FDA authorizes two batches of Johnson & Johnson COVID-19 vaccine doses from Baltimore plant

“Before making this decision, FDA conducted a thorough review of the facility records and the results of quality testing conducted by the manufacturer. Based on this review and given the current COVID-19 public health emergency, FDA concluded that these batch use are suitable for.” The FDA said in a statement.

Kathy Wengel, executive vice president and chief global supply chain officer at Johnson & Johnson, lauded the progress on Friday.

“Today’s decisions represent progress in our continued efforts to address this pandemic on a global scale, and we appreciate the close cooperation we have with the FDA and global health officials,” Wengel said in a statement. “The company continues to expand our global vaccine manufacturing network as we work with regulatory and health authorities to supply our COVID-19 vaccine around the world.”

The FDA said it had determined that several other batches of the vaccine from the plant were not suitable for use and added that additional batches were still being reviewed.

An official said five batches were rejected after a quality review was carried out, an estimated 60 million doses.

The FDA said it was not yet ready to fully clear the facility as an authorized manufacturing facility and that it was continuing to “work through issues with Janssen and Emergent BioSolutions’ management.” Janssen is a pharmaceutical company based in Belgium and owned by Johnson & Johnson.

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

“These actions warrant a comprehensive review of the record, including the facility’s production history and tests conducted to evaluate product quality,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Marks continued: “This review is taking place as Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current Good Manufacturing Practice requirements.”

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

In March, Johnson & Johnson said that the quality control process at the plant identified a batch of pharmaceutical substances that Did not meet quality standards. The statement followed a New York Times report that said 15 million potential doses of vaccines were wasted, delaying FDA authorization of the Baltimore plant. An FDA inspection report released in April detailed a number of concerns at the facility, including that Emergent had not thoroughly investigated cross-contamination of the viral vaccine drug substance batch, and that it did not fully review whether people were infected with this drug. How to get in and around the facility. Possible source of contamination.

CNN has reported that no shipments of Johnson & Johnson’s coronavirus vaccine have flown from the federal government in several weeks because the vaccine is in short supply. The lack of shipments is directly linked to issues related to the plant in Baltimore.

The lag in shipments comes as vaccinations in the US have slowed in recent weeks.

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

Overall in the US, 64% of adults have received at least one dose of the COVID-19 vaccine and about 53% have been fully vaccinated. The president has set a target of 70% of American adults getting at least one COVID vaccine shot by July 4, but the US may not reach that target at the current pace.

Johnson & Johnson said this week that the FDA had authorized an extension of the shelf life of its COVID-19 vaccine. The move extends the refrigerated storage time for the vaccine from three months to four-and-a-half months, and some states had said the currently available dose was scheduled to expire at the end of June, possibly before being used.

This story has been updated with additional information.

.



Source link

Popular Topics

Related Articles