Biden administration stops AstraZeneca vaccine production at plant that ruined 15 MILLION doses of Johnson & Johnson's COVID-19 shot
President Joe Biden's administration has stopped a Baltimore manufacturing plant from making AstraZeneca's COVID-19 vaccine after it ruined 15 million doses of Johnson & Johnson's vaccine.
The Department of Health and Human Services also put Johnson & Johnson in charge of the Emergent BioSolutions plant which will now solely be devoted to the company's single-dose vaccine, The New York Times reported.
Emergent BioSolutions, a contract manufacturer, had been making both the Johnson & Johnson and the AstraZeneca vaccines but alarmingly mixed up ingredients from the two, which led regulators to delay authorization of the plant's production lines.
The move is meant to avoid future mix-ups, according to the report, which cites two senior federal health officials.
Federal officials told the outlet that they are worried the mix-up 'will erode public confidence in Covid-19 vaccines.'
President Joe Biden's administration has stopped a Baltimore manufacturing plant from making AstraZeneca's COVID-19 vaccine
Emergent BioSolutions, a contract manufacturer, had been making both the Johnson & Johnson and the AstraZeneca vaccines
The Biden administration knew more than a week before it became public that Johnson & Johnson's 15million doses of vaccine had been ruined by its contractor
Johnson & Johnson said on Wednesday that a batch of vaccine made by Emergent at its Baltimore factory, known as Bayview, cannot be used because it did not meet quality standards.
The company said in a statement it was still planning to deliver 100 million doses by the end of June and was 'aiming to deliver those doses by the end of May.'
'Human errors do happen,' Dr. Anthony Fauci, the nation´s top infectious disease expert, said Thursday in an interview on CBS' 'This Morning.'
'You have checks and balances. ... That´s the reason why the good news is that it did get picked up. As I mentioned, that´s the reason nothing from that plant has gone into anyone that we´ve administered to.'
It was revealed on Wednesday that Emergent BioSolutions had a string of citations from U.S. health officials for quality control problems.
The little-known company was vital to the vaccine supply chain and was a key to Johnson & Johnson's plan to deliver 100 million doses of its single-shot vaccine to the United States by the end of May.
But the Food and Drug Administration repeatedly cited Emergent since 2017 for problems such as poorly trained employees, cracked vials and problems managing mold and other contamination, according to records obtained by the Associated Press through the Freedom of Information Act.
White House press secretary Jen Psaki said Thursday that none of the J&J vaccine doses on the market are affected and the company was on track to deliver 24 million doses in April and 100 million doses by the end of May.
'These are doses that the U.S. government has purchased, but we also have plenty of doses from Pfizer and Moderna, regardless, Psaki said.'
The Biden administration knew more than a week before it became public that Johnson & Johnson's 15million doses had been ruined by its contractor.
A healthcare worker receives the Moderna Inc. Covid-19 vaccine in Tucson, Arizona
People line up in cars to receive the COVID-19 vaccination at State Farm Stadium on February 11, 2021 in Glendale, Arizona
Two senior officials on the government's Covid-19 response team told Politico that it was clear there were serious problems at the West Baltimore plant of Emergent BioSolutons, a little-known company at the center of the vaccine supply chain.
A third official said the Department of Health then found out last week that Emergent had ruined 15million doses of vaccine by adding the wrong ingredient.
'It was no secret that Emergent did not have a deep bench of pharmaceutical manufacturing experts,' that official told Politico on Wednesday.
Johnson & Johnson locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture the vaccine J&J was developing with federal money.
In February, before the Johnson & Johnson's vaccine received emergency authorization by the FDA, the Biden administration said it was exploring every option for increasing manufacturing of the company's vaccine.
The White House has invoked the Defense Production Act to help Pfizer ramp up COVID-19 vaccine production and that 'every option' was on the table to produce more Johnson & Johnson vaccine.
Emergent Biosolutions' Chief Executive Robert Kramer said in an interview at the time that the company currently was making bulk drug substance for Johnson & Johnson 'at large scale.'
Emergent was only producing bulk vaccine, which is then filled into syringes or vials and packaged for shipment by another contractor.
Kramer said they were on track to make enough product for hundreds of millions of doses a year. It remains unclear what other supply bottlenecks may be.
Kramer said his company had already benefited from the Defense Production Act under the Trump Administration, which helped the company get to the point where it's ready to go.
Under the authority of the Defense Production Act, the government will give priority ratings to two components important to Pfizer´s vaccine production - filling pumps and tangential flow filtration units, the officials said.
Emergent's revenues skyrocketed during the Trump administration, jumping from around $523 million in 2015 to more than $1.5 billion in 2020. The company has invested heavily in lobbying the federal government, according to disclosure records, which show the company spent $3.6 million on lobbying in 2020 alone.
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