Vaccine readiness is tricky for states
Planners struggle over distribution
As states race the clock to ready their vaccination plans by a federal deadline Friday, they are grappling with a multitude of logistical hurdles, including not knowing which virus vaccine they will be distributing or when — or even if — one will be forthcoming.
President Donald Trump has left to local leaders much of the job of readiness for distribution of covid-19 vaccines, but it’s been impossible for states to fully prepare when, for instance, safe storage and transportation requirements will differ vastly depending on which of the four front-runner vaccines will be approved.
“It’s an extremely stressful time, trying to pack a very enormous planning task into 30 days,” said Claire Hannan, executive director of the Association of Immunization Managers, whose members include state health officials focused on vaccinations.
Distributing a vaccine on
a national scale has never been an easy task. Now, in the fog of the pandemic and with political pressure from the White House to pick up the pace, the job has become mind-boggling for state planners.
Among the decisions they must quickly resolve: directing transport from manufacturer to hospitals, physician practices and clinics; determining who will receive the first doses; and coming up with a strategy to convince increasingly skeptical citizens the shots are safe, all with little guidance from Washington.
“Different states are doing 50 different training programs and 50 different messagings on why the vaccine is critical,” Hannan said. “We really need that from the top.”
State and local health departments are veterans of vaccine campaigns. They played a crucial role in the 2009 H1N1 pandemic, and they help protect residents from the flu every year. But this operation provides a whole new level of complexity.
DIFFERENT DIRECTIONS
Demands from a myriad of agencies, under the federal Operation Warp Speed initiative, are challenging states’ ability to comply, officials and experts say.
“The federal government is insisting on strict requirements that states must meet,” without doing much to help local leaders get the job done, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. Osterholm is advising the state on its preparations.
“The issue here is trying to merge a federal top-down direction with what is largely a bottom-up delivery system,” Osterholm said. “That’s the conflict you’re seeing right now.”
States, for instance, are already strategizing on whom to vaccinate first, though they have no final recommendations from the federal government.
A panel of immunization experts that advises the Centers for Disease Control and Prevention will make recommendations for who should first receive a covid-19 vaccine once a shot is authorized by the Food and Drug Administration. The panel has met to discuss the potential scenarios but won’t vote on the recommendations until a covid-19 vaccine has FDA clearance.
The panel, known as the Advisory Committee on Immunization Practices, will convene an emergency meeting as soon as the FDA moves on a vaccine, said Jose Romero, chairman of the panel.
“That emergency meeting can occur as early as the evening of the announcement date or the next day,” said Romero, who also serves as Arkansas’ health secretary.
States are planning based on recommendations from the National Academies of Sciences, Engineering and Medicine, which call for starting with front-line health care workers. That sounds easier than it is, said Bob Swanson, director of the division of immunization at the Michigan Department of Health and Human Services.
“You have your hospital health care workers, your private clinic health care workers, you have your pharmacists, your urgent care, your local health department health care workers, long-term care health care workers,” he said. “You need to figure out how you’re going to get the vaccine to” all those groups, he said.
Essential workers are also near the front of the line, but the definition of those workers can vary greatly by state.
“That might be different in New York where it might be transportation workers,” said Dr. Jennifer Dillaha, Arkansas’ epidemiologist and medical director for immunizations. “In a rural state like Arkansas, it might be poultry processing plants.”
DISTRIBUTION CONCERNS
Getting the vaccine to those workers will be no easy task. Pfizer Inc. and BioNTech SE’s candidate, one of the vaccines furthest along in clinical trials, needs to be kept about 94 degrees below zero. The company plans to ship temperature-controlled containers filled with at least 1,000 shots directly to providers, solving a storage issue but posing a problem for rural states that need to spread those doses out.
States are responsible for tracking who receives which vaccine, when and where. Most of the leading candidates require two doses weeks apart, adding another layer of complexity to the already challenging effort.
The CDC is offering an app, but some states are wary of using it because they haven’t been able to test it themselves or have already invested in their own systems, Hannan said.
U.S. health officials are planning extra scrutiny of the first people vaccinated when shots become available — an added safety layer that experts call vital.
“I am very concerned about hesitancy regarding covid vaccine,” said Dr. William Schaffner, a vaccine specialist at Vanderbilt University who says even the primary care doctors who’ll need to recommend vaccinations have questions.
“If the politicians would stand back and let the scientific process work, I think we’d all be better off,” he added.
The stakes are high: Shunning a covid-19 vaccine could derail efforts to end the pandemic — while any surprise safety problems after one hits the market could reverberate into distrust of other routine vaccines.
On top of rigorous final testing in tens of thousands of people, any covid-19 vaccines cleared for widespread use will get additional safety evaluation as they’re rolled out. Among the plans from the CDC: texting early vaccine recipients to check how they’re feeling, daily for the first week and then weekly until six weeks have passed.
Any vaccine before Election Day is extremely unlikely. The Food and Drug Administration issued clear safety and effectiveness standards that shots must meet — and Commissioner Stephen Hahn insists that career scientists, not politicians, will decide each possible vaccine’s fate only after all the evidence is debated at a public meeting.
Dr. Anthony Fauci, the top U.S. infectious diseases expert, said that should be reassuring because it means scientists like himself will see all the evidence.
“So the chances of there being secret hanky-panky are almost zero because everything is going to be transparent,” he said.
Furthest along in final-stage testing in the U.S. are a vaccine candidate made by Pfizer Inc. and Germany’s BioNTech, and another developed by Moderna Inc. and the National Institutes of Health. Fauci said “the best bet” is that data about whether one or both work will emerge sometime in November or December.
DEMOCRATS’ CRITICISM
Meanwhile, a group of 100 House Democrats on Wednesday criticized the Trump administration’s unilateral approach to the coronavirus pandemic and offered a plan for working with other countries to control the crisis and ensure that vaccines can be shared widely and quickly.
A letter, written by Reps. Judy Chu and Brad Sherman of California and Jim McGovern of Massachusetts, says the Trump administration’s antipathy toward China and multilateral organizations hindered coordination with the World Health Organization and the European Union. It also says restrictions on scientific exchanges with Beijing resulted in fewer Americans on the ground in China as the virus began to spread.
“This impeded the ability of American public health officials to receive timely and accurate information about the pandemic, delaying our response and likely costing American lives,” the lawmakers wrote in the letter, addressed to Secretary of State Mike Pompeo and Health and Human Services Secretary Alex Azar.
The letter says the Trump administration’s refusal to join forces in “voluntary patent pools” and participate in international summits has “hampered global efforts to ensure that coronavirus treatments and vaccines, when developed, will be distributed to all who need them.”
In May, the European Union raised more than $8 billion, for developing and deploying a covid-19 vaccine, during a virtual summit that the United States did not attend. At the time, U.S. officials said the United States had already given $2.4 billion for the coronavirus response but did not provide a reason for not attending.
The letter also criticizes the administration for halting funding and announcing its withdrawal from the WHO, which “further isolated the U.S. from the world, and even from close allies.”
HEALTH FUNDING
In a response, a State Department spokesman said that although the Trump administration has halted funding to the WHO, the U.S. has invested $142 billion in global health systems since 2001.
“The ongoing global response to the covid-19 challenge is only possible because of decades of investment by the United States in health systems in countries across the world,” the spokesman said.
The lawmakers’ recommendations include rejoining several international initiatives, including joint vaccine research and production ventures; the distribution of essential medical equipment; funding for jobs programs to support contact tracing; and economic coordination.
Meanwhile, the World Bank has approved $12 billion in financing to help developing countries buy and distribute coronavirus vaccines, tests and treatments, aiming to support the vaccination of up to 1 billion people.
The $12 billion “envelope” is part of a wider World Bank Group package of up to $160 billion to help developing countries fight the pandemic, the bank said in a statement late Tuesday.
In Russia, authorities have given regulatory approval to a second coronavirus vaccine after early-stage studies, two months after a similar move prompted widespread criticism from scientists both at home and abroad.
Russian President Vladimir Putin made the announcement Wednesday during a televised meeting with government officials.
The scientists have yet to publish the results of the study.