Vials of Johnson & Johnson's Janssen coronavirus disease (COVID-19) vaccine. [Source: Reuters]
The U.S. government authorized Johnson & Johnson’s single-dose COVID-19 vaccine, enabling millions more Americans to be vaccinated in the coming weeks and setting it up for additional approvals around the world.
The U.S. Food and Drug Administration announced the emergency use authorization for adults aged 18 and older following Friday’s unanimous endorsement by the agency’s panel of outside experts.
In J&J’s 44,000-person global trial, the vaccine was found to be 66% effective at preventing moderate-to-severe COVID-19 four weeks after inoculation, and 100% effective in preventing hospitalization and death due to the virus.
“This is an emergency use authorization to really mitigate hopefully the devastating effects of the current pandemic,” Marion Gruber, the FDA’s director of the office of vaccines research & review, said during Friday’s advisory panel meeting.
There were very few serious side effects reported in the trial, which also offered preliminary evidence that the vaccine reduced asymptomatic infections. If that proves to be the case, it would mean COVID-19 vaccines may indeed reduce virus transmission as well as illness.
J&J’s vaccine is expected to be used widely around the globe because it can be shipped and stored at normal refrigerator temperatures, making distribution easier than for the Pfizer Inc/BioNTech SE and Moderna Inc vaccines, which are shipped frozen.
