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The FDA authorizes two batches of Johnson & Johnson Covid-19 vaccines from the Baltimore plant



“Before taking this decision, the FDA conducted an in-depth review of the equipment archives and the results of quality tests performed by the manufacturer. Based on this review and in view of the current COVID-19 public health emergency, the FDA concluded that these batches are suitable for use, “the FDA said in a statement.

CNN contacted Johnson & Johnson and the company declined to comment.

The agency said it had found that several other batches of the plant’s vaccine were not suitable for use, and said additional batches were still under review. He added that he was not yet ready to completely clean the facility as an authorized production facility and that he continued to “work on the problems there with the management of Janssen and Emergent BioSolutions”

;. Janssen is a pharmaceutical company based in Belgium and owned by Johnson & Johnson.

The FDA said it had also reviewed the Johnson & Johnson vaccination authorization letter to facilitate potential exports to other countries.

“These actions were followed by an extensive review of the records, including the facility’s production history and tests performed to assess product quality,” said Peter Marx, director of the FDA’s Center for Evaluation and Research of Organic Products.

Marx continues: “This review is underway as Emergent BioSolutions prepares to resume manufacturing operations with corrective action to ensure compliance with current FDA 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 had identified a batch of a drug that did not meet quality standards. The statement followed a report in the New York Times that said 15 million potential doses of vaccines had been destroyed, delaying the FDA’s approval of the Baltimore plant. The FDA inspection report, released in April, clarified numerous concerns at the facility, including that Emergent did not thoroughly investigate cross-contamination of a batch of viral vaccine and did not conduct an in-depth review of how people moved in and around the site. potential source of pollution.

No shipment of Johnson & Johnson’s coronavirus vaccine has left the federal government in a few weeks because the vaccine is in short supply, CNN reported. The lack of shipments is directly related to problems with the Baltimore plant.

The supply lag is coming as the pace of vaccination in the US has slowed in recent weeks.

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

Overall in the United States, 64% of adults have received at least one dose of Covid-19 vaccine and about 53% have been fully vaccinated. The president has set a goal for 70% of adults in the United States to receive at least one vaccine against Covid by July 4, but the United States may not achieve this goal at current rates.

Johnson & Johnson said this week that the FDA has approved an extension of its Covid-19 vaccine. This move increases the refrigerated storage time of the vaccine from three months to four and a half months, and comes as some states have said that the available doses should expire in late June, probably before they can be used.

This story has been updated with additional information.


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