ROCHESTER, Minn. — On the day he announced that Minnesota would soon enter into a month of new restrictions meant to curb the spread of COVID-19, Gov. Tim Walz ended his speech on a promising note.
“We’ve got a light at the end of the tunnel,” he said. “I believe with every fiber of my being that there’s an incredibly strong possibility — more like a probability — that we will be vaccinating people before the end of this four-week pause in our long-term care facilities and our health care providers.”
There are reasons to be hopeful: After months of waiting, two coronavirus vaccines are poised to hit the market. The companies that make both — Pfizer and Moderna — say the vaccines are safe and very effective. Pfizer, which is developing the vaccine that’s furthest along, has applied to the Food and Drug Administration for emergency use authorization to distribute the drug.
The federal agency plans to review the application between now and Dec. 10 making it possible that the first vaccines could be administered in a matter of weeks. Moderna, which makes the second vaccine, is expected to make a similar request of the FDA soon.
State officials say their goal is to get most Minnesotans vaccinated. It’s the only way, they say, vaccines can prevent further the spread of COVID-19 and prevent more people from dying.
But even if Walz’s prediction is right, and the first shipment of vaccines lands in Minnesota by the end of the year, most Minnesotans won’t get their shots for months, as the state prioritizes inoculating health care workers and people at highest risk of dying from the virus.
Getting the vaccine from the manufacturing plant and into the arms of individual Minnesotans will be a massive logistical puzzle in which each piece must fall precisely into place. The state’s strategy will rely on coordination from its largest hospital systems all the way down to its smallest rural pharmacies.
And even then, unprecedented challenges around storage and distribution of the vaccine remain. In a year marred by distrust of public health professionals and disinformation about COVID-19, public health experts will also have to communicate to the public that the vaccine is effective and safe — and that it’s the nation’s best shot at getting back to some semblance of normal.
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A familiar path
At the Minnesota Department of Health, infectious disease and prevention director Kris Ehresmann is orchestrating Minnesota’s plans for vaccine distribution for months.
It’s in many ways a well-worn path for the department, which has a long history of disseminating vaccines effectively throughout the state — so much so that Minnesota was one of four states invited by the federal Centers for Disease Control and Prevention to participate in a pilot vaccine planning program earlier this year.
But it’s the speed at which the vaccine has been developed that is most remarkable to Ehresmann.
“The fact that we have two vaccines that are available and ready to be submitted to the FDA for evaluation 11 months after the genome was made available is incredible,” she said. “That in and of itself is a huge success story.”
She said that with the help of the federal government, vaccine manufacturers have been able to shrink the development timeline — for instance, the federal government has agreed to eat the cost of developing the vaccines, which has been an incentive to companies interested in developing them. If the vaccines failed, those companies wouldn’t be at a financial loss.
And the companies making the vaccines have been recruiting clinical trial participants on an accelerated timeline, while also showing federal regulators their vaccine testing data in real-time instead of after the testing process is complete, in an effort to expedite review.
But speed has also created a ripe environment for concerns over safety. Ehresmann said she fears even the name the Trump administration has given to the race to develop a vaccine may be misleading to the public.
“The concern we’ve had has been with an operation that’s been called ‘[Operation] Warp Speed’, that it’s given the wrong impression to the public that speed is the greater emphasis above safety,” she said. “In fact, we’ve joked that if we could rename it, we would call it ‘Operation Safe Speed.’”
Ehresmann pointed out that the vaccine trials have still been subject to the same safety evaluations as any other vaccine, and that a reporting system for adverse reactions to it will launch as soon as the vaccines are deployed
Front-line health workers first
Before Minnesota receives its first shipment of vaccine doses, a few things need to happen in Washington, D.C.
Once vaccines have been submitted to the FDA for emergency use authorization, the agency has two weeks to review the data related to its safety and effectiveness.
The next stop is the Advisory Committee on Immunization Practices, a body that makes recommendations on new vaccines to the CDC. The group assesses the effectiveness of the vaccine among different populations, and who is likely to benefit the most from it.
Once that committee makes its approval, which will likely take a few days, Ehresmann said it would be another week before “the vaccine is going into people’s arms.”
“Although we’ve been doing a great deal of planning, there are a lot of things that will be dependent on getting the details from the ACIP. We need to do protocols and training,” to be able to administer the vaccine safely, she said.
Ehresmann anticipates that front-line health care workers involved in the state’s COVID-19 response will be among the first to be vaccinated in Minnesota.
And one of the first places the vaccine will likely arrive is Mayo Clinic in Rochester, Minn.
There, Dr. Melanie Swift, who is helping to lead Mayo’s vaccine delivery strategy, is working on plans to get the vaccine to doctors, nurses and other medical personnel who have the most day-to-day exposure to COVID-19. The strategy is part of Mayo’s efforts to bolster its front-line workforce taking care of patients with COVID-19.
From there, Swift said she anticipates the vaccine would be available to people with high-risk health conditions or people who live in long-term care facilities. By the time the most at-risk health care workers are vaccinated, Swift said, she anticipates the vaccine makers will have ramped up production significantly.
“Ultimately, we do think that [the] vaccine will be plentiful ... at some point in the coming year,” she said. “It’s not a matter of planning for vaccine shortage, it’s just planning for gradual introduction starting with the groups at greatest need.”
Layers of complexity
Among the logistical challenges of distributing the two vaccines in the pipeline — and particularly the Pfizer vaccine — is that they are fragile and require special handling.
The Pfizer vaccine must be stored at minus 80 degrees Celsius — an unusually cold temperature for a vaccine, Swift said. The Moderna vaccine requires cold storage, too, but not as frigid.
And while Mayo has the ability to store both vaccines safely, Swift said, other challenges remain: Both vaccines require that a patient is administered two doses, weeks apart. Both doses need to be of the same vaccine — either the Pfizer one or the Moderna.
“The vaccines are not interchangeable. If you get vaccine A for dose one, you need vaccine A for dose two, as well,” she said. “That’s an additional layer of complexity that we haven’t seen in other vaccine products.”
Swift said Mayo is designing systems to make sure the correct second dose is provided at exactly the right time for it to be most effective.
Vaccines on the road
While Mayo and other large hospitals may already have some key infrastructure in place to receive and distribute the vaccine quickly, that’s not the case for every potential distributor in the state.
Cold storage — particularly of the Pfizer vaccine — will be a challenge for local public health entities assisting in vaccine distribution, said Jody Lien, public health director for Otter Tail County in western Minnesota.
Lien’s county is part of a regional health care coalition looking at ways to find and share cold storage — freezers that are significantly colder than commercial freezers.
The storage requirements are top of mind for Lien and her staff in part because her county is so rural, so storing the vaccines safely in transport and for long enough will be critical. Pfizer has developed packaging for its vaccine that keeps doses cold with dry ice, which means it can be stored for a few weeks safely.
“For Otter Tail County, our geographic size is a factor to navigate in getting [the] vaccine out to our communities,” she said. “We will need to ensure equitable access alongside assuring proper storage and handling — which really is dependent on what vaccine we receive.”
But Lien said her department has also found successful ways to make sure distance isn’t a barrier to vaccination — particularly for underserved communities, which may lack transportation to travel long distances to get the vaccine. Lien’s county has circumvented this problem in the past by partnering with schools and other community services in rural areas of the county.
And sometimes, the vaccines might come to the patients, she said.
For instance, Lien’s department has for years worked to build its relationship with Amish communities in the area — communities that are less likely to use traditional health care systems — and it’s a relationship she said public health workers there will likely rely on again.
“We communicate via a letter to households on a date that we plan to come to their community,” she said. “On that day our staff will go to various households, offer education and vaccinate family members that are in need.”
These strategies, she said, make it easier for people to get vaccines — and build trust in communities that might otherwise be hesitant to vaccinate.
In Crow Wing County, public health supervisor Michelle Moritz is grappling with similar challenges, and is looking at ways to bring the vaccine to people who might otherwise have trouble accessing it.
“Poverty can impact an individual’s ability to seek medical care and have transportation,” she said. “In our planning we will work to limit these barriers by bringing vaccine clinics to the community, and seek transportation services to bring people to the clinics if they do not have transportation.”
Another concern for Moritz: “Yet to be known is if the community is ready and willing to accept the vaccine.”
Disinformation an uphill battle
Back at the state department of health, Ehresmann and her staff are thinking through the same questions.
The introduction of the new vaccine is playing out against a backdrop of vaccine hesitancy among some communities, including those who think vaccines cause autism, which isn’t true. After months of marinating in disinformation about COVID-19, including falsehoods that it’s no more serious than the seasonal flu, will people distrust the vaccine as well?
And how will health officials reach communities of color or people who don’t speak English to inform them about the vaccine — the very communities who are at the highest risk of getting the virus, and dying from it?
“Our goal is to provide consistent messaging about the safety of this vaccine so people know the information we have about how the vaccines work, but it’s going to be an uphill battle,” Ehresmann said.
In early next year, her department is also planning a statewide public information campaign.
In the meantime, the state is working with individual communities to share accurate information about the vaccines early.
For instance, the Health Department is conducting a series of webinars for health care workers about the vaccine so they can accurately talk to their patients about it.
And it’s working to get information about the vaccine out through trusted community leaders and media outlets in underserved populations — people who may justifiably distrust vaccines because of their history of being exploited by the medical community. The information will be provided in multiple languages, too.
The stakes are monumentally high.
Ensuring that most Minnesotans are vaccinated is critical, Ehresmann said, because it’s the safest way to herd immunity short of letting the virus take its course in the population, which would lead to many more deaths.
A vaccine would create widespread immunity to the virus, making transmission from person to person unlikely.
“People ask, ‘What’s the end game for COVID?’” she said. “Vaccination really is the endgame.”