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Janssen Biotech Inc.

http://www.janssenbiotech.com

Latest From Janssen Biotech Inc.

Janssen Gets US FDA Panel Nod For Additional COVID Vaccine Shot – But Is It A ‘Booster’?

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.

Vaccines Coronavirus COVID-19

Moderna's COVID-19 Vaccine Booster US FDA Panel Nod Driven By Pragmatism

Despite lack of enthusiasm with immunobridging study data, the panel endorsed emergency use in certain at-risk populations, in part because it would be hard to turn down the Moderna booster when an identical EUA had been issued for Pfizer/BioNTech's mRNA vaccine.

Coronavirus COVID-19 Vaccines

Janssen Booster Evidence Draws Questions From US FDA, But Also A Nod Towards Benefits

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.

Vaccines Advisory Committees

Moderna COVID-19 Vaccine: Booster Study Hits Only One Of Two Immunogenicity Endpoints

Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.

Advisory Committees Coronavirus COVID-19
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