In the midst of a New York Times article about the Novavax COVID vaccine, this familiar comment (emphasis mine):
But the company struggled last fall to begin the U.S. trial by its earlier goal of October. Novavax has placed a big gamble on manufacturing, setting up plants around the world. But making these vaccines is a finicky and unpredictable process even for seasoned drug makers, and Novavax had trouble scaling up beyond the smaller batches needed for early trials.
“Things happen — small things happen,” said Stanley C. Erck, Novavax’s president and chief executive. “And so small things happen, and you lose weeks.”
Before the vaccine is authorized by the Food and Drug Administration, the company will have to show that it can consistently mass-produce the shots to the same quality as those used in its clinical trials, a high bar.
Mr. Erck said that the company is now on track to produce the 2 billion doses it has promised annually, which he acknowledged was an ambitious goal. “Some would say we’re crazy — I won’t say that, though we’re doing something that’s unprecedented,” he said.
Scale-up is hard, especially under pressure. Best wishes to the Novavax scientists, and to all of us.