FDA clears some J&J vax doses after 75 million reportedly tossed

June 17, 2021

J&J’s global rollout of its COVID-19 vaccine is proving to be an ongoing struggle.

Although the FDA cleared a reported 14 millions doses of the vaccine, made at Emergent BioSolutions this week, millions more have been ruined.

First in March, about 15 million doses were tossed after it was discovered that material from the AstraZeneca vaccine, which was being produced at the same Emergent facility, was exposed to media from the J&J shot. 

Afterwards, the FDA shut down production at the plant and conducted an inspection that led to a Form 483 with a list of quality observations. The closure left millions of doses in limbo, and last week, The New York Times reported that Emergent was ultimately asked to trash another 60 million shots.

Although the FDA’s ongoing review of the finished vaccines have led to some being approved to enter the market, the agency has included a warning with the shots saying that it cannot guarantee Emergent followed good manufacturing practices when making them. 

Because the U.S. is already awash in vaccines and domestic demand is waning, most of the J&J shots were pegged for global distribution. But the manufacturing hiccups — along with concerns about rare blood clots — is causing some countries to turn them away. 

This week, South Africa said it would reject 2 million J&J shots due to concerns about possible contamination.

Meanwhile, Emergent is still sitting on millions of doses of the J&J shot while it waits for the FDA to finish its review and clear the company to restart production.