Covid-19 Vaccine Manufacturing in U.S. Races Ahead


a person standing in front of a refrigerator
 Ashraf Khalil 

Covid-19 vaccine manufacturers are ramping up production, churning out far more doses a week than earlier in the year, progress that is accelerating mass vaccination campaigns in the U.S.

After a slow start, Pfizer Inc., its partner BioNTech SE and Moderna Inc. have raised output by gaining experience, scaling up production lines and taking other steps like making certain raw materials on their own.

Pfizer figured out how to stretch scarce supplies of special filters needed for the vaccine production process by recycling them. Moderna shortened the time it needed to inspect and package newly manufactured vials of its vaccine.

The companies—along with Johnson & Johnson, which recently launched a Covid-19 vaccine—also are teaming up with other firms to further increase production.

In addition, the U.S. government has helped vaccine makers access supplies under the Defense Production Act, suppliers and government officials say. The Biden administration this month said it used the act to provide $105 million in funding to help Merck & Co. make doses of J&J’s Covid-19 vaccine and to expedite materials used in its production.

The improvements and addition of J&J’s shot promises to boost supplies in the U.S. as health authorities accelerate efforts to inoculate enough people to lift restrictions and reopen schools, businesses and other establishments.

The U.S. monthly output for the three authorized vaccines is expected to reach 132 million doses for March, nearly triple the 48 million in February, according to estimates by analysts at Evercore ISI.

“We really should expect over the course of the next month or so a very substantial increase in supply” in the U.S., said Eric Toner, senior scholar with the Johns Hopkins Center for Health Security. Early bottlenecks sourcing materials “have been fixed.”

The global supply of Covid-19 vaccines also is increasing, though access to supplies and the pace of vaccinations vary widely by country. Companies including AstraZeneca PLC and the Serum Institute of India expect to have produced billions of doses of Covid-19 vaccines by the end of this year.

Vaccines are crucial, health experts say, in protecting people against severe cases of Covid-19 and moving past the pandemic and all its restrictions.

In December, Pfizer-BioNTech and Moderna vaccines were cleared in the U.S. Yet initial supplies were limited and the rollout started haltingly. States restricted doses to certain groups, such as the elderly, healthcare workers and people with high-risk medical conditions.

Both the production and administration of shots have picked up in recent weeks, however. Now, some 2.5 million people in the U.S. are vaccinated daily on average, up from about 500,000 in early January, though many who want a vaccine still can’t get it.

The increased output should be enough to fully vaccinate 76 million people in the U.S. in March, another 75 million in April and then 89 million more in May, according to estimates from Evercore ISI analysts. The Pfizer-BioNTech and Moderna vaccines require two doses.

By midsummer, 75% of Americans 12 years old and above should be vaccinated, according to Morgan Stanley. The vaccines aren’t currently authorized for anyone younger than 16, but companies may have results this spring for studies of the shots in adolescents 12 and older, which, if positive, could lead to vaccinations for that age group. The companies are also starting to test the vaccines in children younger than 12, but results of those studies aren’t expected until late this year.

With production ramping up, President Biden said March 11 that he wants states to widen eligibility to all adults by May 1 and has said the U.S. should have enough supply for all adults by the end of May.

Moderna, of Cambridge, Mass., took about three months to make the first 20 million doses of its vaccine last year, but now it is making roughly 40 million a month for the U.S., Juan Andres, chief technical operations and quality officer, said in an interview.

He said the company would likely peak at producing 50 million a month by summer.

Moderna laid much of the groundwork for its production capacity last year by adding floor space and new equipment to its plant in Norwood, Mass., and another plant in Portsmouth, N.H., operated by its contract manufacturing partner Lonza Ltd.

It wasn’t able to produce at maximum capacity right out of the gate, however, because of the need to introduce new equipment and processes in stages. Moderna was still training newly hired workers and encountering issues like equipment malfunctions and holdups in getting replacement parts such as filters.

“There has not been a single week since we started that we have not had issues,” Mr. Andres said. “In making medicines, it is absolutely impossible not to have issues in the beginning. It takes time.”

Now, the company has trained employees and figured out how to address challenges like getting raw material to its plants more quickly, he said. The company has also looked for ways to speed the process, including shortening the time needed after a batch is finished to inspect and package vials.

It is planning to further speed output by boosting the number of doses in each vial to 15 from 10, something that needs U.S. regulatory approval, Mr. Andres said.

“We’re in the zone,” he said. “I like our chances to continue delivering.”

New York-based Pfizer has more than doubled its weekly U.S. output of Covid-19 vaccine doses to more than 13 million, from five million at the beginning of February, according to a Pfizer spokeswoman.

Pfizer increased output partly by figuring out that it was going through supplies of certain circular filters used in the production process quickly and couldn’t get more from its supplier as fast as it needed. The filters remove certain components from the vaccine during production.

The company began recycling the filters so that it could reuse each one two or three times, said Chaz Calitri, Pfizer’s vice president of operations for sterile injectables for the U.S. and Europe.

The company also was facing constraints in obtaining from external suppliers the tiny fat particles known as lipids that form the protective shell around the genetic material in the vaccine. So Pfizer began producing the material at its plants in Kalamazoo, Mich., and Groton, Conn., and has completed three batches, Mr. Calitri said.

And the company added more high-speed vial-filling lines to its Kalamazoo plant and will expand vial filling to another plant in McPherson, Kan. The lines can fill up to 575 vials a minute, Mr. Calitri said.

“We’re not done by any means,” he said. “There’s no doubt we’ll blow through 13 million a week and go much higher in the very near future.”

Johnson & Johnson’s initial supply, when the company’s vaccine was authorized late last month, was lower than what federal officials expected, but analysts expect a steadier output to kick in within weeks that will add to the overall supply of doses.

J&J is boosting in-house production and is working with other companies including Merck to expand further. A J&J spokesman said the company was on track to deliver a total of 20 million doses for use in the U.S. by the end of March.

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