President Donald Trump's reflection is seen on a screen during a press conference in the Rose Garden of the White House in Washington, Nov. 13, 2020.
Operation Warp Speed — the federal effort to accelerate vaccine development — set as a goal producing 300 million doses this year this year, but fell far short of that, reflecting just how difficult and unpredictable the manufacturing process has been. But it turns out, it’s a lot easier to make thousands of doses for a clinical trial than to churn out millions a month. Making vaccines is a complex, sometimes finicky process, requiring sterile conditions and precise control of temperature and humidity.
Moderna, a small Massachusetts company that has never brought a vaccine to market, has been careful in its estimates, predicting since the summer that it would have “tens of millions” of doses by the end of the year, with two doses required for each person to be fully immunized. Moderna has received more than $2 billion from the federal government to develop and manufacture 100 million doses, and the company has said it can supply about 20 million doses before January.
A Pfizer spokeswoman, Amy Rose, acknowledged that the company was falling short of its initial goals, partly because it had to order new equipment and obtain raw materials for the vaccine. In addition, when Pfizer expanded its trial to 44,000 from 30,000 people this fall, the push to make enough vaccine for thousands more volunteers diverted its attention from scaling up commercial production.
The company’s chief executive, Pascal Soriot, recently told investors that it would fill the vials once it had a clearer picture of when the vaccine, which requires two doses, could be approved. “As soon as you turn this vaccine into vials, the shelf life starts ticking,” he said. Still, even seasoned manufacturers can experience setbacks. Yadav, the supply chain expert, pointed to a shortage of flu vaccines in 2004, when a major manufacturer announced that 50 million doses, or half of the national supply for the United States, had been contaminated. “Those are risks that we will have to keep in mind,” he said.