Johnson &Johnson COVID-19 vaccine 66 percent effective in preventing moderate to severe COVID-19: study

Johnson &Johnson's COVID-19 vaccine candidate was 66 percent effective overall in preventing moderate to severe COVID-19, 28 days after vaccination, the company announced on Friday.

The result was based on the Phase 3 ENSEMBLE study involving nearly 44,000 participants. The study, designed to evaluate the efficacy and safety of the vaccine candidate in protecting moderate to severe COVID-19, was conducted in the United States, Latin America and South Africa.

The level of protection against moderate to severe COVID-19 infection was 72 percent in the United States, 66 percent in Latin America and 57 percent in South Africa, 28 days post-vaccination, according to the company.

The company said it plans to apply to the U.S. Food and Drug Administration (FDA) for emergency use authorization to distribute the vaccine.

The vaccine candidate was 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older, according to the company. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49.

"These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response," said Paul Stoffels, vice chairman of the Executive Committee and chief scientific officer, Johnson &Johnson.

The ENSEMBLE study results include efficacy against newly emerging strains of coronavirus, including some highly infectious variants present in the United States, Latin America and South Africa, according to the company.

In last December, the FDA authorized two COVID-19 vaccine for emergency use in the United States, one developed by American drugmaker Moderna and the other developed by American drugmaker Pfizer in partnership with German company BioNTech.

Unlike the vaccines from Moderna and Pfizer that require two shots given weeks apart, the Johnson &Johnson vaccine is given as a single shot. Also, the Johnson &Johnson vaccine does not require ultracold storage.

The United States has recorded more than 25.86 million COVID-19 cases with over 435,000 related deaths as of Friday afternoon, according to the real-time count kept by Johns Hopkins University. Enditem