FDA panel determined Friday that Johnson & Johnson’s vaccination should be designated a two-dose vaccine rather than the one-and-done shot that had won initial approval.
The committee believed that all 15 million Americans who received a single dose of the “one and done” J&J vaccination would be significantly better protected if they received a second one.
The Vaccines and Related Biological Products Advisory Committee reached a unanimous judgement after real-world data revealed that J&J’s one-shot vaccination is not as effective as the Pfizer and Moderna vaccines in real-world tests.