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State’s ambitious vaccine campaign hinges on more companies winning FDA approval

Vaccinating 5 million residents depends on factors beyond Massachusetts’ control

Registered nurse Winter Drury cared for a patient in the COVID intensive care unit at UMass Memorial Medical Center in Worcester.
Registered nurse Winter Drury cared for a patient in the COVID intensive care unit at UMass Memorial Medical Center in Worcester.Craig F. Walker/Globe Staff

The success of Governor Charlie Baker’s plan for the largest public vaccination in Massachusetts history hinges on critical factors outside the state’s control, including approval of more COVID-19 vaccines in addition to the two developed by Pfizer and Moderna, health officials said Thursday.

Without more vaccine choices, the state may be hard pressed to get enough doses to meet its goal of immunizing more than 5 million residents against the fast-spreading coronavirus by the middle of next year.

Baker administration officials so far have estimated shipments of a little over 2 million vaccine doses, enough to fully vaccinate slightly more than a million people. That’s a fraction of the more than 10 million doses they’ll need to inject most adults in the state with the two required shots. The second dose is injected three to four weeks after the first.

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Supply could be “a limiting factor” in the success of the vaccination campaign, Kevin Cranston, assistant commissioner of the state Department of Public Health, told the state Public Health Council on Thursday.

Cranston said state officials are confident about receiving a sufficient supply to vaccinate the most vulnerable residents, but he also acknowledged that many assumptions are built into their timetable.

“We’re planning on multiple vaccine formulations [being] approved by FDA,” Cranston said. “We are basing this [vaccination plan] on assumptions of approval and manufacturing capacity that all still have to be demonstrated.”

More than 200 COVID-19 vaccines are in development around the world, but only the vaccines made by Pfizer and Cambridge-based Moderna are on the verge of federal approval in the United States. Pfizer’s vaccine could be approved for emergency use by the Food and Drug Administration this week, while Moderna’s could win FDA emergency approval next week. All of the state’s anticipated shipments so far are coming from those two companies.

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State officials say they expect to secure additional shipments of vaccines from both companies and others as they are approved throughout 2021, but they don’t have specific commitments yet.

“The federal government has not provided us with a shipment schedule,” said a spokesperson for the Baker administration’s Command Center, which handles the state’s COVID-19 response. “Our estimates are based upon our conversations with the federal government and could change as we get more information.”

Some Public Health Council members expressed nervousness Thursday about the “scalability” of the vaccine rollout and potential supply shortages.

“I just want to make sure we have enough [vaccine] supply . . . working for us,” said Dr. Edward Bernstein, a health council member who is professor of emergency medicine at the Boston University School of Medicine.

Council member Kathleen Carey, a health economist at the Boston University School of Public Health, called the state plan encouraging, but worried about raising expectations. She noted that the state is depending on the federal government to deliver millions of vaccine doses from various manufacturers.

“Is there uncertainty around this timetable? We’re taking about confidence in the general public,” said Carey.

State health officials said they expect to have enough Pfizer and Moderna vaccines by early 2021 to inoculate about 600,000 people given priority designation in Phase One: front-line health workers, senior care residents, public safety employees, home-based caregivers and other health workers, and residents of congregate settings like prisons and homeless shelters.

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After that, state planners said, they’ll depend more on additional vaccines coming on line. Federal officials, who are coordinating distribution with the states, have ordered 800 million vaccine doses from six drugmakers — including 100 million each from Pfizer and Moderna — that are manufacturing the vaccines even as they work their way through the FDA approval process.

“They’re all in the process of manufacturing right now,” Cranston said. “So the longer we stretch out until January, February, March, and further, the more vaccine will be on hand to be allocated” as the FDA clears the new vaccines for use.

Assuming the Phase One residents can be vaccinated by February and the state can obtain additional supplies, Massachusetts would move on to inoculating the Phase Two priority group: residents with two or more chronic health conditions, critical workers such as teachers, transit employees, and food and sanitation workers, adults 65 and over, and residents with a single serious illness.

Cranston said there may be some flexibility and variation in how the phases of the vaccine program are carried out. Shots may be available for some in the second phase even before the first phase is complete, and there could be “rolling implementation” within the phases, he said.

Those who aren’t part of the higher-risk categories would be given vaccine shots later. “We are hoping by springtime there will be sufficient vaccine to vaccinate the general population,” Pejman Talebian, director of the DPH immunization division, told health council members.

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The nation’s vaccination strategy relies on the availability of multiple successful vaccines. Operation Warp Speed — the Trump administration’s ambitious effort to accelerate the development of coronavirus vaccines — has fallen far short of an early pledge to deliver 300 million doses by January 2021.

Now federal officials estimate that 35 million to 40 million doses will be distributed by the end of this month, as long as Pfizer and Moderna’s vaccines are cleared by the FDA for emergency use. Operation Warp Speed officials say the United States should have enough vaccines to immunize 100 million Americans by March.

But the number of doses the country ultimately will receive is “a moving target,” said Josh Michaud, an associate director of global health policy at the Kaiser Family Foundation.

Manufacturing and supply chain constraints have lowered earlier estimates drug makers have provided to the federal government, leaving some states with fewer doses than they’d expected in their initial shipments, he said. The US government is allocating available doses to 64 jurisdictions, including states and territories, based on the size of their adult population, plus five federal agencies.

“We don’t know exactly how many doses because this is going to be an ongoing process,” Michaud said. “The estimates that Operation Warp Speed officials have put out there are pretty optimistic, and one can imagine that there will be obstacles and difficulties along the way, which might mean they won’t achieve their ultimate goal.”

Michaud said he expects supply to expand significantly in February, March, and beyond, as vaccine contenders from other manufacturers, like AstraZeneca and Johnson & Johnson, are evaluated and approved by regulators.

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If those vaccines are proven to be safe and effective, he said, “there will probably be enough vaccines in the US to vaccinate everyone who wants one” by the summer.


Robert Weisman can be reached at robert.weisman@globe.com. Follow him on Twitter @GlobeRobW. Deanna Pan can be reached at deanna.pan@globe.com. Follow her on Twitter @DDpan.