No. 1 vaccine question not if, butwhen
The promising news that not just one, but two coronavirus vaccines were more than 90 percent effective in early results has buoyed hopes that an end to the pandemic is in sight.
But even if the vaccines are authorized soon by federal regulators — the companies developing them have said they expect to apply soon — only a sliver of the American public will be able to get one by the end of the year.
The two companies, Pfizer and Moderna, have estimated they will have 45 million doses, or enough to vaccinate 22.5 million Americans, by January.
Industry analysts and company executives are optimistic that hundreds of millions of doses will be made by nextspring. But the companies— backed with billions of dollars in federal money—will have to overcome hurdles they have encountered in the early days of making vaccines.
Moderna’s and Pfizer’s vaccines use new technology that never has been approved for widespread use, and they’re ramping up into the millions for the first time.
Other challenges include promptly securing raw vaccine ingredients and mastering the art of creating consistent, high-quality batches.
“The biology of scaling manufacturing is a very temperamental activity, and there were many, many different attempts over the months until we cracked it,” said Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services.
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.
“If thatwas an aspiration— of 300 million by the end of the year — I would say that was the biggest challenge that we had,” Mango said.
Pfizer said this summer that it expected tomake100 million doses by year’s end, but mow says it can produce only half that goal.
One of the main goals of Operation Warp Speed was to work with drug companies tomanufacture the vaccines even before clinical trials were completed, so that millions of doses would be ready to go if a vaccine was successful — something never before tried at this scale.
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.
At the same time, the global scramble for vaccines is straining supplies of everything from stainless steel tanks to the custom-made plastic bags that line them.
Adding to the difficulty, Pfizer and Moderna are using a technology, involving genetic material known as messenger RNA, that allows scientists to quickly adapt the technique for new pathogens. But it never has been commercially manufactured.
“Manufacturing a biological product is a science and an art in some ways,” said Prashant Yadav, who studies health care supply chains at the Center for Global Development in Washington.
Moderna, a small Massachusetts company that never has brought a vaccine to market, has been careful in its estimates. It has predicted since the summer that itwould have “tens of millions” of doses by the end of theyear, 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 100million doses, and the company has said it can supply about 20 million doses before January.
Unlike most of its competitors, Pfizer didn’ t accept federal money to ramp up its manufacturing, instead agreeing to sell the government 100 million doses for $1.95 billion. It has made similar advance agreements with Britain, Canada and Japan, among others.
Dr. Albert B our la, Pfizer’ s chief executive, has said the company can produce up to 50 million doses by the end of the year, and half of that supply will go to other countries. Because the vaccine requires two doses, there will initially be enough for only 12.5 million of 330 million Americans.
AstraZeneca said it had made enough of its vaccine to meet its promise of hundreds of millions of doses by January, but a six-week pause in its trial meant it probably wouldn’t get data on the vaccine’s performance in time to win federal authorization for its use this year.