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Wednesday, March 3rd, 2021

COVID-19 vaccine makers report vast step-up in capacity

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Five COVID-19 vaccine manufacturers assured Congress Tuesday that they are closely watching the emergence of new variants of COVID-19 and are optimistic the two vaccines currently approved in the United States and a third poised for approval will treat those new variants that have emerged in the U.K. and South Africa, but the representatives from all five companies agreed more research needs to be done on the new strains.

Top executives of Pfizer and Moderna, the only companies approved to distribute a COVID-19 vaccine in the U.S., said they are confident their vaccines protect against the emerging variants but are studying whether a booster of some sort may be necessary to provide adequate protection of the new strains or other emerging variants. “We’ve initiated a study on the benefit of a booster on people who have already received the vaccine,” John Young, group president and chief business officer of Pfizer, told members of the U.S. House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations.

“We are closely monitoring emerging variants and testing the performance of our vaccine against them,” said Dr. Stephen Hoge, president of Moderna. “We are also studying potential booster shots, either of the existing vaccine or of a version that has been adjusted to address significant variants.”

Novavax, according to John Trizzino, chief commercial officer and chief business officer for the company, is already working on a strategy to provide the broadest coverage. “We initiated development of new constructs against the emerging strains in early January of this year and are already testing them in preclinical animal models. A hallmark of our technology platform is that our manufacturing processes are easily adaptable to producing other versions of the coronavirus spike protein that match the new strains. The company plans to begin clinical testing of these new vaccine candidates in the first half of this year.”

U.S. Rep. Diana DeGette (D-CO), chair of the panel, expressed concern that there is not currently enough product to vaccinate all adult Americans. “Our most pressing problem we have now is the lack of vaccine doses,” she said. “Some of the companies we have here are still short of the doses they promised when they testified in July.”

The three executives, along with representatives of Johnson & Johnson and AstraZeneca, assured the lawmakers that they have ramped up production in recent weeks to vaccinate every one of the 260 million American adults by the end of July, with those receiving Pfizer and Moderna products to get two doses. Pfizer’s Young said his company had delivered 40 million doses as of Feb. 17 and expects that volume to rise to 120 million by the end of March and a total of 300 million by the end of July. Hoge also said he expects Moderna to be able to deliver 100 million doses a month by the end of May. “We recognize the need to vaccinate more people more quickly,” said Young.

A third vaccine, a single-dose shot, is expected to be approved for emergency use authorization by the U.S. Food and Drug Administration (FDA) as soon as the end of this week, “At which point we’ll be able to begin distribution immediately,” said Dr. Richard Nettles, vice president of U.S. medical affairs, Janssen Infectious Diseases and Vaccines, at Johnson & Johnson. He said his company is “working around the clock to scale our production in the U.S., Europe, Asia and Africa.”

In the U.S., J&J will distribute its vaccine through an agreement with the federal government for the production of 100 million doses. J&J will deliver the vaccine to a distributor that will create a vaccination kit containing its vaccine and the necessary ancillary equipment, such as syringes and personal protective equipment.

 A top executive for AstraZeneca said his company had submitted data on its vaccine to the FDA and is ready to ramp up manufacturing to near capacity by the end of April.

Novavax’s Trizzino said his company is preparing to initiate production and distribution of 150 million doses a month by the end of June, pending regulatory approval.

These numbers are roughly consistent with projections of the Trump administration’s Operation Warp Speed, which contracted with the pharmaceutical companies a year ago for one billion doses of the yet-to-be developed vaccines.

“Because of the dire need to vaccinate more people, we have ramped up production of doses,” said Pfizer’s Young. “Since July, we have increased projected 2021 global production from 1.3 billion doses, to at least 2 billion doses. This is possible because Pfizer has made significant investments in our U.S. manufacturing sites including Saint Louis, Mo.; Andover, Mass.; Kalamazoo, Mich.; and Pleasant Prairie, Wis. In addition, we have added new lines at our site in McPherson, Kan., started lipid production at our site in Groton, Ct.; and added two contract manufacturers.”

Pfizer, he said, has also received approval from the FDA of a six-dose label for each vial, the doubling of batch sizes, increased yields per batch, and reduced cycle times, as well as deployment of faster laboratory tests to reduce release times, all aimed at stretching supplies of the vaccine.

Moderna’s Hoge said his company is on track to meet its original commitment of delivering the first 100 million doses to the federal government by the end of March. Earlier this month Moderna reached an agreement with the federal government to accelerate the delivery of the second 100 million doses and to deliver a third 100 million doses on an advanced schedule. “Since the end of 2020, we have doubled our monthly deliveries to the U.S. government, and we are working to double them again by April to more than 40 million doses per month,” he told the panel.

“It appears by mid-summer we may actually have a surplus of vaccines,” said U.S. Rep. Morgan Griffith (R-VA), who pointed out the U.S. will want to hold some supply in reserve for the possibility that additional dosages may be required. The surplus, he added, will allow the U.S. to share its supplies with other countries. “We do want to make sure that Americans are taken care of first but we do want to help out other countries. That way makes sure it doesn’t keep coming back to us.”

U.S. Rep. Frank Pallone (D-NJ), the chairman of the full committee, said according to experts the U.S. will need at least three million doses a day to “stay ahead of the virus.” He said $20 billion included in the COVID relief package making its way through Congress ought to help meet that goal.

The COVID relief package is expected to be voted on in a strict party line vote by the end of this week, then move to the U.S. Senate.

The experts also said their respective companies are researching the effects of the virus on children and whether a separate pediatric vaccine will be necessary. Pfizer, Moderna and AstraZeneca are all staging pediatric trials. Pfizer isconducting studies on patients between 12-15 years of age and plans to soon begin studies in children under the age of 11. Last week the company initiated a study in pregnant women.

Several lawmakers also questioned the terms under which the vaccines will be shared with undeveloped countries. “I’m concerned we are going to monopolize these vaccines at the cost to middle income and poorer countries,” said U.S. Rep. Jan Schakowsky (D-IL).

They also agreed that there is little evidence that vaccinated individuals may or may not spread a non-symptomatic version of the virus and are studying that possibility.