Skip to Content

FDA memo shows why Johnson & Johnson vaccine was unusable

UNITED STATES (KBJR)-- An FDA memo that surfaced Friday outlines how an estimated 75-million doses of the J&J vaccine were rendered unusable.

Inspectors at the emergent Biosolutions facility cited crowded manufacturing areas, inadequate quality assurance, and lab controls as problems.

In February, the FDA rejected an estimated 60-million doses of the Johnson and Johnson single-dose vaccine after a review of the Baltimore facility.

Then in March, the New York Times reported that another 15-million vaccine doses were ruined by quality control issues identified by J and J.

As of last week, the FDA has now approved 10-million doses of the single-dose vaccine from the facility as being safe to use.

Going forward, J&J must continue to share all relevant manufacturing information with regulators from both the u-s and countries where the vaccine may be used.

Natalie Sopyla

Skip to content