A Blog by Jonathan Low


Dec 19, 2020

Confusion and Finger Pointing As States, Feds Confront Covid Vaccine Delays

The state authorities charged with distributing the Covid vaccines are saying they are now being told they will get almost 50% less than they were originally promised. The Federal government is blaming Pfizer for  production delays and the states for changing how they want it delivered. 

Both Pfizer and the states are blaming the Feds for overpromising, bureaucratic infighting and political interference. JL

Isaac Stanley-Becker and colleagues report in the Washington Post:

Officials in multiple states were alerted that their second shipments of Pfizer-BioNTech’s vaccine had been drastically cut for next week, sparking widespread confusion and conflicting statements from Pfizer and federal officials about who was at fault. Pfizer said (it) faced no production difficulties and had many more doses available than were being distributed.Pfizer executives were baffled that the administration was not immediately distributing all of its vaccine, instead leaving much of it on the shelves.

Officials in multiple states said they were alerted late Wednesday that their second shipments of Pfizer-BioNTech’s vaccine had been drastically cut for next week, sparking widespread confusion and conflicting statements from Pfizer and federal officials about who was at fault.

The reduction prompted concern in health departments across the country about whether Operation Warp Speed, the Trump administration’s vaccine accelerator program, could distribute doses quickly enough to meet the target of delivering first shots to 20 million people by year’s end.

A senior administration official, speaking on the condition of anonymity to discuss internal plans, said the revised estimates were the result of states’ requesting an expedited timeline for locking in their allocations for the following week; notification of how many doses they could order each week was consequently advanced from Friday to Tuesday. Since Pfizer is producing doses daily, the official said, fewer doses were available Tuesday than will be available on Friday.

But Pfizer released a statement Thursday that seemed to contradict that explanation, saying the company faced no production difficulties and had many more doses immediately available than were being distributed.

“We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses,” the statement read.

The clashing accounts came as Pfizer and the Trump administration negotiate over additional vaccine doses for the United States. Pfizer, which has already committed to providing the government 100 million doses, said that as recently as October, federal officials had turned down its entreaties to lock in another 100 million doses. When those officials sought to buy those doses later, the company said its supplies were already committed to other countries. Now the pharmaceutical giant and the administration are nearing an agreement that would provide the United States with more than 50 million doses, but fewer than 100 million, probably spread over the second and third quarters of 2021, according to people knowledgeable about the negotiations who spoke on the condition of anonymity.

Health and Human Services Secretary Alex Azar, in a CNBC appearance on Thursday, noted that Pfizer had slashed its manufacturing projection for this year from 100 million doses to 50 million doses, and said he would “like to have more visibility” into the company’s manufacturing capacity.“I do wish we would stop just talking about this Pfizer thing,” Azar said, noting that other vaccines were in the pipeline.The company said the change, announced in November, had to do with difficulties procuring sufficient raw ingredients and noted in its statement Thursday that it had shared “every aspect of our production and distribution capabilities” in weekly meetings with federal officials.

Earlier this week, 2.9 million doses of the Pfizer-BioNTech vaccine were cleared for shipment, while 5.9 million doses of Moderna’s regimen are poised to go out next week if the vaccine is authorized, as expected. That will be on top of additional supply from Pfizer, which Azar said Wednesday would amount to 2 million doses next week.

UC Davis Health received its first shipment of the Pfizer-BioNTech vaccine on December 15, with emergency department employees receiving the first doses. (The Washington Post)

That represents a sharp drop-off from what states were expecting, according to state health officials. At least six states were informed by federal health authorities of the shortfall, forcing last-minute changes to vaccine distribution plans for next week. Some were intending to use the second shipment to begin vaccinating residents of long-term-care facilities, but they now face a dilemma about whether to go ahead with those plans or finish inoculating health-care providers, officials said.

Illinois Gov. J.B. Pritzker (D) said anticipated shipments to the state in the next two weeks had been cut roughly in half. The uncertainty was even more pronounced in Florida, where Gov. Ron DeSantis (R) said new shipments from Pfizer were “on hold,” as officials in his administration reported their expected allocation disappearing entirely in Tiberius, the online tracking system the federal government uses to coordinate vaccine distribution with the states. Fred Piccolo Jr., a spokesman for DeSantis, said the numbers had come back online by Thursday but had been reduced significantly.

“It’s 40 percent less than we were originally thinking,” Washington state Health Secretary John Wiesman said. “We thought we were getting 74,100 and now we are planning for 44,850 doses.”

Maine said it is receiving about 40 percent fewer doses than expected — 8,775 rather than 13,650. The state will not be able to fully launch its program next week to vaccinate residents and staff of all long-term-care facilities, said Robert Long, a spokesman for the Maine Center for Disease Control and Prevention.

Michael Pratt, an HHS spokesperson, denied any changes to “numbers locked in with states” and said the government was still on track to allocate enough vaccine for about 20 million people to receive their first doses by year’s end.

“Each week, [Operation Warp Speed] will let states know how many doses are available to order against for the coming week,” he said.

The senior administration official said moving up the notice to Tuesday was the reason for the one-week shortfall, as “we are sending doses that have been produced, verified and released.”

Wiesman, of Washington state, said he could appreciate Operation Warp Speed’s decision to provide numbers of verified doses only, as opposed to an estimate of what might be available by week’s end. But he said states can’t plan without a longer-term sense of what they will receive, which has been impossible because of changing estimates from the pharmaceutical companies and from Operation Warp Speed.

“We need to have some sense of what regular production is going to be, what the throughput of the manufacturer is so we can look more than a week ahead,” he said.

Some of these concerns were communicated on a call last week with governors and administration officials, including Vice President Pence, Azar and Gustave Perna, chief operating officer of Operation Warp Speed. There was only preliminary guidance on shipments for this week, said a state official who participated in the call. Administration officials, peppered with questions about the initial supply of the Pfizer-BioNTech vaccine, emphasized the Moderna vaccine, which they said would be available soon.

FedEx and UPS are distributing the Pfizer vaccine, while Moderna’s product will be moved by McKesson, a major medical distributor. Both vaccines are two-dose regimens, and the Trump administration has elected to hold back shipments of the second dose in an effort to ensure everyone gets their second shot.

Another person involved in the planning, who spoke on the condition of anonymity because they were not authorized to discuss the situation, said Pfizer executives were baffled that the administration was not immediately distributing all of its vaccine, instead leaving much of it on the shelves.

In one bright spot for hospitals receiving the initial shipments of the Pfizer vaccine this week, some health-care providers discovered that they could get as many as seven doses out of vials they were told contained only five doses of the precious vaccine.

The Food and Drug Administration advised hospitals to use the additional supply, while Pfizer said the amount of vaccine remaining in the vial after five doses may vary, instructing health-care providers to consult their own immunization policies.

One complicating factor was that companion kits shipped to vaccination sites by the federal government did not contain many spare syringes needed to give the excess doses. The administration official said additional materials will be included in the future kits to accommodate additional doses that can be drawn from the vials of Pfizer vaccine.


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