The Food and Drug Administration has told Johnson & Johnson that it must throw out at least 60 million doses worth of the COVID vaccine drug substance produced by subcontractor Emergent BioSolutions at its troubled plant in Baltimore over concerns it may have been contaminated, the New York Times reported Friday. Only two batches of J&J vaccine drug substance made at the facility, enough for roughly 10 million doses, have been cleared for use — albeit with with a warning regarding the problems at the facility. Other batches are still be evaluated.
Vaccine drug substance for more than 100 million J&J doses were made at the plant before it was shut down in late March, at which point Johnson & Johnson reported that it had to throw out 15 million doses worth of material as a result of a manufacturing mistake. Drug substance for 70 million doses of the AstraZeneca COVID vaccine was also made at the plant, and like the J&J doses, those doses have also been in regulatory limbo since the shutdown at the plant.
No doses made at the plant have been administered in the U.S.; all J&J doses distributed for use in the U.S. thus far were manufactured by the company at its plant in the Netherlands.
While the J&J one-shot vaccine is no longer considered an important part of the U.S. vaccine rollout, the discarded doses definitely could have been useful and important worldwide, since the vast majority of countries are still struggling to obtain vaccine supply to inoculate their populations against the coronavirus. Without much need for the J&J vaccine in the U.S. anymore, it seems likely that any doses produced by the Baltimore facility and cleared for use will only be administered abroad — particularly as the U.S. vows to do more to boost worldwide supply.
As the Times noted Friday, the whole situation with the Baltimore facility continues to be a mess:
The F.D.A.’s action is disappointing news for Emergent and Johnson & Johnson, which hired the firm as a subcontractor. Inspectors are still reviewing the plant and are not expected to decide whether the company can reopen it until later this month, according to people familiar with the situation. Regulators are also continuing to cast doubt on whether the company, which has been paid hundreds of millions of dollars by the federal government to manufacture coronavirus vaccines, adhered to manufacturing standards.
The agency’s plan to allow 10 million doses to be used in the United States or abroad with a warning is somewhat unusual for a product under emergency authorization, experts said. Regulators have the discretion to take that action if the drugs are badly needed and in short supply, they said
Administration of the J&J vaccine in the U.S. was temporarily paused in April so that regulators could investigate reports of an extremely rare blood-clot risk. Administration of the vaccine resumed less than two weeks later, but as of this week, a little more than half of the 21 million J&J doses distributed in the U.S. have been gone into arms.
The Wall Street Journal reported Thursday that the U.S. has suspended the shipment of new J&J doses since mid May, in what appears to be, at least in part, an effort to help use up unused doses before they expire. The FDA has also extended the shelf life of the J&J vaccine under normal refrigeration from three months to four and a half months.