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The factory was closed in April after an inspection revealed several violations, including possible contamination of J&J’s vaccines with a key ingredient in AstraZeneca’s Covid vaccine. About 170 million doses of the two vaccines were involved after the inspection, the Times reported.
The FDA confirmed to CNBC that several lots were not “suitable for use”, without confirming the exact number of doses that were thrown away. The agency said it was allowing two batches of vaccine made at the plant to be used, according to an emailed statement. The Associated Press reported that the two batches would represent 10 million doses.
The United States currently has more than enough doses of two other vaccines approved by Pfizer and Moderna to complete immunization of the American population.
The approximately 10 million doses of the Johnson & Johnson vaccine will still be distributed in the United States and given to other countries. The doses recovered will be accompanied by a warning that federal regulators cannot guarantee that the operator of the manufacturing plant, Emergent BioSolutions, followed good manufacturing practices, the Times reported.
“Before making this decision, the FDA conducted a thorough review of the facility records and the results of the quality tests performed by the manufacturer,” the agency said. “Although the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to resolve issues with the management of Janssen and Emerging BioSolutions. . “
The Biden administration planned to give more doses of gunfire, but those plans were stifled by the investigation into the Emergent facility.
The World Health Organization has said 11 billion doses of vaccines are needed globally to help prevent the pandemic from worsening. The United States is buying 500 million doses of two-shot vaccine from Pfizer to distribute to countries in need, President Joe Biden is expected to announce at G-7 meetings this weekend.
– CNBC’s Berkeley Lovelace Jr. contributed to this article.