[NYTIMES] 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 stopped the facility from making another vaccine, developed by AstraZeneca.The extraordinary move by the U.S. 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 mix-ups, 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
...... 46th president of the U.S. Former Senator-for-Life from Delaware, an example of the kind of top-notch Washington intellect to be found in the World's Greatest Deliberative Body.......
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 front man 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 F.D.A. 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.
|