U.S. replaces plant leaders after mix-up ruins doses
The Biden administration on Saturday put Johnson & Johnson in charge of a Baltimore manufacturing plant that ruined 15 million doses of its COVID-19 vaccine, and moved to stop the facility from making another vaccine developed by Astrazeneca.
The extraordinary move by the federal Department of Health and Human Services will leave the Emergent Biosolutions facility solely devoted to making the Johnson & Johnson single-dose vaccine and is meant to avoid future mixups, according to two senior federal health officials.
Johnson & Johnson confirmed the changes, saying it was “assuming full responsibility” for the vaccine made by Emergent.
The change came in response to the recent disclosure that Emergent, a manufacturing partner to both Astrazeneca and Johnson & Johnson, accidentally mixed up the ingredients from the two different vaccines, which forced regulators to delay authorization of the plant’s production lines.
Federal officials are worried that the mix-up will erode public confidence in the vaccines, just as President Joe Biden is making an aggressive push to have enough vaccine doses to cover every American adult by the end of May.
At the same time, there is deep concern about the safety of the Astrazeneca vaccine, amid a health scare that has prompted some European countries to restrict its use.
Astrazeneca said in a statement that it would work with the Biden administration to find an alternative site.
The ingredient mix-up, and Saturday’s move by the administration, is a significant setback and public relations debacle for Emergent, a Maryland biotech company that has built a profitable business by teaming up with the federal government, primarily by selling its anthrax vaccines to the Strategic National Stockpile.
A spokesperson for Emergent declined to comment, except to say that it would continue making Astrazeneca doses until it receives a contract modification from the federal government.
Experts in vaccine manufacturing said that in the past, the FDA had a rule to prevent such mishaps by not allowing a facility to make two live viral vector vaccines, because of the potential for mix-ups and contamination.
The reorganization of the Baltimore plant is another setback for Astrazeneca, which unlike Johnson & Johnson does not yet have emergency authorization from the Food and Drug Administration for its vaccine. With three federally authorized vaccines (the other two are by Pfizer-biontech and Moderna) it is not clear whether the Astrazeneca vaccine, which has had a troubled history with regulators, could even be cleared in time to meet U.S. needs.
However, one of the federal officials said the Health and Human Services Department was discussing working with Astrazeneca to adapt its vaccine to combat new coronavirus variants.
None of the Johnson & Johnson doses made by Emergent have been released by the FDA for distribution.