Experts have estimated that initial supplies of a COVID-19 vaccine will only allow immunization of health care employees. A larger supply that will allow mass immunization may not be available until spring or summer 2021.
Russia has approved a COVID-19 vaccine after limited Phase I testing. The vaccine has been named Sputnik V. No clinical data has been made available. Two small clinical trials with a total of 76 patients are claimed to have been conducted which resulted in antibodies being produced. A larger trial is now being planned.
HHS and the BARDA awarded Moderna $1.5 billion for the first 100 million doses ($15 per dose) of its experimental COVID-19 vaccine, mRNA-1273, as part of operation Warp Speed. The U.S. has an option to acquire additional 400 million doses. Should the vaccine be approved, the Federal supply will be provided at no charge, but health care providers can charge for administration. The $1.5 billion is in addition to the $955 million provided to Moderna for vaccine development and manufacturing scale-up.
Novavax purchased Praha Vaccines and its Czech Republic vaccine factory. That plant has an annual capacity of one billion doses per year. Novavax signed an agreement with Fujifilm Diosynth Biotechnologies to manufacture its COVID-19 vaccine, NVX-CoV2373, in North Carolina and Texas. Novavax also signed contracts with AGC Biologics and PolyPeptide to help produce its Matrix-M adjuvant. Novavax feels it will have the capacity to produce two billion doses of the NVX-CoV2373 annually beginning in 2021.
AstraZeneca has agreements with Brazil, Argentina and Mexico to manufacturer AZD1222 to supply patients in Central and South America.
CanSino plans to initiate a 5,000 patient, Phase III trial in Saudi Arabia.
In a 96 patient, Phase I, dose ranging trial, (ChiCTR2000031809) patients received three immunization of adjuvant alone or Sinopharm’s COVID-19 vaccine at low, middle or high strengths (2.5 mcg, 5 mcg or 10 mcg). The second immunization was given at 28 days and the third vaccine was given on day 56. All vaccine doses elicited neutralizing antibodies 14 days after the third dose. In a 224 patient, Phase II, trial, (ChiCTR2000031809) patients received two immunization of adjuvant alone or 5 mcg of Sinopharm’s COVID-19 vaccine. The second immunization was given at 14 or 21 days. The vaccine elicited neutralizing antibodies 14 days after the third dose at levels greater than adjuvant alone. The researchers did not compare levels of antibodies to those seen in recovered patients. The researcher claim the levels of neutralizing antibodies in the ChiCTR2000031809 Phase I and II trials were similar to those seen in other COVID-19 vaccine trials. However, different patient populations and different methods to measure antibodies were used, so caution is needed in comparing the levels of neutralizing antibodies.
Vir plans to initiate a Phase II/III trial in August to evaluate VIR-7831 as a treatment for COVID-19.
Interim results from 60 patients enrolled in a Russian COVID-19 trial, suggested that on day 5, treatment with favipiravir cleared SARS-CoV-2 in 62.5% of patients compared to 30% of patients on standard of care. There was no difference in clearance by day 10 (92.5% vs 80%). Most patients in the standard of care group received hydroxychloroquine, chloroquine or lopinavir/ritonavir. Standard of care treatment was not described, but included antibiotics, anticoagulants and/or immunosuppressants, as well as symptomatic treatment. Body temperature normalized 2 days earlier with favipiravir (2 days vs 4 days), but there was no difference in chest CT scan.