Scientists at the Food and Drug Administration said Wednesday that the single-shot COVID-19 vaccine developed by Johnson & Johnson is effective and prevents hospitalizations from the disease.
Johnson & Johnson also revealed new, encouraging data showing the vaccine may do a better-than-expected job at protecting patients against new variants of the virus that causes disease. At the same time, FDA experts said the company’s study, results of which were originally made public in a Jan. 29 press release, includes insufficient information to draw conclusions on efficacy in people older than 75.
Documents from the FDA scientists, as well as separate documents from Johnson & Johnson, were released ahead of a Friday meeting of an FDA advisory panel in which outside experts will discuss and then vote on the risks and benefits of the new vaccine. The panel, known as the Vaccines and Related Biological Products Advisory Committee, makes recommendations to the FDA; the agency is not required to follow them, but it generally does.
The J&J vaccine is the first vaccine to show efficacy given as a single dose. It also does not need to be kept frozen when being shipped, as the vaccines developed by Moderna and the team of Pfizer and BioNTech do. Both of those advantages could be profound when it comes to vaccinating as many people as possible, a key step in slowing the spread of SARS-CoV-2.
Overall in the study, the vaccine reduced cases of COVID-19 that were rated as moderate to severe by 66.1% when considering cases occurring at least 28 days after vaccination. There were 193 cases that occurred at least 28 days after vaccination in the placebo group and 66 in the vaccine group. As of Feb. 5, there were seven COVID-19 related deaths in the placebo group and none in the vaccine group.