J&J files for booster shot authorization. J&J submits data to the FDA.
Where: United States
The Facts
On October 5th, Johnson & Johnson (J&J) announced it had filed for emergency use authorization (EUA) of booster shots for its one-dose COVID-19 vaccine to the FDA.
J&J submitted data of a late-stage study conducted in the US that reported a 94% increase in protection levels against COVID-19 after receiving a booster shot 56 days after primary immunization.
The data also indicated participants showed 100% protection against severe disease after at least 14 days of receiving the J&J COVID-19 booster shot.
FDA’s Vaccine and Related Biological Products Advisory Committee is scheduled to meet on October 15th to review the data and decide on issuing a EUA for the J&J booster shot.
Global head of J&J’s Janssen unit, Dr. Mathai Mammen, stated, “We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters.”
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