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The FDA approves two batches of Johnson & Johnson Covid-19 vaccine doses from the Baltimore facility



(CNN) The U.S. Food and Drug Administration announced Friday that it approved the use of two batches of Johnson & Johnson Covid-19 vaccines produced at the troubled Emergent BioSolutions facility in Baltimore.

This is a significant development as not a single usable dose of the Johnson & Johnson Covid-19 vaccine from this facility has yet been approved.

“Prior to this decision, the FDA conducted a thorough review of plant records and the results of quality tests performed by the manufacturer. Based on this review and given the current COVID-1

9 public health emergency, the FDA concluded that these batches are suitable for use,” the FDA said in a statement. declaration.

CNN reached out to Johnson & Johnson, and the company declined to comment.

The agency said it determined that several other batches of the vaccine from the plant were not suitable for use, and said additional batches are still under review. It added that it was not yet ready to fully clear the plant as an authorized production plant and that it continued to “work through issues there with Janssen and Emergent BioSolutions management.” Janssen is a pharmaceutical company based in Belgium and owned by Johnson & Johnson.

The FDA said it also revised the Johnson & Johnson vaccine approval letter to help facilitate potential exports to other countries.

“These actions followed a comprehensive review of records, including the plant’s production history and the tests performed to evaluate product quality,” said Peter Marks, director of the FDA’s Center for Biology Evaluation and Research, in a statement.

Mark continued, “This review has taken place as Emergent BioSolutions prepares to resume production operations with corrective action to ensure compliance with the FDA’s current requirements for good manufacturing practice.”

CNN previously reported that the FDA was preparing to clear about 10 million doses.

In March, Johnson & Johnson said the plant’s quality control process identified a batch of drug that did not meet quality standards. The statement followed a New York Times report that said as many as 15 million potential doses of vaccines had been destroyed, delaying FDA approval of the Baltimore plant. An FDA inspection report released in April detailed numerous concerns at the facility, including that Emergent had not thoroughly investigated cross-contamination of a viral vaccine drug batch, and there was no thorough review of how people moved in and around the facility as a potential source of pollution.

No shipments of Johnson & Johnson’s coronavirus vaccine have been issued by the federal government for several weeks because the vaccine is in short supply, CNN reported. The lack of shipments is directly related to the problems associated with the Baltimore facility.

The delay in shipments comes as the vaccination rate in the US has slowed in recent weeks.

In five states – Alabama, Louisiana, Mississippi, Tennessee and Wyoming – less than half of adult residents have received a dose of Covid-19 vaccine, according to data released Thursday by the U.S. Centers for Disease Control and Prevention.

In the United States in general, 64% of adults have received at least one dose of Covid-19 vaccine, and approx. 53% are fully vaccinated. The president has set a target of 70% of American adults receiving at least one Covid vaccine shot before July 4, but the United States may not reach that target at this current rate.

Johnson & Johnson said this week that the FDA had approved an extension of the shelf life of its Covid-19 vaccine. The move increases the refrigerated storage time for the vaccine from three months to four and a half months and comes, as some states had said, that currently available doses were set to expire in late June, potentially before they were used.

This story has been updated with more information.


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