Catalent, a Covid-19 vaccine supplier to Johnson & Johnson, had to resort to manual vial checking for two weeks, one of the production issues that helped the U.S. government be ready to receive millions of doses less than expected this month.
Catalent, who also fills the vaccine vials for Moderna, suffered a setback in the United States when adjusting its automated visual check line, which checks vials, according to people familiar with the matter.
J&J is expected to get emergency approval from the United States for its single shot in the coming days, according to Food and Drug Administration advisers. voted unanimously to approve it. The company announced that it would immediately deliver 4 million doses, which is less than the 10 million initially expected by the US government.
Catalent, a New Jersey-based contract manufacturer, has transferred staff from other parts of the business to manually perform vital checks. Mike Riley, president of Catalent Biologics, North America, said he was on track to meet his vaccine production commitments to all of his customers, including Moderna and Johnson & Johnson.
“Short-term variations are normal when starting new production processes to rapidly increase the supply of safe, high-quality vaccines,” he said. “We are acting as quickly as possible and we will not compromise on safety.”
Other manufacturing issues may also have delayed production. J&J had to scale up its manufacturing of vaccine substances from a small facility to a large one in the Netherlands, and another large plant in the United States, managed by contract manufacturer Emergent Biosolutions. This transfer of technology, while much faster than usual, took longer than expected, according to another person familiar with the matter.
A spokesperson for J&J said it had “worked around the clock” to expand manufacturing around the world. He said he was convinced he would meet his targets for the United States of 100 million by June 2021 and the EU, which has ordered 200 million doses in 2021.
He noted that he was adding capacity to fill the vials with his recent agreement with Sanofi Pasteur.
“To speed up production and increase capacity, we have entered into agreements with established manufacturers,” he said. “As all of these sites are online, our offer should increase throughout the year.”
Earlier this week, Jeff Zients, the White House coronavirus coordinator, said the initial increase in J&J production was slower than it would have liked.
“When we got here five weeks ago, we learned that J&J was behind in manufacturing, and our team has been working with them ever since. And, yeah, I think they’re in a better place now, ”he says.
Additional reporting by Kiran Stacey in Washington