U.S. puts J&J in charge of plant that botched COVID vaccine, removes AstraZeneca

The United States has put Johnson and Johnson in charge of a plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca Plc from using the facility, a senior health official said on Saturday.

J&J said it was “assuming full responsibility” of the Emergent BioSolutions facility in Baltimore, reiterating that it will deliver 100 million doses to the government by the end of May.

The Department of Health & Human Services facilitated the move, the health official said in an email, asking not to be named due to the sensitivity of the matter.

AstraZeneca, whose vaccine has not been approved in the United States, said it will work with President Joe Biden’s administration to find an alternative site to produce its vaccine.

White House officials did not immediately respond to a request for comment.

The development, first reported by the New York Times, further hampers AstraZeneca’s efforts in the United States. The government has criticized the drugmaker for using outdated data in the results of its vaccine trial. It later revised its study.

Workers at the Emergent BioSolutions plant several weeks ago conflated ingredients for the J&J and AstraZeneca vaccines, the Times said earlier in the week. J&J said at the time the ruined batch had not advanced to the fill-and-finish stage.

The government’s move to have the facility make only the J&J single-dose vaccine is meant to avoid future mix-ups, the Times said, citing two senior federal health officials.

The top U.S. infectious disease doctor told Reuters on Thursday the country may not need AstraZeneca’s vaccine even if it wins approval.

The United States has loan deals to send Mexico and Canada roughly 4 million doses of the AstraZeneca vaccine, made at its U.S. facility.

Fauci says U.S. may not need AstraZeneca COVID-19 vaccine

The United States may not need AstraZeneca’s COVID-19 vaccine, even if it wins U.S. regulatory approval, Anthony Fauci, the nation’s top infectious disease doctor told Reuters on Thursday.

The vaccine, once hailed as another milestone in the fight against the COVID-19 pandemic, has been dogged by questions since late last year, even as it has been authorized for use by dozens of countries, not including United States.

Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said the United States has enough contracts with other vaccine makers to vaccinate its entire population, and possibly enough for booster shots in the fall.

Asked whether the United States will use the AstraZeneca vaccine doses, he said, “That’s still up in the air. My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfill all of our needs without invoking AstraZeneca.”

Late last year, the drugmaker and Oxford University published data from an earlier trial with two different efficacy readings as a result of a dosing error. Then in March, more than a dozen countries temporarily suspended the use of AstraZeneca’s vaccine after reports linked it to a rare blood clotting disorder.

Also in March, a U.S. health agency said data from the company gave an incomplete picture of its efficacy. Days later AstraZeneca published results showing diminished, though still strong, efficacy.

Fauci said that “If you look at the numbers (of doses) that we’re going to be getting, the amount that you can get from J&J, from Novavax from Moderna if we contract for more, it is likely that we can handle any boost that we need, but I can’t say definitely for sure.”

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