Johnson & Johnson production error ruins 15m COVID-19 Vaccine doses

*Report indicates though drug maker and vaccine producer Johnson & Johnson’s COVID-19 is keen on accelerating COVID-19 Vaccine supply, Astra Vaccine ingredient was mixed in by accident resulting in a manufacturing error at a plant in the US

Isola Moses | ConsumerConnect

Though the company reportedly downplayed the situation and said it met its most recent vaccine delivery target, a manufacturing error at a plant involved in COVID-19 Vaccine production has affected 15 million doses worth of an ingredient for the Johnson & Johnson (J&J) Vaccine.

The issue, which occurred recently at an Emergent BioSolutions Incorporated facility in Baltimore, in the United States (US), is not expected to change President Joe Biden’s expectation that the country will have enough vaccine for all adults May 2021, New York Times (NYT) reported Wednesday, March 31.

ConsumerConnect, however, gathered that none of the doses produced and shipped so far in the US have come from that plant, which is not authorised yet, two administration officials said on condition of anonymity.

COVID-19 Vaccines    Photo: Fox8.Com

J&J in a e-mailed statement rather said a batch of drug substance failed its quality test.

Workers there accidentally conflated ingredients belonging to the J&J vaccine and another manufactured on the premises for AstraZeneca Plc, according to the report. How the issue may affect the US vaccine nationwide rollout is unclear.

But J&J, as of now, has produced by far the smallest supply of the US-authorised COVID-19 vaccines, report said.

The two other vaccine producers, Pfizer Inc. and Moderna Inc., met their first quarter targets of 120 million doses and 100 million doses respectively. Those vaccines require a two-dose regimen.

“This quality control process identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our Covid-19 vaccine,”

J&J Spokesman Jake Sargent in the statement said: “This batch was never advanced to the filling and finishing stages of our manufacturing process.”

It added that the drugmaker addressed the issue with Emergent and reported it to the Food and Drug Administration (FDA).

The Biden administration has touted J&J’s one-dose, refrigerator-stored Covid shot as an efficient way to confer protection to Americans, particularly those in hard-to-reach places.

Representatives for Emergent declined to comment, deferring to J&J’s statement. The White House also declined to comment, according to report.

Nonetheless, in terms of delivery target, New Brunswick, New Jersey-based J&J said it beat its March target, providing the US Government more than 20 million doses, and that it expects to deliver another 24 million by the end of April.

Much of that supply is coming from another contract manufacturer, Catalent Inc., which recently, was authorised to make the shot at a facility in Bloomington, Indiana.

Biden has set a goal for almost 100 million J&J doses by the end of May, a number that factors into his expectation that the US will have enough vaccine to cover all adults by then.

J&J disclosed Wednesday, March 31 that it still plans to deliver 100 million doses by the end of June, and is “aiming” to deliver them earlier, by the end of May.

But the problems at J&J’s manufacturing partner suggest that US vaccination goals are vulnerable to events out of the government’s control.

Johnson & Johnson is now expanding its presence in the Emergent facility, as it will provide additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support the making of its vaccine, report added.

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