Johnson & Johnson's COVID-19 Booster Dose Wins FDA Adcomm Backing

The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-0 to authorize a second shot of Johnson & Johnson's JNJ COVID-19 vaccine to follow at least two months after the initial dose.
Related Link: Johnson & Johnson COVID-19 Booster Shot Generates 9X Spike-Binding Antibodies, Early Data Shows.
The vote came after Janssen presented data from multiple studies suggesting a second shot provides a significant boost in efficacy compared to the single-dose regimen, including one trial that demonstrated a roughly 94% efficacy rate against moderate and severe infection in the U.S.
The submission also included data from a real-world study that demonstrated the effectiveness of 76% for COVID-19-related infections and 81% for COVID-19-related hospitalizations, with no evidence of reduced effectiveness over six months – including when the Delta variant.
J&J had administered more than 15.2 million doses of its vaccine. Because data wasn't readily available, it is uncertain how many of these recipients will be immediately eligible to receive a second dose of the vaccine.
Price Action: JNJ shares are down 0.01% at $161.28 during the premarket session on Monday's last check.
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