Johnson & Johnson’s Covid-19 vaccine supplier Catalent had to resort to checking vials by hand for two weeks, one of the production problems that have contributed to the US government being set to receive millions fewer doses than it expected this month.
Catalent, which also fills vaccine vials for Moderna, suffered a setback in the US when tuning up its automated visual verification line, which makes checks on vials, according to people familiar with the matter.
J&J is likely to get US emergency approval for its single shot in the coming days, after advisers to the Food and Drug Administration voted unanimously to endorse it. The company has said it will deliver 4m doses immediately, fewer than the 10m the US government originally expected.
Catalent, a New Jersey-based contract manufacturer, moved staff from other parts of the company to complete the vital checks manually. Mike Riley, president of Catalent Biologics, North America, said it was on track to meet its vaccine production commitments to all customers, including Moderna and Johnson & Johnson.
“Short term variations are normal when initiating new production processes to rapidly increase the supply of safe, high-quality vaccines,” he said. “We are moving as quickly as possible, and we will not make any compromises on safety.”
Other manufacturing problems may have also delayed production. J&J had to scale up its vaccine substance manufacturing from a small facility to a large one in the Netherlands, and another large factory in the US, run by contract manufacturer Emergent Biosolutions. This technology transfer, while far faster than usual, took longer than hoped for, according to a different person familiar with the matter.
A spokesperson for J&J said that it had been “working around the clock” to expand manufacturing across the world. It said it was confident it would meet its targets for the US, of 100m by June 2021, and the EU, which has ordered 200m doses in 2021.
He noted it was adding capacity to fill vials with its recent agreement with Sanofi Pasteur.
“To accelerate production and expand capacity, we have entered into agreements with established manufacturers,” he said. “As all of these sites come online, our supply is expected to increase throughout the year.”
Earlier this week, Jeff Zients, the White House coronavirus co-ordinator, said the initial increase in J&J’s production was slower than it would have liked.
“When we got here five weeks ago we learned that J&J was behind on manufacturing, and our team has been working with them since. And, yeah, I think they’re in a better place now,” he said.
Additional reporting by Kiran Stacey in Washington