The US Food and Drug Administration said Friday that Johnson & Johnson must discard millions of doses of its COVID-19 vaccine that were manufactured in a troubled Baltimore factory, but have also authorized millions for use.
Two sources familiar with the situation told Reuters that the agency had authorized about 10 million doses. The New York Times said the discarded batches total about 60 million doses, citing people familiar with the matter.
Without disclosing or confirming the number of vaccine doses, the FDA said in a press release that it had authorized the use of two lots of the vaccine, that several other lots were not suitable for use, and that others were being evaluated.
The agency said it was not yet ready to license the Emergent BioSolutions Inc plant to manufacture the J&J vaccine. US authorities halted J&J vaccine production at the Baltimore site in April and J&J took over manufacturing at the plant.
A source familiar with the matter told Reuters that the doses of J&J are expected to be exported to other countries. The doses are already in vials and ready to use, the other source said.
Safety concerns about the J&J vaccine, along with declining US demand for vaccines overall, have slowed the launch of the single-shot vaccine at an accelerating rate. About half of the 21 million doses produced for the United States remain unused.
The FDA said its decision allows the J&J doses to be used in the United States or exported. The agency said the drug manufacturer and Emergent must agree that the FDA can share relevant information about the manufacture of the doses with the regulators where the vaccine is shipped.
J&J, in a statement, confirmed that the FDA authorized the two batches, but did not recognize the doses that regulators decided should be discarded.
“Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale,” Kathy Wengel, director of global supply chain at J&J, said in the statement.
The FDA declined to comment beyond its statement.
Last month, Emergent CEO Robert Kramer said he understood that there are 100 million doses of the J&J vaccine ready for FDA review and that regulators had begun the review process.
The April stoppage followed the discovery that ingredients in AstraZeneca’s COVID-19 vaccine, which was also produced at the plant at the time, contaminated a batch of J&J vaccine. AstraZeneca shooting is no longer being done there.
An FDA inspection also revealed a long list of sanitary problems and poor manufacturing practices at the Emergent plant.
Separately, the European drug regulator said on Friday that batches of the J&J COVID-19 vaccine made for the region around the time contamination issues were revealed at the Baltimore plant would not be used, as a precaution.
The European Medicines Agency did not say how many injections were affected, but Reuters reported that it involves millions of doses, making it difficult for J&J to meet the target of delivering 55 million to Europe by the end of June.
Later on Friday, Canada’s drug regulator said it would not deliver the shipment of doses of J & J’s COVID-19 vaccine, which were made at the Baltimore plant.
Health Canada said it was planning an on-site inspection this summer and would not accept any products or ingredients made at the plant until the inspection is complete.
(Reporting by Michael Erman in Maplewood, NJ; additional reporting by Mrinalika Roy and Ankru Bannerjee in Bengaluru; edited by Bill Berkrot and Anil D’Silva)