In the first major hiccup of the rollout of the coronavirus vaccine, states this week found themselves scrambling to adjust as they received word they would get between 20% and 40% less vaccine next week than they had been told as late as Dec. 9.
States were given estimates that turned out to be based on vaccine doses produced, not those that had completed quality control and were releasable.Only on Wednesday and later were states informed of the actual numbers.
“The ripple effect is huge,” said Claire Hannan, executive director of the Association of Immunization Managers. “The planning piece is critical. We cannot roll this vaccine out on the fly.”
After three days of confusion, the source of the problem was finally clarified Friday night by Gov. Jay Inslee of Washington state. He tweeted he’d had a “very productive” conversation with Gen. Gustave Perna, chief operating officer for Operation Warp Speed, the administration’s COVID-19 treatment and vaccine program.
“That discrepancy was the source of the change in allocations,” Inslee tweeted. “It appears this is not indicative of long-term challenges with vaccine production.”
During a news conference Saturday morning, Perna explained that he had not taken into consideration the time it would take for completed vaccine to go through the full, rigorous Food and Drug Administration quality control process. FDA must receive a certificate of analysis for each batch 48 hours before the manufacturer can ship that batch, HHS tweeted Saturday.
Perna apologized to governors, saying it was entirely his fault.
“At the end of the day, I accept responsibility for the miscommunication,” he said.
“Where I failed – I failed, nobody else failed – is to have a clear understanding of that cadence. But when I applied it into our forecast methodology and our planning with the states, I realized that there was a delta to the numbers that I personally thought were available and ready for distribution and what was releasable,” he said.
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The sudden shift and lack of clarity for several daysrepresent a huge headache for states as they scramble to adjust their vaccination programs.
A letter sent to governors Friday night from Health and Human Services explained the discrepancy as confusion.
“We want to provide further perspective on the planning numbers generated in mid-November that are being compared with official weekly allocations. Official allocation numbers are only made available the week prior to distribution as they are based on the number of vaccine doses that have met FDA certification standards and have been released to the U.S. government,” it said.
“We hoped it was clear that those figures and the underlying projections from the companies were for planning purposes and could be refined, and that if the number of releasable doses from a manufacturer changed, the allocations to jurisdictions would change, too,” the letter went on to say.
That was in fact not clear to states. Governors nationwide have been asking for details and explanations since Wednesday.
“We are working to gain confirmation and additional details from our federal partners. It will take us some time to work through next steps and adjust our planning,” Iowa Department of Public Health spokeswoman Sarah Ekstrand wrote in a news release Wednesday.
In Michigan, Gov. Gretchen Whitmer said in a news conference that her state’s doses were being held up and that she couldn’t get anyone on the federal level to explain the discrepancies.
“I can’t get a call back,” she said. “I know that states across the country are grappling with the same thing, this isn’t just an issue here.”
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Oregon Gov. Kate Brown said on Twitter her state’s doses had been reduced by 40% and she was trying to get accurate information for week-to-week planning.
New Jersey was told it will receive 20% fewer doses than expected. “I don’t think we’ve gotten a satisfactory reason why,” Gov. Phil Murphy said.
In Massachusetts, a spokesperson for the state’s COVID-19 Command Center said Friday morning that the state has been notified it will receive 17,100 fewer doses — a 28% decrease from what it was expecting.
HHS had early given a slightly different explanation, saying it was a “misunderstanding.” In a statement Friday afternoon, HHS said there had been “some confusion between planning and training numbers provided in mid-November and actual official weekly allocations, which are only available the week prior to distribution.”
There was no confusion on their part, Washington state officials said.
The state was told as recently as Dec. 9 that it was getting 74,100 doses of the vaccine, said Mike Faulk, press secretary for Gov. Inslee.
“The 74,100 number was provided multiple times in multiple forms – by phone, email and in the federal database. It was provided in an email directly from Operation Warp Speed to the Department of Health,” Faulk said. “This is not a ‘mid-November’ number,” he said.
Then on Wednesday, Washington officials got a call from the Centers for Disease Control and Prevention telling them the number of doses they would be getting next week would instead be 44,850. No explanation for the reduction was given.
This was highly disruptive and threw weeks of work into disarray.
“Regardless of our allocation, we need predictability and accuracy so we can properly plan to make sure our vaccine effort is successful,” said Casey Katims, Inslee’s director of federal affairs.
The discrepancy represents a major breakdown in communicating the most essential information states rely on for vaccine rollout, said Dr. Kelly Moore, associate director of immunization education with the Immunization Action Coalition.
“The number one question you have if you’re a state vaccination program is: ‘How many doses do I have?’ Everything you do flows from the answer to that one question,” she said.
A last-second change of this magnitude in states’ vaccine projections represents “an unforced error,” she said, referring to a missed point in tennis due to a player’s own blunder and not their opponent’s skill.
“The states are real people making real plans based on the numbers. They deserve the truth, whatever it is,” she said. “They can handle it. What they can’t handle is a 40% drop with less than a week’s notice.”