FDA panel recommends booster shot of Johnson & Johnson vaccine © Getty Images A Food and Drug Administration (FDA) advisory committee voted to recommend authorizing a second dose of Johnson & Johnson's COVID-19 vaccine. The agency's vaccine advisory committee voted unanimously, 19-0, to recommend authorization of a second dose as early as two months after the primary shot for anyone ages 18 and older. Unlike the authorizations for boosters for the Pfizer-BioNTech and Moderna vaccines, no restrictions were put on the J&J booster. The panel said that the J&J vaccine, like the other vaccines, requires two doses to be effective, though there was some heated debate as to whether the J&J vaccine was actually a two-dose shot, rather than a single dose with a booster. Johnson & Johnson representatives told the panel that a second dose given either two months or six months after the first shot increased antibody levels, but a single dose of the vaccine continued to offer protection. Data concerns: Committee members expressed concern with the quality of data presented by the company, because there were ultimately only 17 people included in an analysis, who were followed for six months. But at the same time, many said they felt like additional shots should be made available. "If the vaccine isn’t adequate, then it should be boosted in everybody,” said Eric Rubin editor-in-chief of The New England Journal of Medicine. “I’m not sure why you’re asking for an indication that would apply to millions of patients with a data set that includes 17 patients,” he said. Still, the vote and subsequent FDA action will likely add some clarity to the path forward for the 15 million people who received a Johnson & Johnson vaccine. What's next: The recommendation will now be taken up by the FDA, which could make a decision within days. A Centers for Disease Control and Prevention panel meets on the issue next week. Read more here. |
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