Quality control reduced shipments of vaccine
In the first major hiccup of the rollout of the coronavirus vaccine, states last week found themselves scrambling to adjust as they received word they would get 20% to 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 clarified Friday by Washington Gov. Jay Inslee, who tweeted that he 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 wrote. “It appears this is not indicative of longterm challenges with vaccine production.”
Perna on Saturday said it was his fault.
“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 (change) to the numbers that I personally thought were available and ready for distribution and what was releasable,” he said.
The sudden shift and lack of clarity for several days represent a headache for states left to adjust vaccination programs.
A letter sent to governors Friday 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,” the letter 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.”
That was not clear to states. Governors nationwide had asked 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 said in a statement Wednesday.
Michigan Gov. Gretchen Whitmer said 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.”
HHS had early given a slightly different explanation, saying it was a “misunderstanding.” In a statement Friday, 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 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,” Faulk 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.
That was 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 vaccine in question was the formula developed by Pfizer Inc. and Germany’s BioNTech.