Johnson & Johnson’s taking ‘full responsibility’ for COVID-19 Vaccine production error

*J&J is taking “full responsibility” after a major production error involving 15 million vaccine doses, as AstraZeneca Plc agrees to relocate manufacturing of its vaccine out of the Emergent BioSolutions Incorporated facility in Baltimore, United States

*But the Emergent vaccine facility is ‘not yet authorised’ by US regulator Food and Drug Administration

Gbenga Kayode | ConsumerConnect

In order to minimise the risk of another costly vaccine production blunder at the same plant, Johnson & Johnson (J&J) with help from President Joe Biden’s administration, is moving production of material for second company’s shots, and completely take over a vaccine production facility in Baltimore, United States (US).

ConsumerConnect had reported that the drug maker and vaccine manufacturer initially, had purportedly downplayed a serious manufacturing error at the Emergent BioSolutions Incorporated facility that had ruined 15 million doses worth of an ingredient or drug substance for its COVID-19 Vaccine, and rather stressed that it met its most recent vaccine delivery target.

Emergent BioSolutions is an American multinational specialty biopharmaceutical company firm that provides specialty products for civilian and military populations that address intentional and naturally emerging public health threats.

Emergent BioSolutions Incorporated plant in Baltimore, United States

The company also develops vaccines and antibody therapeutics for infectious diseases, opioid overdoses, and provides medical devices for biodefence purposes.

Johnson & Johnson, however, in a statement announced Saturday, April 3, 2021, that it was “assuming full responsibility regarding the manufacturing of drug substance” at the manufacturing plant in Baltimore.

AstraZeneca Plc suspends vaccine production, relocates from Emergent BioSolutions facility in Baltimore

Likewise, ever since The New York Times first reported the incident at the Emergent Vaccine facility Wednesday, March 31, AstraZeneca-Oxford’s Vaccine production at the facility has been suspended.

AstraZeneca Plc in a statement confirmed that it would move production from the plant “in full cooperation with the US Government” and would work with the government “to identify an alternative location for domestic drug substance production.”

It was also learnt that none of the vaccine doses produced and shipped so far in the country have come from that plant, which is not authorised yet, but J&J in an e-mailed statement rather said a batch of drug substance actually failed its quality test.

The vaccine producer’s gaffe would not to change President Biden’s expectation that the country would have enough vaccines for all adults by May this year, according to report.

Subsequently, in a move to facilitate the need to improve on the production hitch involving the 15 million doses, the US Department of Health and Human Services (HHS) worked with AstraZeneca Plc so as to relocate its production out of that plant, so it can focus only on Johnson & Johnson, agency report stated.

In a way to ensure things are properly done going forward, the company stated that it “is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company specialists already at Emergent” Vaccine facility.

As the vaccine schedule is being accelerated in the US, which surpassed 100 million people with at least a dose of a COVID-19 shot Friday, April 2, the J&J error at the plant indicates that there are manufacturing factors that could complicate the rollout in the country, report said.

Status of Emergent BioSolutions Incorporated in the US

More so, the Emergent BioSolutions Incorporated facility in Baltimore is not yet authorised by the US Food and Drug Administration (FDA), and that  none of the doses administered or available in the country so far have come from that plant ─ a fact that Biden administration’s officials were said to have alluded to in downplaying the fallout of the error.

Following the Emergent’s detection of the initial error, the company disclosed April 1, that a single batch of the drug component involved in mix-up during the production process was isolated and disposed of.

The company noted that “discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process.”

According the US administration, J&J will install a new senior management team to take charge of the production and manufacturing at the Baltimore plant.

The drug manufacturing company will have full responsibility of the operations, production and manufacturing at the site, said the official.

Johnson & Johnson to deliver 100 million COVID-19 Vaccine doses to American Government

J&J Saturday, April 3 disclosed that it expects to deliver almost 100 million doses of the COVID-19 vaccine to the US Government by the end of May 2021.

ConsumerConnect gathered that the company, as of now, has produced by far the smallest supply of the US-authorised COVID-19 vaccines.

Pfizer Inc. and Moderna Inc., the two other virus vaccine producers, were reported to have met their first-quarter targets of 120 million doses and 100 million doses respectively.

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

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