For the first time, a single-dose COVID-19 vaccine has been shown to deliver solid protection against severe disease and death. The vaccine, made by Johnson & Johnson (J&J), had 85% efficacy against COVID-19–related fatalities or severe symptoms in all age groups, regardless of a person’s other underlying medical conditions, the company announced today. Its efficacy against mild cases of the disease was lower, and dropped to 57% in South Africa, where a viral variant that can dodge immune responses now dominates. But when it came to severe disease, the vaccine appeared equally effective regardless of the viral strain, a result many vaccine experts hailed.
“If you can prevent severe disease in a high percentage of individuals, that will alleviate so much of the stress in human suffering and death in this epidemic,” said Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, at a telephone press conference this morning. Nahid Bhadelia, an infectious disease physician who is medical director of the special pathogens unit at Boston Medical Center, added that a single-dose vaccine could be a boon for people living in remote places and those who might have difficulty getting a second dose. Given the data against mild disease, “Someone is going to say that the [J&J] results are disappointing,” Bhadelia says, but they’re “a game changer.”
The 85% efficacy against severe disease everywhere in the multicountry trial rose to 100% protection when only considering deaths or COVID-19 cases that required hospitalization. To many vaccine experts, that is the key result. “Do you want a vaccine that prevents coughs or do you want a vaccine that prevents death?” asks Lawrence Corey of the University of Washington, Seattle, who co-leads a clinical trials network in the United States that is testing this vaccine and others that received support from the U.S. government’s Operation Warp Speed. The J&J results come less than 24 hours after another COVID-19 vaccine success reported by the small biotech Novavax. “What I take away from this week is that we have two more tools in our toolbox at a very precarious time,” Bhadelia says.
The J&J vaccine, which was developed by its Janssen Pharmaceuticals division, contains a gene for the SARS-CoV-2 spike protein stitched into adenovirus 26 (Ad26), which normally causes common colds but has been disabled so that it cannot replicate. This trial includes nearly 44,000 people in the United States, Latin America, and South Africa. The interim analysis announced today, described only in a press release so far, found 468 cases of symptomatic COVID-19 among the participants—far more than any other COVID-19 vaccine efficacy trial to date, which provides more confidence that the results are robust. Some protection was seen as early as 14 days after the dose, and by day 28, the overall efficacy against COVID-19 cases with any noticeable symptoms was 72% among trial participants in the United States, 66% in Latin America, and 57% in South Africa, the company said. No serious safety issues surfaced.
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Originariamente Scritto da Skynight
