WASHINGTON — Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, sent a letter last week to the nation’s governors with an urgent request. The Trump administration wanted them to do everything in their power to eliminate hurdles for vaccine distribution sites to be fully operational by Nov. 1.

The Aug. 27 letter, obtained by McClatchy, asked governors to fast-track permits and licenses for new distribution sites. “The normal time required to obtain these permits presents a significant barrier to the success of this urgent public health program,” Redfield wrote.

“CDC urgently requests your assistance in expediting applications for these distribution facilities,” he continued, “and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.”

“The requirements you may be asked to waive in order to expedite vaccine distribution will not compromise the safety or integrity of the products being distributed,” he added.

CDC Director Redfield sent a letter to governors "urgently" requesting them to expedite applications for vaccine distribution facilities and waive requirements that would prevent them "from becoming fully operational" by November 1, @CBSNews confirms.First reported by @mcclatchy pic.twitter.com/nFrS7vpA3W

— Sara Cook (@saraecook) September 2, 2020

It was the latest hurried federal request of state governments to prepare for the arrival of a vaccine for covid-19, the pandemic disease that has killed roughly 185,000 Americans.

Last month, Dr. Nancy Messonnier, a top CDC official working on the federal coronavirus response, warned that state public health departments are “running out of time” to draft plans for the distribution of covid-19 vaccines — and requested states submit proposals by Oct. 1.

Delivery firms have received guidance from Trump administration officials to prepare freezer farms in the heartland and get ready to load vaccines onto trucks no later than Nov. 1.

The rush is putting pressure on state health systems already strapped for resources — and appears out of sync with the progress of ongoing clinical trials for coronavirus vaccines, which are still recruiting volunteers who will test the safety and effectiveness of the drugs.

Some supply chain experts are expressing concern that Trump administration officials with “Operation Warp Speed,” the federal program accelerating vaccine development, have failed to adequately communicate the responsibilities that state and local governments will take on once the logistically demanding task of distributing a covid-19 vaccine is upon them.

“At this point, we should know much more about what the intended distribution system looks like, and what the plan is,” said Dr. Julie Swann, head of the Department of Industrial and Systems Engineering at North Carolina State University and an adviser to the CDC during its response to the H1N1 pandemic in 2009.

JUST IN: According to the New York Times, the CDC has notified states to get ready to distribute a vaccine by October or November. This raises questions on the political timing of the vaccine delivery. pic.twitter.com/BlLWSl9HBE

— MSNBC Live with Ayman Mohyeldin (@AymanMSNBC) September 2, 2020

The first vaccines most likely to emerge from Phase III clinical trials will pose exceptional challenges to public health officials, requiring storage in sub-zero temperatures and two doses per individual spread weeks apart.

Others have expressed concern that the timeline set out by Operation Warp Speed — setting a deadline that would offer the first vaccines to Americans just days before the presidential election — is motivated by politics over science.

Warp Speed officials have told reporters to expect an “overwhelming” public messaging campaign come November. And at the Republican National Convention last week, President Donald Trump, Vice President Mike Pence, and White House senior adviser and the president’s daughter Ivanka Trump all touted the Warp Speed program, claiming a vaccine could be approved before the end of the year.

Wes Wheeler, president of UPS Healthcare, said in an interview that guidance from the administration is to be ready to put the vaccine on trucks by Nov. 1. “It will be preceded by a practice run — we’re talking about having early discussions in September and October about how this will actually work,” he said.

“I think we’ll all be given instructions on how it will work — we haven’t seen that yet,” Wheeler said. “They’re talking about ten million doses in November.”

Dr. Larry Corey, who is co-leading the coronavirus vaccine clinical trials for the covid-19 Prevention Network under the National Institutes of Health, told McClatchy this week that he does not expect results from the trials to be ready for approval or delivery by that time.

“All the trials are designed, if everything goes well, to get an answer about seven months from the time that the trial starts,” Corey said. “Vaccines with 90% efficacy will give a readout sooner than with 50% efficacy, but I would still say that it would require probably the difference between five months and seven months.”

The first Phase III trial began in mid-July, making it extremely unlikely his team could fully enroll the volunteers, provide each volunteer with two doses, track their progress and reach conclusions by November, Corey said.

“It’s incredibly important for our country and the world to know which vaccine works, how well it works,” said Corey, a virologist at Fred Hutchinson Cancer Research Center. “They look like they’re going terrifically well, and what we need is to let science take over, because without that, we have no public policy.”

Pilot programs complete

CDC coordination with states picked up over the last month.

The CDC’s vaccine working group met weekly throughout August to review potential scenarios for the initial distribution of a vaccine. They modeled allocation strategies, weighed how to prioritize who gets the vaccine first, and reviewed data from the initial clinical trial phases of the leading vaccine candidates.

Weekly calls with state health officials began on Aug. 17, and last week, the CDC completed pilot programs with five jurisdictions — California, Florida, North Dakota, Minnesota and the city of Philadelphia — that will serve as models for operations across the country.

Those pilot programs “will be the foundation for every jurisdiction in the United States as they develop their plans next month for vaccine availability,” Redfield told reporters in a briefing on Friday.

CDC officials have told state public health officials to expect a “state operations guide” within days that is over 100 pages long. The document will help them begin preparing their own plans, and will outline a phased approach to vaccine distribution.

State health officials have been waiting for more detailed federal guidance for weeks.

“The federal government is in the process of providing the California Department of Public Health additional guidance on the distribution of vaccines and information to help clarify the division of responsibilities,” the California department told McClatchy in a statement.

But the CDC will begin “microplanning” with states this week, asking them to survey local facilities that already have the capacity to store vaccines in ultracold settings, and issuing reporting guidance more strict than what was required during the 2009 H1N1 pandemic.

“We need to determine how much vaccine will go to each state or each jurisdiction, and distributing it to the states is granular work to figure out how the vaccine is going to move from the manufacturer to the distributor to the state, the vaccine location, and then into the arms of individuals,” Redfield said.

Experts argue it is unrealistic to expect cash-crunched states to plan multiple contingencies for mass vaccinations within a matter of weeks.

“I haven’t seen anything so far that’s given me a lot of confidence,” said Dr. Eric Toner, senior scholar at the Johns Hopkins Center for Health Security whose framework for distributing covid-19 vaccines was cited as a resource by the National Academy of Medicine. “It is concerning to me.”

States will need to compile immunization registries — typically only kept for children — on adults, in order to track who has received their first dose and who requires a second. That data will have to be shared on a constant basis with central distributors to ensure that a recipient’s second dose arrives on time at the right location. And those locations will have to be identified in advance, with an ability to store the vaccines in sub-zero temperatures.

“If we are doing this as a mass vaccination campaign, in the parking lots of hospitals, then you’re seeing the person who is giving you the vaccine for the first time in your life,” said Prashant Yadav, a supply chain expert at the Center for Global Development and former supply chain strategy leader at the Bill & Melinda Gates Foundation. “Then for the second dose, you would have a reminder from the county public health department or some other agency to go back, and would you go back to the same location? Or a different location?”

“Those are information and logistical questions that remain unanswered, and they’re unanswered because there is no plan,” Yadav said. “So many of the details are missing that many state officials are still struggling to say, yes, the CDC is asking us to do these things — but we don’t know how much will be given to us, on what schedule, so what are we planning for?”

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