Johnson & Johnson applied to give COVID-19 booster shots 6 months after the first was administered.
But the FDA isn't convinced there's enough data yet to back a J&J booster shot.
An FDA expert panel will vote Friday on if the agency should OK J&J booster shots.
Johnson & Johnson wants to give people who received one dose of its COVID-19 vaccine a second dose, but it's unclear if the US Food and Drug Administration is onboard.
In documents released Wednesday, the FDA pointed out several key limitations in the evidence that J&J submitted for a booster shot. The agency is currently reviewing J&J's application to give an extra dose as early as two months after the single-shot jab. An FDA expert panel will meet Friday to discuss and vote on J&J's booster application.
In particular, the agency highlighted the lack of robust clinical trial results supporting giving a booster six months following the first dose. J&J submitted results from a study that included just 17 volunteers who got a second dose after six months. While that data appeared to meet the FDA's goals for what a booster should do, the agency said the results are limited by the small sample size and were also impacted by the low sensitivity of a lab test J&J used.
J&J argued for a booster six months after the initial shot in its own report released Tuesday.
"A booster dose is recommended at 6 months or later, based on the strength of the immune responses," the company wrote, while adding it wanted to make a booster available as early as two months after the first shot.
There's far more evidence supporting a second dose of J&J given two months after the first shot. But that dataset, which includes more than 16,000 volunteers, has yet to be independently reviewed and verified by by FDA scientists, the agency said.
Now, 15 million American who got J&J's vaccine are left wondering if and when a booster could be available. It's also unclear if the agency will consider authorizing Pfizer's or Moderna's shot for J&J recipients as well.
Despite the limitations highlighted by the FDA's review, it's still possible the agency will OK J&J's booster shot. Data has shown J&J recipients are less protected against hospitalization and death than people who got Moderna and Pfizer.
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