Johnson & Johnson's single-dose COVID-19 vaccine effective, safe: FDA analysis

Source: The Hill | February 24, 2021 | Nathaniel Weixel

Johnson & Johnson’s single-dose coronavirus vaccine is effective at preventing moderate and severe cases of COVID-19, according to an analysis of the trial data published by the Food and Drug Administration on Wednesday.

The company’s single dose vaccine is 66 percent effective, well within the agency’s standards. The vaccine is also safe to use, according to the analysis.

More specifically, the vaccine is more than 85 percent effective at preventing severe cases of COVID-19, and completely prevents hospitalizations and deaths.

Overall, there were seven deaths in the trial, all in the placebo group.

The company initially announced the 66 percent effectiveness in a press release last month but had not yet released trial results.

The information was published ahead of an FDA advisory committee meeting Friday, which will debate whether to grant the vaccine emergency authorization. The promising data give hope that a third coronavirus vaccine could be authorized as soon as this weekend.

While the other coronavirus vaccines already on the market may appear to be more effective than J&J’s, experts say it is difficult to compare them head-to-head.

The vaccine was tested in a 44,000 person clinical trial across the U.S., Brazil and South Africa, geographic regions, all of which have seen mutated versions of the virus. 

There was a lower efficacy against moderate to severe/critical disease endpoints observed in South Africa compared to the United States and Brazil, but vaccine efficacy against severe or critical COVID-19 infections was “similarly high in all 3 countries,” the review found.

Still, the varying efficacy is a warning sign about mutations, especially from the variant found in South Africa. The effectiveness against moderate to severe illness dropped from 72 percent in the United States to 57 percent in South Africa, where a new coronavirus variant is prevalent.

The vaccine was less effective in a subgroup of adults older than 60 with underlying conditions, but regulators noted there were no deaths or cases requiring medical intervention a month after those older adults received vaccines.

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  •  Consistent #47662

     EVERYDAY #47663

    From what I’ve read, J&J’s vaccine isn’t quite as effective as Pfizer’s and Moderna’s. But I’m thinking it might be good enough for the young and healthy. Maybe with a third vaccine available, we can move inoculation along quicker than at the snail’s pace it’s been.

     Consistent #47700

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