J&J announced that in the 43,783 patient, Phase III, ENSEMBLE trial (NCT04505722), a single immunization with their COVID-19 vaccine resulted in 66% efficacy based on 468 cases of moderate to severe COVID-19 that developed in the study population. There were regional variations with efficacy measured as 72% in the United States (44% of the study population), 66% in Latin America (41% of the population) and 57% in South Africa (15% of the population). The vaccine was 85% effective in preventing severe disease. 34% of the study population was over the age of 60. The study population also included 19% who identified as Black or African American, 45% Hispanic or Latino, 9% Native American and 3% Asian. 41% of the population had a risk factor to develop severe COVID-19. J&J stated the vaccine was well tolerated but did not provide details of adverse events.
Novavax announced that in a 15,000 patient, Phase III trial (NCT04583995), two doses of NVX-CoV2373 given 21-days apart resulted in 89.3% efficacy based on 62 cases of moderate to severe COVID-19 that developed in the United Kingdom study population. Efficacy was 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain.
Novavax announced that in a 4,400 patient, Phase IIb (NCT04533399) two doses of NVX-CoV2373 given 21-days apart resulted in 60% efficacy based on 44 cases of moderate to severe COVID-19 that developed in the South African study population. Efficacy was decreased due to the South Africa variant strain. In an analysis of 27 of the COVID-19 cases, the mutated virus was present in 92.6% of cases.
NIH announced the initiation of a 30,000 patient, Phase III, PREVENT-19 trial (NCT04611802) to evaluate the safety and efficacy of NVX-CoV2373, a COVID-19 vaccine from Novavax. Two vaccinations will be given 21-days apart. In late January 2021, Novovax announced they had enrolled over 16,000 patients in a 30,000 patient PREVENT-19 trial in the U.S. and Mexico.
Novovax initiated development of a vaccine to combat COVID-19 variants in January 2021 and plans to use the candidate in a bivalent vaccine or booster vaccine.
Lilly announced that in the 29-day, 1,035 patent, Phase III portion of the BLAZE-1 trial (NCT04427501), 2.1% of patients treated with bamlanivimab 2800 mg plus etesevimab 2800 mg experienced the primary endpoint of COVID-19 related hospitalizations or death compared to 7% that received placebo in patients with mild to moderate COVID-19 who were at high risk for progressing to severe COVID-19 and/or hospitalization. No deaths occurred in the combination treatment group compared to ten deaths in the placebo group.
Lilly is comparing bamlanivimab alone, and bamlanivimab and etesevimab together, at various doses, versus placebo in the reduction of viral load in the 7-day, 1,000 patient, Phase II BLAZE-4 trial (NCT04634409). Initial data suggests that lower doses of bamlanivimab and etesevimab may be effective. BLAZE-4 will also evaluate the combination of Lilly’s bamlanivimab in combination with Vir’s and GSK’s VIR-7831.
Regeneron announced preliminary results from 409 patients enrolled in an NIAID sponsored, 2,000 patient, Phase III trial (NCT04452318), where treatment with casirivimab and imdevimab prevented symptomatic infection in all 186 patients compared to 8 symptomatic infections in 223 patients who received placebo in COVID-19 negative patients exposed to a COVID-19 patient in the same household. A combination of symptomatic and asymptomatic infection developed in 10/186 that received casirivimab and imdevimab compared to 23/223 that received placebo.
An unpublished and unedited invitro study that tested the ability of antibodies to neutralize pseudoviruses with new variant mutations of COVID-19 found that while there was some decrease in activity with convalescent plasma from recovered patients and vaccinated patients, the antibodies still were able to neutralize the pseudoviruses. The pseudoviruses were resistant to the activity of single monoclonal antibodies, but when two antibodies with different sites of action were combined, neutalization activity was maintained.
An unpublished and unedited invitro study that tested the antiviral effects of plitidepsin, ralimetinib and remdesivir on early SARS-CoV-2 and the B.1.1.7 variant found similar activity with both viral strains.