial, all patients given CoVLP with GSK’s adjuvant elicited neutralizing antibodies after a second dose of the vaccine. Based on results, the lowest dose (3.75 mcg) was chosen for a Phase III trial.
• Medicago will evaluate the safety and efficacy of CoVLP in a 30,000 patient, Phase II/III trial. ​
  

On 11/9/2020, Brazil halted a 9,000 patient, Phase III trial, examining the safety and efficacy of Sinovac’s CoronaVac to investigate a serious adverse event. The trial was allowed to resume on 11/11/2020 after additional information on the event was provided to Brazilian health authorities.
 
The Russian National Research Center for Epidemiology and Microbiology claims the Sputnik V vaccine is 92% effective, based on the distribution of 20 cases of COVID-19 among 16,000 volunteers (Note: Pfizer based their 90% effectiveness on 94 cases distributed among 39,000 patients, other vaccine manufacturers are waiting until there are at least 50 cases).
 
COVID-19 Monoclonal Antibodies
 
HHS announced plans for distribution of bamlanivimab. Like the earlier program for remdesivir, weekly supplies of bamlanivimab will be distributed to states based on reported COVID-19 cases. Each state health department will determine where and how much bamlanivimab to send to individual health care facilities.
 
COVID-19 Antivirals
 
A retrospective review of 280 COVID-19 patients from four Florida hospitals found lower mortality in patients treated with ivermectin compared to patients not treated with the drug (15.0% vs 25.2%). Most patients were receiving hydroxychloroquine, azithromycin, or both.
 
In a 28-day, 101 patient, Phase II trial (NCT04385095), patients treated with nebulized interferon beta-1a were twice as likely to have improved their WHO Ordinal Scale for Clinical Improvement by day 15-16 and three times as likely by day 28 in hospitalized British patients with COVID-19.
 
In an 89 patient trial in Oman, favipiravir and nebulized interferon beta-1b did not improve time to recovery, decrease in inflammatory markers nor improvement in oxygenations compared to hydroxychloroquine in hospitalized patients with moderate to severe COVID-19 pneumonia. Almost all patients also received antibiotics, one-third received tocilizumab, two-thirds received a corticosteroid and over half received convalescent plasma.