Wednesday, February 3, 2021

Fixing the Vaccine Rollout

 In this go-go era of Twitter and 24 hour cable news channels, things that happened a few days ago are old news and things that happened a few months ago are ancient history.  So the healthcare.gov fiasco from 2013 counts as prehistory.  BTW, the word "history" has a precise definition.  It consists of the body of events that happened at a time and in a place where someone wrote down an account of them.  Everything else is prehistory.  In spite of the fact that it happened so long ago that it is effectively prehistoric, that particular fiasco bears on the current subject.

And, since I am talking about a prehistoric event, let me review the details.  President Obama spent most of his first two years in office passing healthcare reform.  The final law that was enacted is informally called Obamacare.  The official title is the Affordable Care Act, or ACA, for short.  Components of the ACA rolled out in phases.  One of those phases included a web site  that anyone could use to find an "individual" health care plan.  It didn't matter which state you lived in, healthcare.gov was supposed to steer you to a plan that was available in your area.

The web site went live on October 1, 2013 and promptly crashed.  And crashed.  And crashed.  Soon, many people who should have known what they were talking about, started saying, "it's broken and can't be fixed."  President Obama didn't panic.  Instead he brought in a group of very experienced executives from the tech industry to put it back on track.

They succeeded.  And it only took them 60 days.  I wrote a blog post on how it all went down.  You can find it here:  Sigma 5: Fixing healthcare.gov.  It's a good read.  And my thesis for this post is that there are a lot of parallels between that situation and the one currently surrounding the rollout of the COVID-19 vaccine.  Let's start with a quick review of what went down back then.

The people who were brought in had a tremendous amount of experience managing complex IT projects.  They looked the situation over and decided that the fundamental architecture was fine.  That was good news because architecture issues are difficult and time consuming to fix.  What they did find were a lot of easier to fix problems.  Unfortunately, it would be necessary to fix pretty much all of them before the site would work.

That's because there were a lot of components involved.  Many of them were broken.  Many components also did not play nice with other components.  And a big problem was that the system had to interface with 50 different state systems.  Each had its individual quirks and peculiarities.  But the new team didn't panic.  Instead, they did what good project managers always do.  They created a "punch list".

The idea comes from the construction industry.  You take a tour of the project and look for everything that needs attention.  Each item is a "punch" on the list.  As each item is put right it is "punched" out of the list.  Ideally, you eventually end up with a punch list containing no items.

So the team built a punch list.  Then they prioritized it.  Then they sent out the top priority items to the various contractors working on the project with instructions to fix them.  Then they kept track of the results.  Once these top priority items were fixed they looked at the list and picked out a new set of top priorities and sent it out.  It really was as simple as that.

There are several things that helped.  These people knew what they were doing so they built a good punch list.  The contractors, who it turned out were actually doing good work, knew that these people would not accept second rate work so they set to and started fixing problems.  And the managers were careful to keep their priority list as stable as possible,

You always need to be prepared to change things up as the situation evolves.  But I have spent a lot of time in IT.  And I have frequently found myself in situations where the priority list gets completely rewritten every few days.  It takes time and focus to fix a problem.  You don't get much productive work done by switching from project to project to project all the time without staying on one project long enough to finish it.

The management team also did a lot of communication.  It was important that all the players knew what was going on.  These players included the White House, the various contractors, and each state.  It was particularly important to work individually with each state.

The idiosyncrasies of its particular systems and way of doing business, were different for each state.  But a solution that worked both for the overall system and for each state had to be implemented for the overall project to be a success.

That required a lot of communication and a considerable amount of flexibility.  But the states soon found that they had a partner that was willing to listen to them and to work with them, so it all got ironed out.

For a couple of weeks nothing appeared to be happening.  The site still kept crashing.  Pretty much none of it seemed to be working.  But that was because a lot of things had to be fixed before any change would be apparent to outsiders.

In reality things were being fixed on a daily basis.  But until lots of components were working, and working together, all that was happening was that the point of failure was just being moved around.  But then enough things got fixed that some parts started working.  Then more things got fixed and more parts started working.  And, in a surprisingly short amount of time, it was all working.

The bottom line was that the Obama people really had done a pretty good job.  They just weren't skilled enough or experienced enough to pull a project of that complexity and difficulty off on the required timeline.  With the knowledge and steadying hand provided by the outside experts things came together quickly.  And the good work the Obama people had done in laying a sound foundation made that possible.

Health care is complicated.  Health insurance is complicated.  Tracking a single item, or in this case, a few similar items, is a piece of cake in comparison.  So the fundamental problem presented by the vaccine rollout is much simpler.  But structurally, it has similarities.  This Federal system has to glue everything together.  And it has to deal with the idiosyncrasies of 50 different states.

There is one key difference.  The Obama people believed in doing a good job.  And they felt that what they were doing was an appropriate role for the Federal Government to fulfill.  The Trump people, on the other hand, really didn't believe in government.  So, they doubted that what they were supposed to do was even an appropriate function for the Federal Government to perform.

Assuming the job needed to be done at all, then they were of the opinion that somebody else should do it.  They really don't care if it was the States or private businesses.  Just so long as it is not the Trump Administration.  But it was important to maintain appearances in order to fend off criticism.  So, they put together a system that was more designed to fend off criticism than it was to work well.

As a result, when the Biden people came aboard they found little to work with.  Their standards were completely different.  They expected the system to actually be capable of doing the job, not just pretending to do it.

And a big part of that was providing a system that State Governors, both Democratic and Republican, could make work in their various states.  While the Trump people were in charge Governors found that they did not have a reliable partner at the Federal level to work with.

To pick one well publicized example, a key question is how much vaccine will each State get and when will they get it.  According to lots of public proclamations by various Trump officials the answers were "a lot" and "right away".  But when State officials queried their Federal counterparts they quickly learned that neither was true.

First, the figures put out publicly describing how many doses each State would get were far higher than the actual amount that was later officially promised and still later delivered to each state.  Second, they only learned how much vaccine they would be receiving late in the week before the vaccine would be arriving.

So, states were expected to get by with less.  And they couldn't plan ahead because they didn't know how much vaccine they would be receiving, two, three, or four weeks out.  That made it very hard for them to plan for the efficient distribution and administration of the vaccine they did receive.  It also led to hoarding.  If you don't know how much you are getting, then it seems like a good idea to hold back a lot of what you already have, "just in case".

But it turned out that the problems didn't end there.  Getting doses out of freezers and into arms turned out to be much harder than most predicted.  And it was not just the super-cold freezers that were required.  A key group that everybody prioritized were elderly people living in congregate care facilities.  

These people have a lot of physical and mental issues.  Many of them are bed ridden.  Many of them get confused or upset easily.  You have to go to where they are and you have to provide a lot of extra TLC.  The result was that for this group the amount of time it took to do one injection was about twice as long as forecast.

Plans for tight grouping and tiering also quickly broke down.  The "use it or lose it" characteristic (doses must be used within 6 hours of being "reconstituted") meant that careful plans must be made or many doses would be wasted.  Who was supposed to do this careful planning?  Overloaded and over-stressed State Health Departments and pharmacy chains like CVS and Walgreens.  What could possibly go wrong?

The situation that the incoming Biden team inherited was chaotic and underperforming everyone's expectations.  But the underlying problems were not that complex.  Can vaccine manufactures accurately forecast their production rates?  The answer seems to be "yes".  That's the foundation underlying everything else.

As is typical, the Federal Government is actually doing very little itself.  Others "do" while the Federal Government directs and tracks.  Companies like Pfizer and Mederna manufacture the vaccine.  Companies like FedEx, and UPS ship it.

It gets more complicated than that as we move vaccine doses closer and closer to people's arms.  But it is still a situation where this company or department performs a certain function.  The vaccine needs to be tracked as it moves down the chain.  Then patient information needs to move back up the chain so that we can track what's going on.

One current problem seems to be that long, elaborate, forms need to be filled out for each injection.  That's because in the early going health insurance companies and health care providers, the people who have the information the forms demand, were cut out of the loop.  That is starting to change.

I, for instance, am getting my vaccinations through my regular health care provider.  It already has all the information the forms require in it's computer system.  I know others who have been able to work through their health care provider to schedule and receive their shots too.  That doesn't work for everyone.  But it works for most people.

We all know that the data is going to eventually end up in a compute somewhere.  Any data on a paper forms will have to be keyed in at some point.  So why not do a computer-to-computer transfer in the first place?  It's faster, cheaper, and more accurate.

Things are getting ironed out.  Some of this "ironing out" actually began before Trump left office.  But I expect things to accelerate.  Coordinating vaccine distribution is the easy part.  Compared to getting the healthcare.gov web site working. it is a trivial undertaking.

And collecting and reporting vaccination statistics accurately. and in a timely manner, is also not very complicated.  I expect all of these problems to be ironed out by the end of February.

Getting the vaccine to the states is already working pretty well.  Getting it from there to people's arms is a much more difficult problem.  We have seen progress in this area but much more needs to be done.  Only about 60% of shipped doses have been used, according to the most current CDC statistics.  On the other hand, people have had horrendous experiences trying to finding and schedule an appointment.

One big contributing factor is that demand current vastly outstrips supply.  There is no healthcare.gov one stop web site, for instance.  But the time has passed when it would make sense to create one.  But lots can be done that does not involve a federal web site.

The first thing the Federal government can do is to help states defray the cost.  There is money in the pipeline for this.  And more is coming if the Democratic "COVID" bill is enacted into law.  Even the Republican alternative contains additional funds to help the states with this.

But the federal government can also help with advice and various kinds of technical assistance.  With healthcare.gov, the Federal government went so far as to build the state piece for the states that wanted them too.  Many states took the Federal government up on the offer.  That's not possible in this situation.  But there is a lot the federal government can do to help.  One way or another, I expect this problem to be largely solved by the end of March.

That leaves the biggest problem of all, vaccine availability.  This is totally a Federal responsibility.  And it is the one that will take the longest to solve.  Vaccine makers know that they can sell everything they can make.  So they are making all they can already.

The Federal government can use the Defense Production Act to help the companies out.  While there's nothing that can be done immediately, there is lots that can be done over time.  Ramping up production can only be done so fast, no matter what you throw at the problem.  But the government can be very helpful down the line.

The amount of vaccine that will be produces is pretty much baked in for the next few months.  Production should increase substantially in second quarter (April-June).  It can continue to increase in subsequent quarters.  I expect that supply will be pretty much in alignment with demand by the Fourth of July.  If we are lucky, we will be able to reach that goal by Memorial Day.

That should mean that everybody in the U.S. can get vaccinated before the Summer is over.  And it looks like the same will be true for Europe.  But the combined population of the U.S. and Europe constitutes only about 10% of the population of the world.  And it is the richest and most heavily resourced 10%.  This pandemic will not be under control until the world is vaccinated.  

The vaccines in use in the U.S. are expensive and hard to administer.  They are not the right tools for use in most of the world.  We need vaccines that are equally effective but much cheaper and easier to use.  There are some candidates.  But effectiveness is still a question.  As is cost.  And current world vaccine manufacturing capacity is woefully inadequate.

So, it looks like it will be 2022 or 2023 before the world is shot of this scourge.  And that's a big problem for all of us.  Variants are now popping up all over the place.  Currently the variant of most concern is one that was first identified in South Africa.  All of the vaccine candidates that have been tested against it show substantially reduced effectiveness.

So all is lost, right?  Actually, no.  First, current vaccines are very effective at keeping people out of hospital and, more importantly, at keeping them from dying.  The data currently available indicates that this is true even when the new variants are involved.  Secondly, vaccines can be tweaked.

Many of the vaccines and candidates are based on new technology.  Both the Pfizer and the Moderna vaccines are "mRNA" technology.  As such, they needed to be subjected to more scrutiny that would have been appropriate for a vaccine candidate that worked the old fashioned way.

We are now field testing these new approaches by injecting these vaccines into a lot of people, including me.  If, as expected, vaccines based on mRNA and other new technologies turn out to be safe and effective, then the technologies they are based on become not "new" but "proven".  Heightened scrutiny will no longer be appropriate.

A vaccine needs to be targeted.  One of the big advantages of these new vaccine technologies is that they can be targeted more precisely and more quickly than vaccines based on old technologies.  Vaccine makers that use new technology say that they can quickly and easily retune their vaccines to improve their effectiveness against the variants that are now popping up.

The approval process should take far less time once the basic approach has been proven out.  That means that vaccine makers think they can turn out "new and improved" versions of their vaccines within a few months.  And I believe them.

There is already talk that people like me, who will soon have competed the current process, may need a "booster" in six months to a year.  "New and improved" vaccines that are highly effective against the new strains, and the capacity to produce them at scale, should be ready by then.

I don't know whether this optimistic forecast will apply to the less wealthy parts of the world.  Work is moving forward on vaccines that are effective but also are cheap to make and easy to administer.  They just aren't ready yet.  When they do become available, some of their characteristics will be critical.

I'm not talking about the necessary attributes of being cheap and easy to administer.  I am talking about other attributes.  Will they come pre-tuned for the new variants?  Will they be easy to retune?  Will periodic booster shots be required?

This last attribute may be the whole game.  Periodically administering booster shots in the U.S. and Europe is relatively easy to pull off.  Having to periodically administer boosters to the entire world looks to be neigh on impossible.

There's hope.  But we are still a long way from being out of the woods on this one.

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