J&J Offers Sliding Timeframe for Covid Boosters Based on Individual Patient and Geographic Need
Johnson and Johnson’s one-shot Covid vaccine gets a solid efficacy boost with second shot administered two months after primary vaccination, but the company will argue based on much more limited data that a longer window between shots may be preferable for some populations.
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After US FDA authorization for additional COVID vaccine shots, the focus now shifts to CDC’s advisory committee, which may be concerned about variations in eligible populations, timing and dosing when it comes to giving a booster different from the primary vaccination series.
Advisory committee members say clinical data proves the second shot should be considered part of the primary series, while Janssen wants it called a single-shot vaccine with a booster.
Agency assessors couldn’t independently verify several Janssen analyses of booster shot data and raised concerns about small samples sizes and an unvalidated immunogenicity assay.