FDA to authorize two batches of Johnson & Johnson COVID vaccine made at troubled Baltimore plant; others likely to be tossed

Federal regulators at the U.S. Food and Drug Administration will authorize the use of millions of doses of Johnson & Johnson’s COVID-19 vaccine manufactured at the troubled Baltimore facility temporarily shut down earlier this year due to critical production errors.

About 10 million doses have been OK’d for use under the FDA’s emergency use authorization, a source familiar with the decision said. The source could not say how quickly those doses would be shipped out from Emergent BioSolutions’ Baltimore plant. The person also said federal regulators have recommended that more doses produced at the facility be thrown out, but could not immediately say how many.

The New York Times reported Friday that 60 million doses would need to be destroyed due to potential contamination.

“It’s obviously very tragic that an additional 60 million will have to be discarded at this plant, at this time of a huge global shortage of vaccines,” said Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health.

But that number is nowhere near sufficient to meet global demand. Neither is the 500 million doses of Pfizer-BioNTech vaccine that the administration of Democratic U.S. President Joe Biden pledged to donate overseas. Worldwide need is estimated to be about 11 billion doses, Moss said.

Production at the Emergent BioSolutions plant near Johns Hopkins Bayview Hospital was shut down in April due to mix-up of ingredients for the Johnson & Johnson vaccine. The FDA put Johnson & Johnson in charge of the plant and launched a review of the facility, which was largely paid for by the federal government to handle such needs.

Johnson & Johnson confirmed the authorization of the two batches Friday afternoon, saying the decision would allow the company to continue its efforts to mitigate the coronavirus pandemic.

“Since establishing our COVID-19 vaccine program, Johnson & Johnson has committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere,” said Kathy Wengel, the company’s executive vice president and chief global supply chain officer, in a statement. “Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale, and we appreciate the close collaboration with the FDA and global health authorities.”

The company’s statement said officials would continue to expand global vaccine manufacturing.

Emergent BioSolutions spokesman Matt Hartwig didn’t say when production would resume at the Baltimore facility.

“We are pleased that these initial doses of the Johnson & Johnson COVID-19 vaccine will now be available to protect millions of people from this deadly disease,” he said in a statement. “We look forward to continuing to work with the FDA and Johnson & Johnson toward the release additional doses and resuming production at our Bayview facility.”

Shares of Emergent BioSolutions stock dropped 3% Friday to close at $63.51 each.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency’s moves at Emergent BioSolutions’ bulk vaccine production facility followed an extensive review that included the “production history of the facility and the testing performed to evaluate the quality of the product.”

“This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements,” Marks said.

Inspection reports of the facility made public in April show a range of problems at the Baltimore plant, including cleaning and sterilization failures; lack of adherence to protocols; and potential cross-contamination in multiple areas.

Johnson & Johnson subsequently assumed control of the plant at the request of federal officials.

Friday’s announcement by the FDA also included a decision to extend the shelf life for the refrigerated Johnson & Johnson vaccine to 41/2 months instead of three months, which could expand opportunities for its distribution in the United States and elsewhere.

Moss said the inability to use many of the doses already made at Emergent’s Bayview plant underscores the tension between scaling up production of a lifesaving biologic product and adhering to best scientific methods and practices.

He said the 10 million Johnson & Johnson doses authorized for use are likely to stay in the United States. But now that demand is under 1 million doses a day and there is an ample supply of the Pfizer-BioNTech and Moderna vaccines, they aren’t especially needed domestically.

However, J&J’s single-dose, refrigeration-only vaccine has advantages for those living in remote areas or those who have challenges in returning for a second dose, Moss said.

The shortage likely will affect only a small number of people in the United States, agreed Ravi Srinivasan, associate professor of operations management at Loyola University Maryland’s Sellinger School of Business. Internationally, however, vaccination delays still could have effects on Americans.

“According to CDC statistics, J&J vaccines are only about 6% of the overall doses delivered in the U.S.,” he said. “The production and distribution delays may not be as significant for the U.S., except for folks specifically looking for the single-dose vaccine. However, it may delay vaccinations outside of the U.S. which means international travel may be affected due to these delays.”

For now, there is little Johnson & Johnson available around the country.

Some providers, including Health Care for the Homeless in Baltimore, switched to other vaccines when federal regulators temporarily paused use of the Johnson & Johnson vaccine to investigate a rare blood clotting condition, sowing further doubt among the public about its use.

A federal database shows that no doses of Johnson & Johnson’s vaccine have shipped since early May.

Kevin Lindamood, president and CEO of the homeless services organization, said weeks ago after federal officials largely stopped shipping Johnson & Johnson vaccine that officials were able to provide small numbers of doses left in the pipeline. But the group largely switched to Moderna at its main facility in Baltimore and at sites in the community.

He said the group has built relationships with clients over the years and is able to reach enough people to keep its program going despite logistical challenges. It provides about 300 vaccinations a week.

“Obviously, one and done is easier,” he said. “Some people had suggested we should wait until the single-dose vaccine was back because it’s ostensibly better for our patient population. But no, the best vaccine is the vaccine that is available.”