Stocks for Johnson & Johnson and Emergent BioSolutions fell in early trading Thursday amid reports that about 15 million doses of J&J’s COVID-19 vaccine failed quality checks after an ingredients mix-up.
Emergent BioSolutions was down more than 13 points, or 14%, as it dealt with the fallout from the problem at its Baltimore facility.
Workers conflated ingredients from the J&J vaccine and a version from AstraZeneca, which also is being produced at the plant. Both vaccines use an adenovirus-vector — essentially an inactivated virus that introduces proteins in cells that create antibodies — but the versions’ ingredients aren’t interchangeable.
J&J, whose stock was down less than a point in midafternoon trading, said the Baltimore plant hasn’t produced any of the doses in use so far in the U.S.
Those were made in the Netherlands, as the Baltimore facility awaits regulatory clearance to produce doses.
Requiring just a single shot, the J&J vaccine is an efficient and easy-to-store tool in the effort against COVID-19.
Whether the contamination issue delays the rollout or amounts to a blip remains to be seen.
J&J said it plans to deliver on its promise of 100 million doses by the end of May and will beef up oversight at the Emergent BioSolutions plant.
“Quality and safety continue to be our top priority. Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine,” the company said.
But the hiccup is an embarrassment for J&J and a disgrace for Emergent, which according to The Associated Press faced a series of citations for poorly trained employees, cracked vials and mold around one of its facilities.
President Biden was scheduled to visit the Baltimore facility in mid-March but scrapped the visit shortly after The New York Times reported on the company’s outsized lobbying and influence over the nation’s medical reserve, the Strategic National Stockpile.
Mr. Biden instead gathered CEOs from J&J and Merck to tout a vaccine-producing partnership between the rival companies.
In a statement Thursday, Emergent BioSolutions said it isolated the problematic batch of “drug substance” that didn’t meet its standards and that it “will be disposed of properly.”
“Importantly, the quality control systems worked as designed to detect and isolate this single batch,” the company said. “Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.”
Emergent said it continues “to manufacture in support of our customers and the U.S. government, and we remain confident in our ability to meet the FDA requirements.”
“We are very proud of the role the Emergent team is playing in support of the response to COVID-19 and look forward to continuing to do our part to help stem this pandemic,” it said.