Vaccine Makers Set to Tell Congress Supply Strains Ebbing

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Feb 23 2021, 2:15 AMFeb 23 2021, 3:57 AMFebruary 23 2021, 2:15 AMFebruary 23 2021, 3:57 AM

(Bloomberg) -- Vaccine makers indicated that some of the big bottlenecks that have shadowed the U.S. immunization campaign could soon begin to ease, in testimony submitted for a Capitol Hill hearing Tuesday.

Moderna Inc. said it has received positive feedback from U.S. regulators on a proposal to expand the number of doses of its Covid-19 vaccine in each vial, while Pfizer Inc. said it expects its output to ramp up in coming weeks. And Johnson & Johnson, which could gain clearance for its one-shot vaccine as soon as this week, said it will be ready to ship millions of doses.

In prepared testimony for a Congressional hearing on Tuesday, Moderna said the U.S. Food and Drug Administration could allow it to put as many as 15 doses of its Covid-19 shot into each vial. Currently, its vials hold 10 doses. If authorized, the change could quickly increase supply of this vaccine, as one of the main production bottlenecks for Moderna has been at vial-filling plants.

Meanwhile, Pfizer said improvements and expansions to its vaccine manufacturing effort could allow it to ship 13 million doses of its vaccine a week by mid-March, up from 4 million to 5 million doses a week in early February.

In its statement, J&J said it may be able to produce enough of its one-dose vaccine to inoculate more than 20 million Americans by the end of March. Having a single-dose shot could help many Americans get fully vaccinated more quickly, as the currently authorized vaccines each require two doses for complete protection. The FDA is reviewing J&J’s shot.

The House Energy and Commerce Committee is scheduled to hold a hearing of Covid-19 vaccine manufacturers to discuss expanding the availability of shots.

Johnson & Johnson is planning to begin shipping immediately after receiving an emergency-use authorization. The vaccine is being reviewed on February 26 by a panel of independent FDA advisers and if panel vote is favorable as expected, emergency clearance could come soon after.

Discussions between Moderna and the U.S. government about increasing the number of doses per vial began with the Trump administration’s Operation Warp Speed program, according to its former Chief Scientific Adviser Moncef Slaoui.

Dosing Shifts

By making each vial more efficient, Slaoui said, Moderna will be able to circumvent some of the difficulties faced in the last stage of the production process, known as fill-finish, where the vaccine’s substance is placed in vials, packaged and distributed.

Pfizer, which produces a similar vaccine to Moderna’s, has received a green light from regulators to extract an additional dose from each of its vials. As a result, the company has increased its expected output for the year by 50%.

Pfizer said in testimony prepared for the hearing that it expects to produce 13 million vaccine doses a week by the middle of March, more than previous projections. Chief business officer John Young said that by the end of July, it should be able to ship all 300 million doses it is contracted to provide in the U.S. -- enough to vaccinate 150 million people.

Vaccine makers at the hearing are expected to discuss other ways to increase supply, such as by reaching agreements with contract manufacturers and creating partnerships across the industry to secure additional capacity.

With the exception of Pfizer, all of the companies that will be present received funding from Operation Warp Speed to accelerate vaccine development and manufacturing as well as to secure supply. Pfizer and German partner BioNTech SE rejected U.S. capital for research and manufacturing, while still reaching supply agreements with the government.

To date, U.S. regulators have only authorized the Moderna and Pfizer-BioNTech shots, both of which require two-dose regimens. A total of 63.1 million doses have been administered, according to Bloomberg’s vaccine tracker, and more Americans have now received at least one dose than have tested positive for the virus since the pandemic began.

However, as second doses are coming due, state health systems have been strained for supply, leaving some without complete immunizations.

The Trump and Biden administrations have employed a Cold War-era law known as the Defense Production Act to help secure materials to accelerate production of the Pfizer-BioNTech shot, among others. On Friday, Pfizer CEO Albert Bourla announced the company was on-boarding new production facilities and suppliers of the vaccine.