Covid-19 vaccine manufacturing in U.S. races ahead

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

The companies, along with Johnson & Johnson,

which recently launched a vaccine against Covid-19, are also partnering with other companies to further increase production.

In addition, the U.S. government has helped vaccine manufacturers access supplies under the Defense Production Act, according to suppliers and government officials. The Biden administration said this month that it used the act to provide $ 105 million in funding to help Merck & Co. to dose the J&J Covid-19 vaccine and to speed up the materials used in its production.

Improvements and the addition of the J&J feature promise to increase supplies in the U.S. as health authorities accelerate efforts to inoculate enough people to lift restrictions and reopen schools, businesses and other establishments.

U.S. monthly production for the three authorized vaccines is projected to reach 132 million doses by March, nearly three times the February 48 million, according to estimates by Evercore ISI analysts.

“We really should expect over the next month or so a substantial increase in supply,” said Eric Toner, a senior academic at the Johns Hopkins Center for Health Security. The first bottlenecks that supplied materials “have been fixed.”

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

According to health experts, vaccines are crucial to protect people from severe cases of Covid-19 and get out of the pandemic and all its restrictions.

In December, the Pfizer-BioNTech and Moderna vaccines in the US were phased out. However, initial supplies were limited and the launch began in parallel. States restricted doses to certain groups, such as the elderly, health care workers, and people with high-risk medical conditions.

However, both production and plan management have increased in recent weeks. Now, an average of 2.5 million people in the U.S. get vaccinated daily, up from 500,000 in early January, although many who want a vaccine still can’t get it.

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

In the middle of summer, 75% of Americans 12 and older should get vaccinated, according to Morgan Stanley. Vaccines are not currently allowed for children under 16, but companies may have results this spring for vaccine studies in teens 12 and older, which, if positive, could lead to vaccinations for this group. of age. Companies are also starting testing vaccines in children under 12, but no results from these studies are expected until later this year.

With the increase in production, President Biden said on March 11 that he wants states to extend eligibility for all adults before May 1 and said the United States should have enough supply for all adults in late May.

Moderna, of Cambridge, Massachusetts, took about three months to make the first 20 million doses of its vaccine last year, but now it makes about 40 million a month for the United States, said Juan Andres, head of ‘technical operations and quality officer. in an interview.

He said the company would likely get to produce 50 million a month in the summer.

Modern laid much of the foundation for its production capacity last year by adding new flooring and equipment to its plant in Norwood, Massachusetts, and another plant in Portsmouth, NH, operated by its contractual manufacturing partner Lonza Ltd. .

However, it was unable to produce at full capacity due to the need to introduce new equipment and staged processes. Modern was still training newly hired workers and was facing problems such as equipment malfunctions and retentions to get spare parts such as filters.

“There hasn’t been a week since we started that we haven’t had any problems,” Andres said. “When medicines are made, at first it is absolutely impossible not to have problems. It takes time. “

Now, the company has trained workers and figured out how to tackle challenges such as getting raw materials to its plants faster, he said. The company has also looked for ways to speed up the process, including shortening the time required after finishing a batch to inspect and package the vials.

He is planning to speed up production by increasing the number of doses on each vial from 15 to 10, which needs approval from U.S. regulation, Andres said.

“We’re in the area,” he said. “I like our chances of continuing to deliver.”

New York-based Pfizer has more than doubled U.S. weekly production of Covid-19 vaccine doses to more than 13 million, from five million in early February, according to a Pfizer spokeswoman.

Pfizer increased production in part by finding out that it quickly went through supplies of certain circular filters used in the production process and that it could not get more from its supplier as quickly as it needed to. Filters remove certain components from the vaccine during production.

The company began recycling the filters so they could be reused each two or three times, said Chaz Calitri, Pfizer’s vice president of sterile injections operations for the United States and Europe.

The company also faced restrictions on obtaining from external suppliers the small fat particles known as lipids that form the protective layer around the vaccine’s genetic material. Thus, Pfizer began producing the material at its plants in Kalamazoo, Michigan, and Groton, Connecticut, and has completed three batches, Calitri said.

And the company added more high-speed road filling lines to its Kalamazoo plant and will expand road filling to another McPherson plant, Kan. Lines can fill up to 575 vials per minute, Calitri said.

“We’re not finished in any way,” he said. “There is no doubt that we will exceed 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 federal officials expected, but analysts expect more stable production to occur in a few weeks that will add up. to the global dose supply.

J&J is driving its own production and working with other companies, including Merck, to expand even 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.

—Jared S. Hopkins contributed to this article

Write to Peter Loftus to [email protected]