F.D.A. Gives Approval for Emergent Vaccine Plant in Baltimore to Reopen
Federal regulators have approved the reopening of a struggling vaccine manufacturing plant in Baltimore that has been closed for more than three months due to contamination issues that have delayed delivery of approximately 170 million doses of vaccine against the coronavirus.
The turnaround came after a two-day inspection at the plant this week by the Food and Drug Administration and weeks of effort by Johnson & Johnson and its subcontractor, Emergent BioSolutions, to bring the site up to standard.
The FDA halted production at the plant after the discovery at the end of March that workers had accidentally contaminated a batch of Johnson & Johnson vaccine with a key ingredient used in that of AstraZeneca, then manufactured at the same site. The federal government also stripped Emergent of responsibility for manufacturing AstraZeneca’s vaccine and asked Johnson & Johnson to exercise greater control over Emergent’s operations.
“The American people should have high expectations of the partners their government chooses to help them prepare for disaster, and we have even higher expectations of ourselves,” Robert Kramer, CEO of Emerging, said Thursday. .
“We have not delivered on these lofty ambitions in recent months, but resuming manufacturing is a key step, and we are grateful for the opportunity to help end this global pandemic,” he said. -he adds.
The development, reported earlier by the Wall Street Journal, is good news for Johnson & Johnson. Due to Emerging’s failure to meet manufacturing standards, Johnson & Johnson has fallen behind on its contractual commitments to deliver the vaccine to the US government and Europe.
Pfizer-BioNTech and Moderna, the two other developers whose vaccines have been cleared for emergency distribution by US authorities, have supplied most of the vaccines distributed in the United States. The federal government has more than enough doses of these vaccines to meet the country’s needs. It’s unclear whether he will also try to roll out more doses of Johnson & Johnson or export them.
Before shutting down operations, Emergent said the plant had the capacity to produce around one billion doses of vaccine per year. Production will need to be prepared in stages, officials said.
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