- Johnson & Johnson will directly manage manufacturing of its coronavirus vaccine at a Baltimore factory run by contractor Emergent Biosolutions, assuming "full responsibility" for production there after a mix-up several weeks ago ruined enough drug material for millions of doses.
- In a statement Sunday, J&J said it would significantly increase the number of employees at Emergent's site, adding "dedicated leaders for operations and quality." The site, which Emergent still owns, is not yet approved for production by the Food and Drug Administration, meaning no doses made there have been distributed or administered in the U.S.
- The federal government had also contracted Emergent to make AstraZeneca's experimental coronavirus vaccine at the Baltimore factory, along with J&J's shot. As a result of J&J taking over control of production, however, manufacturing of AstraZeneca's vaccine will be relocated to other locations, the British drugmaker confirmed.
Emergent, a Maryland-based drugmaker that prior to the pandemic was principally known for its anthrax vaccines, played a significant role in the Trump administration's plans to ramp up vaccine production last summer.
In June, the U.S. government agreed to pay over $500 million to reserve manufacturing space at Emergent's three sites in Maryland through this year. The deal included another $85 million to help the company improve its capacity to "fill and finish" vaccine doses.
The Baltimore facility, known as Bayview, was central to those plans, and was later tapped to produce what's known as the "drug substance" for both J&J's and AstraZeneca's vaccines. (Drug substance is made into a finished drug product at a later production step that involves filling and finishing vaccine vials.)
Several weeks ago, however, workers at the site reportedly conflated ingredients for the two shots, ruining one batch of manufactured drug substance of J&J's vaccine. According the New York Times, the batch was sufficient to make up to 15 million doses of the shot.
Emergent's CEO, Robert Kramer, has denied workers mixed up ingredients, although neither he nor the company has specified what exactly caused the batch to fail production standards.
"It wasn't the case where an ingredient from one vaccine contaminated or impacted the other," Kramer said in an April 1 interview on CNBC. "It was more simply the fact that one production run, one batch of product, was determined to be inconsistent with our quality specifications of Emergent and J&J."
However it happened, the manufacturing error is a notable black mark for Emergent's reputation and a setback for the hastening vaccine rollout in the U.S., in which J&J's shot was expected to play a substantial role. The vaccine is given as one dose, rather than the two required for both Pfizer's and Moderna's currently authorized shots.
J&J still expects to deliver the 100 million doses it agreed to supply the U.S. by the end of May. The pharma company delivered 20 million in March and expects to ship out 24 million this month.
According to The New York Times and Politico, the Biden administration, concerned about the mix-up's impact on supply and potential effect on public perception, ordered J&J to take over at the Bayview site.
In doing so, the administration appears to be prioritizing J&J's vaccine over AstraZeneca's, which has not yet been submitted to the FDA for emergency clearance. While the British drugmaker's shot has been approved in dozens of other countries, U.S. regulators were waiting for results from a large clinical trial that only recently read out positive results.
The good news was marred by a communication mishap, however, that added to recent safety concerns in Europe, where a number of countries had stopped vaccinations following reports of a rare and unusual clotting disorder that in more than a dozen cases led to death.
As vaccinations with Pfizer's, Moderna's and J&J's vaccines mount in the U.S., it's not clear how much of a role AstraZeneca's shot would play even if authorized by the FDA later this month.
In a statement, AstraZeneca said it would "work with the U.S. government to identify an alternative location for domestic drug substance production" of its vaccine. The company uses a site in Ohio to fill and finish doses.