Skip to content
FDA clears two batches of Johnson & Johnson Covid-19 vaccine doses from Baltimore plant

“Prior to making this decision, the FDA conducted a thorough review of the facility’s records and the results of the quality tests performed by the manufacturer. Based on this review and in light of the COVID public health emergency At the current time, the FDA has concluded that these lots are suitable for use, ”the FDA said in a statement.

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

The agency said it had determined that several other batches of the plant’s vaccine were unsuitable for use, and said additional batches are still under review. He added that he was not yet ready to authorize the installation of the facility as an authorized manufacturing facility and that he continued to “resolve issues with Janssen and the management of Emerging BioSolutions.” Janssen is a pharmaceutical company based in Belgium and owned by Johnson & Johnson.

The FDA said it also revised the Johnson & Johnson vaccine authorization letter to facilitate potential export to other countries.

“These actions follow a thorough review of the records, including the production history of the facility and the tests performed to assess product quality,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA in a statement.

Marks continued, “This review took place as Emerging BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with current FDA Good Manufacturing Practices.”

CNN previously reported that the FDA was preparing to authorize around 10 million doses.

In March, Johnson & Johnson said the plant’s quality control process identified a batch of drug substance that did not meet quality standards. The statement follows a New York Times report that as many as 15 million potential doses of vaccine had been destroyed, delaying FDA clearance for the Baltimore plant. An FDA inspection report released in April detailed many concerns at the facility, including the fact that Emerg had not thoroughly investigated the cross-contamination of a batch of viral vaccine drug substance, and there had not been a thorough examination of how people moved in and around the facility as a potential source of contamination.

No delivery of the Johnson & Johnson coronavirus vaccine has been released from the federal government for several weeks because the vaccine is insufficient, CNN reported. The lack of shipments is directly related to the problems with the Baltimore plant.

The delay in shipments comes as the pace of vaccination in the United States 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 the Covid-19 vaccine, according to data released Thursday by the U.S. Centers for Disease Control and Prevention.

In the United States as a whole, 64% of adults have received at least one dose of the Covid-19 vaccine and about 53% are fully vaccinated. The president has set a target of 70% of American adults receiving at least one Covid vaccine by July 4, but the United States may not meet that target at the current rate.

Johnson & Johnson said this week that the FDA has authorized an extension of the shelf life of its Covid-19 vaccine. The move increases the vaccine’s refrigerated storage time from three months to four and a half months, and comes as some states have said currently available doses must expire in late June, potentially before they can be used.

This story has been updated with additional information.

.



Source link