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Full US FDA Independent Review Of Janssen Booster Data May Not Continue Post-EUA

Executive Summary

The agency said its booster EUA decision was based on the immunogenicity studies that were submitted.

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EU Approval In View For Novavax COVID-19 Vaccine; EMA OKs Janssen Booster

It’s all go on the EU coronavirus front this week: three new therapies and another vaccine booster have been recommended for use, and a special session on the Novavax vaccine is to be held at the EMA next week. More production capacity has been OKd for three vaccines.

Same Data, Broader Use: COVID-19 mRNA Vaccine Booster Authorizations Expanded In US

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.

Moderna, Janssen And ‘Mix & Match’ Boosters Create A ‘Not Simple’ Array Of Dosing Options

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.

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