Full US FDA Independent Review Of Janssen Booster Data May Not Continue Post-EUA
The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.
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Emergency use authorization for Pfizer/BioNTech, Moderna vaccine boosters for everyone ≥18 years was based on the same immune response data that supported previous clearance in certain high-risk groups, although FDA said it also considered additional real-world data on myocarditis risk and the recent increase in COVID-19 cases.
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.