- A major mix-up at a Baltimore plant manufacturing Johnson & Johnson's coronavirus shot caused one batch of vaccine to fail quality control checks, reportedly contaminating material sufficient for up to 15 million doses.
- According to The New York Times, workers at the factory, run by contractor Emergent Biosolutions, accidentally conflated ingredients for J&J's vaccine with those for another, unauthorized shot developed by AstraZeneca. The site is also helping make AstraZeneca's vaccine.
- The error occurred before doses were finished and filled into vials, J&J said in a statement Thursday. The Emergent site is not yet approved to produce J&J's vaccine by the Food and Drug Administration, which is investigating the lapse in quality control.
The FDA's emergency authorization of J&J's vaccine late last month boosted the quickening rollout of vaccines in the U.S., adding a third option in addition to shots from Pfizer and Moderna.
Yet, previous delays in manufacturing meant J&J only had 4 million doses ready to ship upon clearance, and the drugmaker only just met its target of delivering 20 million doses to the U.S. this month. Those doses were shipped from J&J's own plant in the Netherlands, not the Emergent plant responsible for the most recent setback in supply.
While J&J on Thursday reiterated its goal of delivering 100 million doses for the U.S. by the end of May, the mistake by Emergent could put that target at risk or, at least, make it more difficult to achieve. Future shipments were expected to come from Emergent's Baltimore plant and will now be on hold, according to the Times and Politico.
In response, J&J is dispatching more specialists in vaccine manufacturing and quality control to oversee operations at Emergent's facility. Those steps, J&J said, will allow the company to "safely deliver" 24 million more doses through April. J&J would need to ship 66 million doses in May to meet its target, more than either Pfizer or Moderna has distributed in any one month to date.
Drug manufacturing, especially of biologic medicines like vaccines, is a complex, multi-step process reliant on careful controls to ensure a consistent and uncontaminated final product. Scaling production from smaller batches used to support clinical trials to bigger ones needed for large-scale commercial distribution can be particularly tricky, and it's not uncommon for there to be hitches in that process.
In an emailed statement, Emergent said it isolated the batch in question and will dispose of it properly. "The quality control systems worked as designed to detect and isolate this single batch," Emergent said.
The company's mistake, though, is particularly costly as well as embarrassing to J&J, a major multinational drugmaker and experienced vaccine developer that's staked more than a billion dollars to its coronavirus shot.
Only 3.3 million of the nearly 7 million doses of J&J's vaccine already delivered to states have been administered, according to data from the Centers for Disease Control and Prevention. By comparison, nearly 77 million doses of Pfizer's shot and almost 70 million doses of Moderna's have been used.
Both Pfizer and Moderna are each producing more than 10 million doses a week, giving the U.S. a steady supply of nearly 100 million doses a month between the two companies. The Biden administration has set a goal of having 200 million doses administered by the end of the president's first 100 days in office.
For Emergent, the manufacturing mix-up is a significant setback and adds to gathering scrutiny of the company.
The Baltimore plant Emergent is using to make the vaccine, known as Bayview, was inspected by the FDA in April 2020, according to the Associated Press. While there, agency inspectors criticized the company for failing to properly train employees and failing to investigate data integrity concerns, records obtained by AP showed.
Other facilities run by Emergent in Massachusetts and in Maryland have fell afoul of FDA rules during inspections in previous years, the AP said. Emergent is also drawing attention for its aggressive lobbying for government contracts to supply its anthrax vaccine to the national stockpile of medical goods, which ran short of many needed supplies early on in the pandemic.
Emergent shares fell 13.5% on Thursday morning and have declined by more than 35% since mid-February.
Note: This story has been updated to include a statement from Emergent Biosolutions.