Johnson & Johnson applies for US approval for booster shots

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Drugmaker Johnson & Johnson (J&J) has applied to the U.S. Food and Drug Administration (FDA) for approval of booster shots of its coronavirus vaccine for people 18 and older. In-house studies have shown that booster vaccination increases the vaccine’s protective efficacy to 94 percent, Mathai Mammen, head of research and development at J&J subsidiary Janssen, said yesterday.

Unlike other vaccines, one dose is officially enough for J&J’s vaccine. The U.S. clinical trial showed that a second dose injected about two months (56 days) after the first dose was 94 percent effective against moderate-to-severe cases and 100 percent effective against severe cases 14 days after the second injection, according to the group.

FDA to meet in mid-October
At the same time, Mammen stressed that a vaccine like J&J’s, of which only one dose is needed for “long-term protection,” “represents a critical contribution to vaccinating the world’s population.” The vaccine has had emergency approval in the U.S. since February 2021 and has been given to 15 million people so far. That’s far fewer than the Biontech/Pfizer and Moderna vaccines.

The FDA said its expert committee would meet Oct. 14 and 15 to review applications from Johnson & Johnson and competitor Moderna.

  • source: ORF.at/agencies/picture: zdf.de

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