US tells AstraZeneca to cut ties with manufacturer after mix-up ruined factory’s vaccine batch

US health officials have told AstraZeneca to cut ties with its manufacturing partner amid fears that any more production mishaps could erode the public’s faith in vaccines.

AstraZeneca’s operations at a plant in Baltimore have been halted and will be moved elsewhere after an error by staff from Emergent BioSolutions meant that ingredients were mistakenly mixed into 15 million Johnson & Johnson vaccines which were also being produced at the site.

Those vaccines have had to be destroyed and the delivery of more than 20 million Johnson & Johnson doses is hanging in the balance while quality control issues are addressed.

The pharmaceutical giant has drafted in extra staff and assumed full responsibility for the production of the one-shot jab.

Now, it has been reported that the US Government is helping AstraZeneca find new partners as it seeks to obtain approval from the US Food and Drug Administration.

Emergent Biosolutions, where a mishap spoiled 15 million doses of Johnson & Johnson's COVID vaccine, in Baltimore, Maryland

Emergent Biosolutions, where a mishap spoiled 15 million doses of Johnson & Johnson’s COVID vaccine, in Baltimore, Maryland

Credit: JIM LO SCALZO/EPA-EFE/Shutterstock 

Two have already been identified, according to an insider who spoke to Politico, and the US Government is desperate to avoid any more mistakes so that public confidence in the programme stays strong.

Production of the vaccine has started in anticipation of a green light, with 90 million doses understood to be ready, but having to switch manufacturing sites could prove to have a knock-on effect which slows production down.

While the company was using Emergent BioSolutions for US jabs, it used a different company called Catalent to produce vaccines for Europe, Japan and the international purchasing consortium, COVAX, Politico reported.

It’s unclear if the Catalent plant could take on the added work or if doing so would affect the amount of vaccines sent abroad. Catalent has been contacted for comment.

In a statement on Sunday, Emergent BioSolutions admitted it was winding down its operations with AstraZeneca.

“Emergent expects to align with the U.S. government and AstraZeneca on a mutually agreed ramp down of manufacturing for AstraZeneca’s COVID-19 vaccine bulk drug substance,” it said.

In another statement, AstraZeneca said that it would continue to work closely together with the US Government “to support agreed-upon plans for the development, production and full delivery of the vaccine.”

The Anglo-Swedish company has come under pressure in recent weeks after a number of European countries paused use of the vaccine amid safety concerns related to blood clots.

Now, in another blow to the company, Dr Anthony Fauci, America’s top infectious diseases expert, has voiced doubts that the United States would even need the AstraZeneca vaccine given the contracts which have already been signed with other manufacturers.

“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,” he said last week.

“If you look at the numbers [of doses] that we’re going to be getting … it is likely that we can handle any boost that we need, but I can’t say definitely for sure,” he told Reuters.

On Monday, Dr Fauci said that the US was unlikely to have a vaccine passport scheme, telling the Politico Dispatch podcast: “I doubt that the federal government will be the main mover of a vaccine passport concept.”

The European Medicines Agency has said the AstraZeneca vaccine is “safe and effective” with the benefits outweighing the risks, though seven people in the UK have died from rare blood clots after having the jab.

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