![]() 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: 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. 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. The US has said it plans to share 60 million doses of AstraZeneca's vaccine with other countries in need. Until the FDA tests those doses to confirm quality, the doses cannot be distributed. 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 Emergent fixes the problems identified by the FDA, the agency won’t allow the company to produce or distribute the vaccine. Vaccine production at the facility remains on pause. ![]() 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. The FDA on April 16 completely halted production at the facility, citing serious quality control failings and other violations. Emergent was producing both vaccines in the single facility and contaminated batches of each vaccine with elements of the other. But the Emergent facility has been riddled with problems and still has yet to earn FDA authorization to produce vaccines.Īt 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. Meanwhile, the company intended to ramp up US production at a contracted facility in Baltimore run by Emergent BioSolutions. 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. The dried-up supply is just the latest trouble for Johnson & Johnson, which has consistently struggled to produce its vaccine in the US. 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. White House officials told governors in a call Tuesday that there are no new doses available for order. States will not receive shipments of Johnson & Johnson’s one-shot COVID-19 vaccine next week, according to a report by Politico. Getty | Saul Loeb reader comments 110 with
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