In December 2020, the Food and Drug Administration approved the Pfizer/BioNTech vaccine for emergency use in the U.S., making it the fastest vaccine to be brought to market. Approval of the vaccine has come just 10 months after the first COVID-19 cases were reported in the U.S. A second vaccine, from Moderna, is also expected to gain FDA approval in December.
And so begins a new race against the novel coronavirus: vaccine management and distribution. Using lessons learned from previous public health crises, such as the H1N1 outbreak, state leaders are mapping out how they will inoculate as many people as possible, as safely and effectively as possible.
To help state leaders through this process, the National Governors Association issued a memorandum with basic guidelines. Although the memo doesn’t cover specifics related data interoperability, it is clear that tracking data such as who gets the vaccine, how many doses each person receives, adverse reactions, ineffective batches, and other factors, will be crucial.
As I read the NGA memo, several interoperability-related ideas occurred to me.
What the ‘Push’ and ‘Pull’ Models of Vaccination Mean for Interoperability
“Pull” means that people go somewhere (a pharmacy, a popup location, etc.) to receive the vaccine. This means that interoperability has to reach out to all those corners of the healthcare system, including temporary locations.
This is a new problem, and it’s one we haven’t handled well with regard to COVID testing. However, some innovative healthcare leaders have created solutions to ease the burden. For instance, working with Lyniate’s Professional Services team, Nova Scotia Health Authority helped save its public health team thousands of hours in reporting and investigating contacts with negative results.
“Push” means that healthcare workers are going out to people’s homes, nursing homes, and other locations to administer the vaccine without patients going to a central location. Interopability in this case will mean the healthcare workers have a mobile device to document the activities. Healthcare interoperability with mobile devices as a source and an immunization registry as a destination is also a new pattern for the industry to solve.
In both cases, I imagine there will be patient identification and matching issues to grapple with, on top of just the logistics of routing the messages.
Immunization Data Will Come in Waves
The NGA memo suggests that vaccines will roll out in five waves, with each tier targeting the next riskiest group — starting with frontline workers and ending with healthy adults. This gives us a little bit of good news when it comes to the volume of data.
First of all, we’re not going to get 300 million immunization records all in a single week or month. It’s going roll out over a long time and ramp up as well. Tiers one and two are relatively small; three and four are medium; and five is the largest.
This will give healthcare leaders some time to scale up interoperability capacity and react to the increasing volume. The industry will still have to be able to manage a huge amount of data across a wide variety of sources, but at least the volume is going to evolve in a somewhat controlled way.
Vaccine Distribution Challenges
All that said, I don’t think interop is our biggest problem. There’s a lot of hesitancy around this vaccine. At one end of the spectrum, there are anti-vaxxers, who are against all vaccines. At the other end are people who fear the vaccines are being rushed to the market and don’t trust the safety. Solving this problem should be priority number one.
There are also logistical problems associated with getting the doses distributed globally — often with strict storage requirements. How are we going to do this, and how are we going to know that the medicine was properly handled at each step in the supply chain? Solving this should be priority number two.
And as people receive the vaccine, another challenge we’ll have to solve is, how do we share data with employers and schools? At the heart of this is ingesting and sharing data among disparate systems, which will require an understanding and normalization of different types of data.
The good news is that the elements of interoperability exist and the challenge is in scaling them. Health systems are integrating clinical data. Health Information Exchanges allow different types of healthcare organizations to share data outside their own walls. Labs share data with public health agencies. And public health agencies share data with the CDC.
We’ve seen innovators come together to create new vaccines in record time. It will be interesting to watch how we evolve to integrate clinical data and public health data during the vaccine rollout to track vaccine efficacy, get people back to work, open our world economies again, and keep us all healthy.