Trial results
The data is based on nearly 44,000 participants across eight countries with 468 cases of COVID-19. The study evaluated the efficacy of the vaccine candidate against moderate to severe COVID-19 with endpoints of 14 and 28 days after vaccination. The protective effects were visible as early as day 14. Protection levels varied across regions with US showing 72%, Latin America 66% and South Africa 57%, 28 days after vaccination.
The vaccine candidate displayed an efficacy rate of 85% in the prevention of severe disease among all adult patients across all regions, 28 days after vaccination, with the level of efficacy increasing over time, resulting in no cases being reported after day 49 in vaccinated participants. The vaccine candidate also displayed complete protection against COVID-related hospitalization and death, 28 days after vaccination.
The results from the ENSEMBLE study also showed that the vaccine candidate was effective against the newly emerging strains of coronavirus, including some of the highly infectious variants seen in regions like the US, South Africa and Latin America.
J&J plans to file for approval in the US in early February and expects to have the product ready to be shipped as soon as it gets approved.
Vaccine technology
J&J’s COVID-19 vaccine uses its AdVac viral vector technology to generate strong, long-lasting immune responses. The AdVac vaccine platform was used in the production of the company’s Ebola vaccine and is also being used to develop vaccines against Zika and HIV.
Storage and distribution
The company said its vaccine candidate is compatible with standard vaccine distribution channels. It can be stored for two years at a temperature of -20°C and for three months at refrigerator temperatures of 2-8°C. J&J will ship the vaccine using its current cold chain technologies.
Competition
Pfizer (NYSE: PFE) and Moderna (NASDAQ: MRNA) have already rolled out their vaccines in the market and both have efficacy rates of 95%. On Thursday, Novavax (NASDAQ: NVAX) reported that its vaccine candidate was 89% effective in preventing COVID-19 disease.
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