Hospitals across the country are ramping up their efforts to figure out how to store, track and administer coronavirus vaccine doses following the recent news that an effective vaccine could be on its way within weeks or months.
Hospitals will play a key role once a vaccine receives an emergency use authorization from the FDA, which could happen as soon as next month. They will move quickly to vaccinate their front-line healthcare workers and then their patients and surrounding communities.
But the task, like so much else related to the novel coronavirus, is unprecedented.
Hospitals will need to be in constant communication internally as well as with their group purchasing organizations, state and federal government agencies and their local communities. To add further complication, the FDA has multiple candidates for an EUA that require different storage and administration tactics.
And, each state and territory, along with six major metropolitan areas, has its own distribution plan that has to be approved by the Centers for Disease Control and Prevention. Those 64 plans are generally based on what was drawn up for distribution of the H1N1 vaccine more than a decade ago.
Much of the planning is already underway, but only so much can be done until an EUA is granted. Two vaccine candidates have so far said they have data showing efficacy at about 95% — one from Pfizer and BioNTech and the other from Moderna. The crucial raw data, however, have yet to be released for peer review.
But hospitals and health systems have a lot to work out before that time comes.
Houston Methodist Hospital created a coronavirus vaccine task force back in August, and at first there wasn't a whole lot to discuss, Katherine Perez, infectious disease specialist at the facility, said. The team includes members from the pharmacy, human resources, supply chain and operations departments.
It now meets more regularly to make the best effort to be prepared when the FDA clears a vaccine. Discussions have centered around acquiring proper storage equipment, how to determine what order workers and patients will get the shot and how to educate people about its safety and effectiveness.
With healthcare workers first in line for a vaccine, the process for hospitals will start as soon as a vaccine is approved, and Trump administration officials said this week they expect doses to be at the jurisdictions within 24 hours of approval.
"Hospitals have borne the brunt of this pandemic," said Julie Swann, health systems expert with North Carolina State University. "Hospital staff, the doctors and nurses, have just been overwhelmed in the ERs and the hospital wards. I'm glad they are among the priority groups for this vaccine and I'm hopeful that the vaccine will decrease the workload they have borne for this entire time."
Storage, cold chain requirements
The storage requirements will depend on the vaccine or vaccines that receive authorization. The Pfizer shot, for example, requires a temperature of minus 70 degrees Celsius for transportation and long-term storage — which is unprecedented in provider healthcare settings.
The Moderna vaccine's temperature needs are less stringent. It must be stored long-term at minus 20 degrees Celsius, the same temperatures used for the MMR (measles, mumps and rubella) and chickenpox vaccines, which doctors have been administering for decades.
Moderna's product can last at refrigerator temperatures for 30 days, whereas Pfizer's can be stable at those temperatures for only five days.
But without knowing if or when those vaccines or other candidates will receive an EUA, hospitals are doing their best to prepare for all scenarios.
Several difficulties surround acquiring the ultra-cold freezers needed to properly store a vaccine like Pfizer's. They can be hard to find right now, they're quite expensive and most facilities won't have another use for them.
"It's very, very infrequent where you're going to need to store something at this temperature so that's a pretty big investment if you're only going to do it once." said Mark Howell, senior associate director of policy for the American Hospital Association.
These freezers are typically custom-made and cost between $5,000 and $20,000 depending on the size. They usually take four to six weeks to be delivered, said Soumi Saha, vice president of advocacy for group purchasing organization Premier.
Many states require their board of pharmacy to inspect the freezers and mandate that continuous monitoring of their temperatures be performed in case there is a failure. Companies that perform that 24/7 monitoring are saying they don't have the capacity to watch the ultra-cold freezers, Saha said. "So some who have purchased these ultra-low freezers have run into some regulatory barriers," she said.
Houston Methodist has purchased a large amount of subzero freezers in anticipation of cold storage needs, Perez said. Larger hospitals and health systems will have that ability. But smaller hospitals don't have the same resources.
Smaller and rural hospitals will also have to wait longer to receive doses, which, because they are packed in dry ice, can only be transported on the ground. They are shipped with a minimum of 975 doses, which could present another problem for areas with lower populations, Saha said. "The logistical challenges are much more heightened in rural communities," she said.
Pfizer is shipping its vaccine in containers described as briefcases or pizza boxes. The doses are packed with the dry ice and can be kept for up to 10 days before needing to be repackaged or put into an ultra-cold freezer.
Those cases, however, can only be opened twice a day for up to one minute each time, meaning meticulous planning and execution will be required for efficient administration and avoiding waste, Saha said.
Smaller and rural hospitals could also find a community center or other location that could have the storage capability and double as an administration site. That would have the added benefit of being more convenient for people who don't want to travel far to get their shot, Howell said.
Administering the shot: staffing, training and security
Hospitals will begin giving shots to their own workers first, but most will have a tiered system for which staff will be first in line. Perez, of Houston Methodist, said her hospital has been going through the process of putting workers into categories based on factors like amount of direct patient interaction and which patients they tend to.
One consideration for hospitals is whether to make vaccination mandatory for staff, with certain exceptions for medical conditions. Houston Methodist may do so eventually, and already has the legal framework in place because workers are required to receive seasonal flu vaccinations already, Perez said.
Other hospitals aren't as likely to use a mandate. Atrium Health, a North Carolina-based system with about 40 hospitals, doesn't plan to, for example, said Lewis McCurdy, infectious disease specialist for the system. Saha said the legal implications for hospital liability are tricky, since healthcare workers will mostly be receiving the vaccine under an EUA and not full FDA approval.
The process will vary drastically depending on a hospital's location. "Montana's plan is going to be very different than the Philadelphia area's plan — they're just two totally different places," Howell, of AHA, said. "So the hope is that we're going to have all of those issues hashed out now."
Fewer than a third of the state plans for vaccine distribution give an estimate of the number of providers in the area eligible to give a vaccine, and few are doing extensive outreach to get providers to register as eligible, according to an analysis by the Kaiser Family Foundation.
Another difficulty is the need to track second doses. The Pfizer and Moderna vaccines require two shots several weeks apart, and others may as well. People will need to be directed to get the second shot, to get the correct vaccine and to get it at the right time.
The coordination required to achieve that is still being determined in many areas. Some state health departments will take up the task. Methods for reminding people to get their follow up dose could include text messaging and phone calls.
That could be complicated if multiple vaccines receive an EUA in a short time period. In that case, tracing includes not just when someone received a dose but also which vaccine they got.
Staffing is another huge concern. Health systems anticipate they will need to increase the number of providers available to administer doses. One estimate from the CDC posits that one provider will be able to give only six shots an hour.
McCurdy said Atrium is estimating its needs based on previous flu immunization campaigns. "We've been looking at that as a model of how we've done those vaccinations and immunization clinics before and what we think it will mean to do that for the coronavirus vaccine," he said.
Staff will also have to be trained on how to unpack, dilute and administer each vaccine that is approved.
And, front-line providers could face difficult tasks such as determining a person's eligibility during tiered distribution. It brings up the question of whether someone who says they have an existing condition that puts them at high risk, for example, has to bring documentation to prove it.
They're not looking at just clinicians either. Hospitals are reviewing security plans for making sure doses are kept under lock and key, as they could be lucrative on the black and gray markets. Facilities are also reviewing how staff can be kept safe if members of the general public turn up at a site demanding to be vaccinated.
"There's a lot of concern around how you crowd control on Day One of being able to offer the vaccine," Saha said. "How do you protect the healthcare workers?"
Hospitals also have to consider contingency planning in case of a natural disaster or other emergency that may cause power outages or similar disruptions. Rural sites that are the only distribution location in a large radius in particular will have to establish backup protocols to keep dosages at the right temperature.
All of these issues are compounded as more doses are manufactured, said Cathy Bennett, CEO of the New Jersey Hospital Association. "I think the problems become more pressing as more and more vaccine becomes available and we start to move through the different distribution levels," she said.
Public health experts say multiple vaccines will be needed for widespread distribution, and having more to choose from will be helpful despite the potential logistical complications. A vaccine like Pfizer's may be sent to more populated areas with the resources to distribute it while others are prioritized for more rural areas, for example. And some may have better efficacy with certain populations, Swann said. "Having a portfolio of vaccines is not a bad thing," she said.
Communicating with surrounding communities
Hospitals have already been playing an outsized role in educating the general public of the dangers of COVID-19 and the best methods for preventing spread. The lack of effort in this area from the Trump administration has left education squarely on the shoulders of clinicians and other public health officials.
Medical organizations have launched ad campaigns to urge people to wear masks, social distance and wash their hands frequently. Soon that communication may include prompting people to get vaccinated.
"We're familiar with this because the flu vaccine conversation comes every year and we spend a lot of energy and time trying to educate the public and healthcare leaders about the importance of getting your flu shot," Howell said. "So we're taking that model and ramping it up here."
Atrium has created a registry for patients and others interested in vaccine work, McCurdy said. "Our intent is to make sure that we try to educate the public about what a vaccine is, how does it come to be marketed in the sense of getting approval."
Polls suggest a broad swath of the U.S. population is skeptical of a quick coronavirus vaccine and will need convincing to receive a shot. Certainly the general public will at least want information on effectiveness for various groups of people and potential side effects.
Many health systems plan to have their own teams review drugmakers' data to do their due diligence and be able to offer the information from a trusted local source and not just federal agencies.
Another key talking point for providers will be the need for community members to continue other efforts to mitigate spread of the virus, such as wearing masks, washing hands, getting tested and staying socially distant. Those will continue to greatly help in managing the pandemic even after a vaccine is approved.
The responsibility doesn't rest only with hospitals and providers. The federal government has a role as well, experts said.
Consistent and scientifically accurate messaging will be more likely under President-elect Joe Biden, whose term begins Jan. 20. Swann said she also expects more public communication and transparency around issue like adverse reactions, vaccination rates and production numbers.
"We need the FDA, we need the CDC both to do their piece which helps with that national messaging," Bennett said. "So from that perspective I think we need the federal government to do what it has always done. And their roles are to help build confidence in a vaccine."