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J&J vaccine supply has run out; Emergent says it’s working on improvements

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.
Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

States will not receive shipments of Johnson & Johnson’s one-shot COVID-19 vaccine next week, according to a report by Politico.

White House officials told governors in a call Tuesday that there are no new doses available for order. It’s unclear if the federal government will be able to distribute doses through other channels, such as those that provide vaccines directly to pharmacies and community health centers.

The dried-up supply is just the latest trouble for Johnson & Johnson, which has consistently struggled to produce its vaccine in the US.

Since the vaccine earned authorization from the Food and Drug Administration on February 27, Johnson & Johnson has shipped doses produced in the Netherlands into the US. Meanwhile, the company intended to ramp up US production at a contracted facility in Baltimore run by Emergent BioSolutions. But the Emergent facility has been riddled with problems and still has yet to earn FDA authorization to produce vaccines.

At the end of March, news leaked that Emergent had spoiled 15 million doses of Johnson & Johnson’s vaccine and millions more doses of AstraZeneca’s vaccine. Emergent was producing both vaccines in the single facility and contaminated batches of each vaccine with elements of the other. The FDA on April 16 completely halted production at the facility, citing serious quality control failings and other violations. Federal lawmakers have since opened an investigation into whether Emergent used connections in the Trump administration to get billions of dollars’ worth of federal contracts despite a long track record of quality control and reliability problems.

Quality questions

Vaccine production at the facility remains on pause. Until Emergent fixes the problems identified by the FDA, the agency won’t allow the company to produce or distribute the vaccine. Moreover, FDA inspectors found reason to doubt the quality of previously made doses of Johnson & Johnson’s vaccine and stockpiled doses of AstraZeneca’s vaccine. Until the FDA tests those doses to confirm quality, the doses cannot be distributed.

The US has said it plans to share 60 million doses of AstraZeneca’s vaccine with other countries in need. AstraZeneca’s vaccine is used widely worldwide, but it’s not yet authorized for use in the US, and officials have said the vaccine might not be needed here. Though the US has about 10 million doses of the vaccine stockpiled, those doses cannot be shared with other countries yet because of the quality control problems at Emergent.

In an update to media posted Wednesday, Emergent said it has “responded to FDA’s observations with a comprehensive quality enhancement plan.” The statement continued:

We have already started making improvements and we are fully committed to making the necessary short- and long-term enhancements to meet or exceed FDA’s standards. We continue to have constructive, on-going dialogue with the FDA and Johnson & Johnson as we work on the path forward to release drug substance currently under evaluation and to resume production.

The production problems, along with an earlier safety pause, have led Biden administration officials to privately give up on having Johnson & Johnson’s vaccine play a significant role in its national vaccination campaign, according to an earlier report by Politico. Supplies of Moderna and Pfizer-BioNTech vaccines continue to be robust.

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