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J&J tapped Emergent at the start of the pandemic to help produce millions of doses of its vaccine, but the small contract manufacturer is increasingly under scrutiny by regulators – raising concerns about its capacity to achieve its production goals. Administration officials last month ordered another pharmaceutical giant, AstraZeneca, to leave the Maryland plant after Emergent mixed ingredients for the two vaccines, ruining 15 million doses of J&J.

“Pending full comments from the FDA, we are working with J&J and the FDA on strengthening the supply chain for this vitally important vaccine,” Emergent said in a statement. “We recognize that we need to make improvements to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes.”

The FDA declined to comment on the matter.

It’s unclear how long Emergent’s production hiatus could last. Although the FDA has not given Emergent emergency clearance to take the J&J shot – meaning none of the photos produced at the company’s plant have yet been returned public – the facility was set to play a significant role in J&J production and hit the 100 million dose pledge by June.

But production issues aren’t the only obstacle for the J&J vaccine. Nearly 7 million Americans received the single-dose vaccine before federal regulators last Tuesday advised providers across the country to suspend use due to rare but serious blood clots. The hiatus could last for weeks, questioning how many doses of J&J could be used this summer.

The pharmaceutical company also enlisted Merck to help it fill and finish the vials and produce the vaccine. But the facility Merck intends to use for vaccine ingredients in North Carolina is not expected to begin manufacturing until the second half of this year.

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