An FDA report released Wednesday indicates that Johnson & Johnson’s single-shot COVID-19 vaccine is safe and effective, setting the stage for its potential approval and distribution in the coming days.
Initial results released by Johnson & Johnson earlier this month indicated that the vaccine reduced severe instances of the disease by 85 percent, and no person who took the vaccine died as a result.
The findings also found that the vaccine was 66 percent effective in completely preventing the disease. The two vaccines that have been approved for emergency use both showed to be more than 90% effective in preventing all cases of the disease.
According to the Washington Post, FDA scientists found that the vaccine efficacy against severe infections of the virus “was similarly high across the United States, South Africa, and Brazil.”
The Johnson & Johnson trial took place, in part, in South Africa, where a variant strain of the virus is dominant. While that strain is thought to be more transmissible, the virus was still 57 percent effective in reducing moderate to severe illness and 89 percent effective in preventing severe illness.
“We know this vaccine prevents 85 percent of the severe disease. … It was 100 percent effective in preventing hospitalization and deaths, and that’s really what’s important,” Nancy M. Bennett, a professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry, told the Washington Post.
The Johnson & Johnson vaccine candidate would clear many of the logistical hurdles presented by vaccines made by Pfizer and Moderna.
Johnson & Johnson's vaccine requires only a single shot, which would help alleviate stockpile concerns. It also does not need to be stored at ultra-cold conditions like other COVID-19 vaccines, making it easier to ship while driving down costs.
The release of the FDA’s report comes two days before the department’s Vaccines and Related Biological Products Advisory Committee will meet to discuss granting emergency approval for the vaccine.
Should that panel formally recommend it be approved for Emergency Use, the Centers for Disease Control and Prevention could give final approval as soon as this weekend.
During a briefing on Wednesday, White House COVID-19 response team coordinator Jeff Zients said that if the FDA grants emergency use authorization to the vaccine, the federal government expects to deliver between 3 and 4 million doses to states by next week. He added that Johnson & Johnson has committed to delivering 20 million doses to the federal government by the end of March.
