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.
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.
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?”
Deep Freeze challenge
Only two of six vaccine candidates that have the backing of the federal government — from Moderna and Pfizer — are currently in active Phase III clinical trials, and both require individuals to take two doses, three to four weeks apart. Both also require complex cold shipment and storage conditions.
A third vaccine from AstraZeneca, which must be maintained in minus-20 degrees storage conditions, entered Phase III trials in the United States on Monday, but has recruited only three dozen people so far, Corey said.
Moncef Slaoui, the head of Operation Warp Speed’s vaccine development program, told a panel of independent experts on Aug. 7 that the only vaccine candidates which could possibly emerge for distribution by the end of this year were the vaccine candidates that had Phase III clinical trials already underway.
“We set ourselves the timeframe of having the vaccines available by the end of 2020 or early 2021, which means they have to be in Phase III trials as we speak,” Slaoui said, before the AstraZeneca trial began. Other vaccine candidates that enter Phase III trials in October and November will not be approved and distributed until the middle of 2021, he added.
Documents obtained by McClatchy show concern within the CDC over the distribution challenges posed by the leading vaccine candidates.
“Diverse cold-chain or ultra-low temperature requirements can substantially affect implementation efforts,” states one Aug. 26 presentation from the agency’s vaccine working group. Another notes that vaccines requiring dry ice delivery are “only shippable to large admin sites.”
Pfizer said it is producing its own shipping containers for the vaccine. McKesson, the company that will serve as the central vaccine distributor, is preparing its own low temperature shipping equipment for the Moderna vaccine.
Wheeler said that cold chain shipping containers are being manufactured to maintain the vaccines for up to 96 hours, or four days, for quick use. He expects the first wave of vaccines that require ultracold storage and shipment conditions to be delivered directly to the vaccine provider given the limited number of doses that will be available early on.
Wheeler said that, for deep frozen vaccines requiring minus-80 degrees Celsius shipping and storage conditions, dry ice will be readily available. “These will be almost hand-to-mouth shipments. So we’ll be getting orders to ship overnight to a nursing home, or a senior living facility, or a vaccination center of some kind or hospital, or they’ll have people lined up ready to be vaccinated.”
The Moderna vaccine will ship at minus-20 degrees Celsius and “will not require dry ice,” Ray Jordan, head of corporate affairs at Moderna, told McClatchy. “After thawing, to facilitate storage at the points of administration, we expect to allow refrigerated conditions of 2-8C (36-46F) for up to about a week.”
Operation Warp Speed officials have told distributors to expect the elderly — including those homebound, in nursing homes and in senior living facilities — as well as health care workers, frontline essential workers, national security workers and communities of color, to be among the priority groups for the first vaccine doses.
But how those groups will be ranked remains a critical open question. “Nobody seems to know where and what order these people will be vaccinated,” Wheeler said.
Highly targeted deliveries could work in the initial phase of vaccine distribution, when there are extremely limited quantities of vaccine shipped in a targeted manner to those deemed most in need.
But that will not be a sustainable model as the government ramps up deliveries on a massive scale, experts warned.
“Two of the leading candidates will require ultra-freeze. We have the capability to do ultra-freeze at select locations in the country at high volume,” Yadav said. “But then it’s a question of, how many doses can we store at ultra-freeze at a large hospital? That’s where the constraints start coming.”
Small provider locations — such as physicians’ offices and pharmacies — could simply receive one day’s worth of vaccine, replenished regularly by larger centralized distribution centers maintained by the state or Defense Department, Yadav said.
“But that puts a lot of strain on the distribution system,” Yadav continued. “Taking hundreds of thousands of vaccine to hospitals from a distribution center is not an activity that our three big distributors have ever carried out at that scale.”
A spokesperson for CVS Pharmacy, which is expected to play a role in the distribution of a vaccine, said that company leadership has “been having discussions with the administration on the important role we can play.”
The company said its experience in distributing the seasonal flu vaccine would “help inform” its plans. But it declined to respond to questions on its preparedness for a vaccine that requires storage in sub-zero temperatures.
Concern in rural areas
Rural areas of the country that have struggled throughout the coronavirus pandemic with financially strained health systems will now face yet another test.
In Kansas, the state health department is already warning that mass distribution of a vaccine requiring ultracold storage will be “impractical” for large portions of the state.
“It will be a real challenge if we have to have things under dry ice. That’s not within a lot of clinics and health centers and rural facilities,” said Dr. Lee Norman, secretary of the Kansas Department of Health and Environment.
“In laboratories and hospitals and things like that, we have that,” Norman said. “But when it comes to pushing those out in the community, that will be tough.”
The more demanding the distribution requirements for the vaccine candidate, the harder it will be to push out on a massive scale, said Dr. Howard Koh, former assistant secretary for health under President Barack Obama and now at the Harvard T. H. Chan School of Public Health.
“This is where a strong public health department, particularly at the local level, is critical,” Koh said. “And one of the challenges we’re all seeing in the middle of COVID is the weaknesses in the public health infrastructure, mostly because there have been cutbacks and layoffs for years. This is going to be a test for that system.”
Swann, who co-founded the Center for Health and Humanitarian Systems at the Georgia Institute of Technology, has been in touch with local health officials throughout the country as they wait for more detailed guidance from Operation Warp Speed.
“I have not seen a plan that ensures vaccines can be delivered safely or in a transparent, equitable manner,” said Swann. “I have not seen any plan that would indicate we are prepared to vaccinate millions of Americans virtually simultaneously.”
“States need to find the budget for each of the pieces that will be under their control,” Swann said. “If the states don’t know about the plan at this point, it’s unacceptable.”
In response to questions from McClatchy, an HHS spokeswoman, Natalie Baldassarre, sent a transcript of comments from Operation Warp Speed officials at an Aug. 28 telephone media briefing that McClatchy was not allowed to participate in.
Late messaging push
The success of the Trump administration’s messaging campaign around the launch of a vaccine could determine whether millions of doses of vaccine that are purchased and dispersed around the country are actually used — or sit unused, and possibly wasted.
Trust in the process appears to be declining. Only 42 percent of Americans surveyed by Yahoo News and YouGov in late July said they plan to get the COVID-19 vaccine, down from 55 percent in May.
Politico reported that HHS was bidding out a $250 million contract to a communications firm for a messaging campaign to “defeat despair and inspire hope” of a coronavirus vaccine. The HHS document said the vast majority of the contract would be spent before January.
Some experts are concerned that the Trump administration’s approach, which has frequently been in conflict with scientists and regulators, has sown distrust in whatever vaccine emerges.
“We need a lot of outreach and encouragement for people to take this vaccine, which many consider to be having been rushed,” said Toner of Johns Hopkins. “That’s the message over and over again – this is ‘warp speed.’ Well, that’s not necessarily a reassuring message when you’re talking about something that’s being injected into your body.”
“I think there will be a lot of hesitancy,” Toner added. “I think it’s completely tone deaf.”
Jonathan Shorman with the Kansas City Star, Sophia Bollag with the Sacramento Bee and Mary Ellen Klas with the Miami Herald contributed to this report.