Medically Necessary: IT systems slow vaccine rollout, new vaccines add complications
Medically Necessary: IT systems slow vaccine rollout, new vaccines add complications
Good Afternoon. Medically Necessary is a newsletter about the health care supply chain, how we get drugs, devices and medical supplies to health care providers and patients.
Convoluted IT systems slowing vaccine rollout
The problem: The process for sharing data about COVID-19 vaccine distribution is a convoluted Rube Goldberg machine and it’s slowing down the vaccine campaign.
The background: The Centers for Disease Control and Prevention lists six different software systems used to track vaccine administration and distribution.
- States also have their own immunization information systems, existing programs that track all types of vaccination records for individuals.
- A national system for ordering publicly funded vaccines, called VTrckS, was launched in 2010. States are now using it to order COVID-19 vaccines.
- Earlier this year, the federal government tapped Deloitte to build software for managing vaccine administration across the U.S. Many vaccine administration sites are choosing alternatives because the system was plagued with problems.
Where are we now? In some cases public health officials must manually download data from one system and upload it into the next, according to a detailed story about the data management process in MIT Technology Review.
- The Tennessee Department of Health is using its immunization registry — called TennIIS— instead of Deloitte’s Vaccine Administration Management System because the platform was still under development as the state was planning its vaccine distribution strategy.
- “Information recorded to TennIIS is transmitted to the CDC. TennIIS does not, however, communicate with Tiberius, which is the tool provided by CDC to plan vaccine allocations,” health department spokesperson Bill Christian wrote in an email. “This means allocations are planned in Tiberius, then downloaded and manually entered into TennIIS, then downloaded and uploaded to the VTrckS system to place the orders.”
A solution: Rob Handfield, the executive director of the Supply Chain Resource Cooperative at North Carolina State University, said it would make more sense to have a single, national system that allows states, vaccines sites and the federal government to communicate with each other about their inventories and needs. Without that kind of communication, the vaccine distribution project is blind, he says.
- “Running a supply chain without data is like driving your car down the street without a speedometer or a GPS,” he told FreightWaves. “That’s what it feels like they’re doing. They really aren’t tracking what’s going on.”
In a recent blog post, Handfield presented India as a counter example. The country is planning to use a single application to manage its vaccine campaign, but the app isn’t available to the general public so it’s still unclear if it will work.
We’ve been here before: The Childhood Immunization Initiative Act of 1993 was supposed to create a national immunization registry, but instead funding went to registries for individual states. According to the American Immunization Registry Association, needs varied widely from state to state and it was difficult to create a system that satisfied everyone.
Bill Brand, the director of public health informatics strategy at the Public Health Informatics Institute, said a nationwide IT system for managing COVID-19 vaccine distribution would be more efficient. But creating that system would have faced the same regulatory and cultural challenges as the national immunization registry.
- “Certainly the technology exists to do this. If we were a different kind of country we would have single nationwide IT systems for all this kind of stuff. But in fact we were intentionally set up to be very federated,” he told FreightWaves. “Generally speaking in America we’re willing to accept some of that inefficiency and frustration for the sake of maintaining local control.”
What comes next? Now, two months into the vaccine rollout, Brand says the U.S. government should focus on improving the current system, rather than building something new.
- “Switching horses mid-race is pretty disruptive to everybody,” he said.
States are getting better at using the current Rube-Goberberg-like system. The rate of vaccinations in the U.S. has increased steadily since mid-December and the federal government is taking steps — such as doling out vaccines in pharmacies and invoking the Defense Production Act — to speed it up further.
The American Immunization Registry Association doesn’t see a nationalized IT system for immunizations on the horizon, but Brand said public health officials are learning from this pandemic and will come out strong. Let’s hope they’re up to the task before the next one.
More vaccine approvals mean more doses but also more complexity
Johnson & Johnson’s vaccine candidate. (Credit: Johnson & Johnson)
Good news: In early February, Johnson & Johnson asked the U.S. Food and Drug Administration to approve its COVID-19 vaccine for emergency use.
- The Biden administration expects the FDA will receive similar applications from AstraZeneca and Novavax in March.
If approved, those new vaccines would be a major bump to the total vaccine supply. In an interview on CNBC, Johnson & Johnson CEO Alex Gorsky said the company is on track to deliver 100 million doses to the U.S. by the end of June. Novavax has also agreed to supply the U.S. with 100 million doses.
The challenge: In some ways, adding new vaccines with different storage and transportation specifications makes the supply chain more complex.
- “It does increase the complexity, which is an inherent risk,” Mark Sawicki, the chief scientific officer of the cold chain logistics company Cryoport Inc., told FreightWaves. “But it does also allow the preexisting capacity to be utilized for these other temperature ranges and takes off some of the pressure for (ultra-cold) storage, distribution and packaging.”
Peter Guinto, who served on the U.S. Air Force COVID-19 task force, said adding new vaccines could increase the risk that vaccine sites receive shipments of a second dose from the wrong manufacturer.
- “Three weeks in a row: Pfizer. And then in week four a shipment of Moderna when the people in the first week are coming for their Pfizer shot. Now they’re going to have to scramble and find another place to schedule,” Guinto told FreightWaves. “Just imagine if that dose, instead of Pfizer, the next week after that was Johnson & Johnson.”
The human element: The upcoming vaccines appear to be effective at protecting recipients from death and hospitalization, but they aren’t as effective at preventing COVID-19 entirely.
- The mRNA vaccines made by Pfizer and Moderna were both about 95% effective at preventing COVID-19, compared to 66% for the Johnson & Johnson vaccine. Numbers for AstraZeneca and Novavax are promising but less straightforward.
Daniel Finkenstadt, a researcher at the Naval Postgraduate School who has worked on COVID-19 supply chain issues for the last year, said that could introduce a new problem. (Finkenstadt’s views are his personal opinion and don’t represent the views of the U.S. military, the Naval Postgraduate School or the federal government.)
- “You have to ask yourself what happens when people … are saying this one is 95% effective and this one is 67% effective, why am I getting the 67%?” he told FreightWaves. “That becomes a problem. Who gets to choose who gets the better vaccine?”
The question is especially important because the Johnson & Johnson, Novavax and AstraZeneca vaccines can be transported and stored at higher temperatures, which could affect who receives them. If patients turn up their noses at the new vaccines, it could change the pattern of vaccine distribution.
- Some states, such as Tennessee and Arkansas, are already sending the Moderna vaccine to rural areas and small towns because, compared to Pfizer’s shot, it’s easier to meet the refrigeration requirements and comes in smaller boxes.
Bottom line: More vaccines will speed up distribution. But it’s the human element that will be the trickiest to manage.
- “It becomes a marketing and communications issue in addition to a supply chain issue,” Finkenstadt said.
Shipping vaccines to pharmacies should accelerate vaccinations
The U.S. government has started delivering COVID-19 vaccines to retail pharmacies. (Credit: CVS)
More good news. Retail pharmacies like CVS and Walgreens, as well as independent pharmacies, started giving out COVID-19 vaccines across the U.S. last week. The Federal Retail Pharmacy Program is a big opportunity for the U.S. government to reach more people.
The first step was shipping 1 million vaccine doses to 6,500 pharmacies. The program could eventually include up to 40,000 pharmacies once the vaccine supply is steadier.
The potential: Eugene Schneller, a health care supply chain researcher at Arizona State University, said he believes that distributing vaccines from pharmacies will speed things up because so many people live close to pharmacies.
- “We need to get vaccine to where they are, not to where we think they should go,” Schneller told FreightWaves.
The first misstep: Bloomberg reported that Walgreens’ vaccine scheduler crashed as people rushed to make appointments. The website eventually recovered.
Scaling up: In preparation for the massive increase in vaccinations, The New York Times reported that pharmacies have been feverishly hiring pharmacists and pharmacy technicians to administer vaccines.
- CVS has already hired more than 15,000 pharmacists, its original goal. Walgreens has hired about 7,500 and is aiming for 9,000, according to The New York Times.
According to a recent report from STAT, the massive project is taking a toll on pharmacists. They’re struggling to prop up scheduling software and phone lines that are pushed to the limit and putting in long hours to help patients anxious to get a vaccine.
Wishful thinking: One wish to improve COVID-19 vaccine rollout
Wishful thinking is a section of the newsletter where I give experts one wish to improve the health care supply chain. Send your wishes to email@example.com.
“Quickly follow the polio model. … Move from injection (1955) to oral (1961). Solves lots of problems – and allows many to be inoculated quickly.”
— Eugene Schneller, health care supply chain researcher at Arizona State
- Jonas Salk created the first effective polio vaccine in 1955. It was an injection, and at first supplies were limited.
- In the early 1960s Albert Sabin developed an oral polio vaccine. The new vaccine, which required just two drops, was much easier to administer.
The hope: In one fell swoop, an oral COVID-19 vaccine would eliminate cold-chain concerns and vastly speed up and simplify the process of giving someone a vaccine.
The real deal? A California company called Vaxart is trying to produce an oral COVID-19 vaccine.
- An investor presentation promises a pill, stable at room temperature, that will end the pandemic with “no appointments, no lines … no cold chain, no needles or devices, no waste.”
Not yet: The technology for this oral COVID-19 vaccine is far from a sure bet. A small preliminary study found that the tablet caused an immune response but didn’t produce neutralizing antibodies, an important signal of efficacy. The company’s stock plunged after reporting the results.
Lesson learned: Salk’s polio injection helped curb the epidemic in the U.S. quickly, but it took decades to reduce polio cases worldwide. The oral polio vaccine continues to be an important tool in the fight against the disease.
Even if it takes years to develop, maybe a COVID-19 vaccine tablet will help keep the virus in check across the globe after injections have tamped down the largest outbreaks.
Reading list: The best stories about the health care supply chain
- Why some hospitals have to scramble for oxygen to treat Covid-19 patients — STAT
- This is how America gets its vaccines — MIT Technology Review
- Medical Drone Startup to Begin Covid Vaccine Delivery in April — Bloomberg
- Covid-19 vaccination rates follow the money in states with the biggest wealth gaps, analysis shows — STAT
16 February 2021, 23:30