vaccines – The OM Blog by Heizer, Render, & Munson

OM in the News: The Wasted Vaccines

As demand for COVID-19 vaccines collapses in many areas of the U.S., states are scrambling to use stockpiles of doses before they expire and have to be added to the millions that have already gone to waste. “It’s sad to say I’m in the process of throwing 30 million doses in the garbage because nobody wants them. We have a big demand problem,” says Moderna’s CEO in the Washington Examiner (May 26, 2022)

Germany may discard 3 million COVID-19 vials

Nearly 1.5 million doses in Michigan, 1.45 million in North Carolina, 1 million in Illinois, and almost 725,000 doses in Washington couldn’t be used. The national rate of wasted doses is about 9.5% of the more than 687 million doses that have been delivered. That equates to about 65 million doses.

The problem is not unique to the U.S. More than a million doses of the Russian Sputnik vaccine expired this week in Guatemala, because nobody wanted to take the shot. The pandemic has killed nearly 6 million people and shattered economies across the globe, and every dose that goes to waste feels like a potentially missed opportunity in preventing serious disease.

It also comes only about a year after people desperate to get the vaccine attempted to jump in line to get ahead of those deemed higher priority. Hospital board members donors around the U.S. got early access or offers for vaccinations, raising complaints about favoritism and inequity at a time when the developing world had virtually no doses.

And many poorer nations still have low vaccine rates, including 13 countries in Africa with less than 5% of their population fully vaccinated. They are plagued by unpredictable deliveries, weak health care systems, vaccine hesitancy and some supply issues. Redistributing states’ excess doses to other nations is not feasible because of the difficulty in transporting the shots, which must remain cold, in addition to not being cost effective because of the relatively small number concentrated at sites.

With demand so low, states will undoubtedly be confronted with more waste in the months ahead. Idaho, for example, has 230,000 doses on hand but is only averaging fewer than 2,000 doses administered a week. West Virginia has offered to transfer Pfizer adult doses to nearby states. States are ordering prudently, paralleling the drop in demand. The minimum order for Pfizer used to be nearly 1,200 doses but now it’s 100.

Classroom discussion questions:
1. Why does the EOQ inventory model described in Chapter 12 of your Heizer/Render/Munson text not work well for this item?

2. What forecasting models in Chapter 4 could be used to predict demand for the shots?

OM in the News: Making Vaccine Bottles

Combating the Covid-19 pandemic is at the top of the global agenda. Providing vaccines to populations around the globe means providing 8 billion doses—with only one for every person in the world. In addition to the availability of the vaccine, a decisive factor in the race against time is the accessibility of the glass vials. Producers of the vials are massively ramping up their production so as not to become the proverbial bottleneck in the supply chain, reports New Equipment Digest (April 6, 2021).

vaccine

However, medical-grade vaccine vials are not standard glass tubes. They are all made of the special glass borosilicate and require customized production lines. For example, the glass must be resistant to a wide range of chemicals and temperature changes and must not contaminate medicines. Any interaction between the container and the liquid inside must be prevented, as any chemical interference could affect the vaccine. Even the smallest scratch, crack or fissure can render an entire batch unusable, contaminate the line during the filling process or even lead to a machine standstill.

The demands on manufacturers are enormous: it is not only a matter of producing large quantities quickly but also of maintaining particularly high-quality standards. So what is needed is very fast quality control with high reliability in defect detection. One solution is vision systems, our topic on page 296 in Chapter 7. Powerful cameras can capture images of 120 vials per minute to be inspected for dimensional accuracy or surface condition with very high precision. Defects such as cracks, scratches, chips, inclusions or stains are detected with an accuracy of 0.1 square millimeters. Intelligent software enables accurate fault description analysis and classification. Testing takes place at various points in the manufacturing process, such as directly after the bottles have been formed or shortly before packaging.

Classroom discussion questions:

What are vision systems and why are they a useful OM tool?
Which of the quality control tools in Chapter 6 (Figure 6.6) of your Heizer/Render/Munson text could vial producers employ?

OM in the News: Vaccine Manufacturing in U.S. Races Ahead

Covid-19 vaccine manufacturers are ramping up production, churning out far more doses a week than earlier in the year, progress that is accelerating mass vaccination campaigns in the U.S., writes The Wall Street Journal (March 22, 2021). This is good news and is a followup to our blog (March 21, 2021) how making Covid vaccines is taking away from production of other important drugs. This is a nice place to introduce Figure 7.1 (the four process strategies) to your students.

After a slow start, Pfizer and Moderna have raised output by gaining experience, scaling up production lines and taking other steps like making certain raw materials on their own. Pfizer figured out how to stretch scarce supplies of special filters needed for the vaccine production process by recycling them. (The filters remove certain components from the vaccine during production.) And the company added more high-speed vial-filling lines to its plants.

pfizer2

Moderna took 3 months to make the first 20 million doses of its vaccine last year, but now it is making roughly 40 million a month for the U.S. The U.S. monthly output for the authorized vaccines is expected to reach 132 million doses for March, nearly triple the 48 million in February.

Moderna wasn’t able to produce at maximum capacity right out of the gate because of the need to introduce new equipment and processes in stages. It was still training newly hired workers and encountering issues like equipment malfunctions and holdups in getting replacement parts such as filters. It is planning to further speed output by boosting the number of doses in each vial to 15 from 10. “There has not been a single week since we started that we have not had issues,” said a company exec.

Some 2.5 million people in the U.S. are vaccinated daily on average, up from about 500,000 in early January. The increased output should be enough to fully vaccinate 76 million people in the U.S. in March, 75 million in April, and 89 million more in May.

Classroom discussion questions:

Which process in Figure 7.1 of your Heizer/Render/Munson text best fits the vaccine manufacture?
What factors had made the vaccine so difficult to produce?

OM in the News: Rival Drugmakers Form Alliances

Some of the world’s biggest drugmakers are joining forces with rivals to help produce Covid-19 vaccines, forging unusual alliances that promise to substantially increase supplies by this summer. As we write in Chapter 5, Design of Goods and Services, alliances are a good strategy “when substantial resources are required and sizable risk is present.”

Normally big pharm companies compete to sell cancer, arthritis and other drugs. The desperate need for Covid-19 vaccines, however, is turning fierce industry competitors into fast pandemic friends. Sanofi SA recently agreed to help make a vaccine from Pfizer after Sanofi’s experimental Covid-19 shot suffered a 5-month setback, freeing up a production line in Frankfurt. Novartis AG also agreed to hep Pfizer produce more doses.

Endo International has agreed to help Novavax produce its shot.

The collaborations, along with the authorization of newer vaccines and fine-tuning by the vaccine makers themselves, could help significantly boost global output, reports The Wall Street Journal (Feb. 24, 2021). Early supplies have been limited, as vaccine makers needed time to increase production and overcome early hiccups and problems getting raw materials.

The production alliances are the latest example of industry rivals coming together to fight the pandemic, starting with research tie-ups. They build upon a year-long effort by the drug industry and partners to crank up capabilities to make everything from the tiny vials that hold the shots to raw ingredients that make them. But production can’t start overnight. Vaccine manufacturing is a complex process that often requires training staff, upgrading facilities and buying new equipment.

Novavax, which has a vaccine in the late stages of development, doesn’t own a manufacturing plant and has to lean on other companies to produce the shot. Baxter said one of its plants in Germany will help fill and finish Novavax’s vaccine, as did Endo in Rochester, Michigan–under pressure from the U.S. government.

Classroom discussion questions:

What will happen to these alliances once the pandemic is under control?
Why is it challenging to produce the new vaccines for another company?

OM in the News: Why the Europeans are Not Vaccinated

As Western governments faced criticism for their pandemic management last summer, EU officials began work on a vaccine-procurement plan they hoped would put the continent at the forefront of efforts to banish the coronavirus and reopen economies, writes The Wall Street Journal (Feb. 3, 2021). Instead of its 27 member states fighting for doses from a few manufacturers, the EU would centralize purchases for 450 million inhabitants, bringing prices down and ensuring that residents of rich and poor countries alike would get equal access to the best shots available.

Half a year later, an acute shortage of doses is keeping the EU’s vaccination effort from taking off, making it likely that only a small portion of the general public will get a shot by the end of summer. The reasons: The EU was late in ordering vaccines compared with the U.S. and the U.K.; it bet on companies that have yet to deliver; and when delays started creeping in, it blamed the manufacturers instead of restarting negotiations.

A vaccination center in Hannover, Germany

Israel has vaccinated 55% of its population, the U.K. 14% and the U.S. 9%, against under 3% for the EU. While other governments were wooing vaccine makers with subsidies and immunity from liability in case of side effects, the EU focused on pushing prices down and slowing negotiations, which resulted in late orders. It also spread its purchases widely to reduce risk, signing deals with companies that are still months away from approved shots. And it was slow to authorize the vaccines it had purchased.

In January, the makers of all vaccines approved for use in the EU (Pfizer/BioNTech, Moderna, and AstraZeneca) announced cuts in deliveries because of manufacturing bottlenecks, forcing governments to slow or pause vaccinations. Yet given how complex vaccine manufacturing is, early bookers are less likely to get hit if manufacturing problems appear as production ramps up.

Classroom discussion questions:

What are the cultural differences in vaccine acceptance in various countries?
What are the manufacturing complications that are slowing production of vaccine shots?

Teaching Tip: The Vaccination Assembly Line

The Orange County Convention Center, here in Orlando, is a massive and magnificent building. At 7 million square feet (something like 146 football fields over 22 acres), it is the second largest facility of its kind in the U.S. The main exhibit hall alone seats 139, 857 people, enough to easily handle conventions such as MegaCon (68,940 in attendance), NCAA Volleyball Championships (72,000), and Design Week (85,000). But during COVID, the Center has largely sat empty, as tourism and its 125,000 related jobs in Orlando have declined dramatically.

But alas. The Convention Center has a new purpose. Its underground unloading area has been turned into a COVID-19 vaccination drive-thru assembly line! Here is an interesting example of a service assembly line (Ch.9) and a multichannel, multiphase queuing system (Module D) that you can share with your students. I just went through the system this week and was impressed by the operations planning and execution.

Work Station 1: Outside the building, a single channel queue greets you, with the server checking the bar code on your cell phone to be sure you are eligible to enter.

Work Station 2: Inside the building, the medical team scans your barcode again, takes your temperature, and attaches a barcode sticker to your arm. You drive forward 10 yards.

Work Station 3: Your arm barcode sticker is scanned and you are asked a series of medical questions. The brand of shot you will receive is announced (no choice) and you are provided informational material. You drive forward 10 yards to parallel Bays A, B, or C as directed.

Work Station 4: Your arm barcode is scanned again, you get the shot, with band aid applied. You are told to exit the building and wait in your car in the adjacent lot to see if there is a negative side effect. You are to honk your horn if you are ill.

Work Station 5: You sit in the lot for 15 minutes.

Work Station 6: You are scanned again as you exit the property and asked if you had any side effects. You never leave your car.

Total time in system, including 15 minutes in parking lot, is 25 minutes.

Classroom discussion questions:

Clearly the system is efficient, but can it be made more so?

2. Can it be easily replicated in every city?

OM in the News: The Last Vaccine Mile is a Long One

The U.K. became the first Western nation to start immunizing its residents from the coronavirus this week. But the speed of authorization and implementation of the program are being tempered by the reality of getting the delicate Pfizer – BioNTech vaccine to the most vulnerable, reports The Wall Street Journal (Dec,11. 2020).

Reaching the housebound and those in nursing homes is a challenge that offers a cautionary tale for U.S. health officials as they contemplate their own rollout. The main reason is that the conditions needed for the vaccine’s storage aren’t usually found in long-term care facilities. The vaccine must be kept at temperatures of minus 94 degrees Fahrenheit and once thawed, used within 2 hours if at room temperature–certainly a Chapter 11 logistics management problem if there ever was one. Another challenge is that the vials holding the vaccine come in packs of 975 and must all be used once opened—nursing home providers say no elderly-care residence exists in the U.K. with so many residents.

Michael Tibbs, 99, was given the Covid-19 vaccine Dec. 8th in Portsmouth, England.

The vaccine must be turned upside down—but not shaken— and returned to resting before it is given. The delicate technology it contains, named messenger RNA, is so new that Pfizer is still running stability studies to work out whether it can be stored for longer periods at warmer temperatures. The clock starts ticking as soon as they thaw the vials and they have 12 hours to complete the pack down, label the boxes and then get the vials to the mobile teams and into care homes.

Distributing a biological product, which requires kid-glove treatment, to the hardest-to-reach corners of Britain has “very significant logistical challenges,” said a government minister.

Classroom discussion questions:

A few OM issues are discussed in this WSJ article. Identify other major distribution problems we are sure to face.
What can governments and/or citizens do to assist in implementing/administering the vaccine?

OM in the News: Protecting Covid-19 Vaccines from Theft

Health authorities, hospitals and pharmaceutical companies are storing Covid-19 vaccines in secure, undisclosed locations and taking other steps to protect the shots against a looming threat: theft.

As the leading vaccine candidates advance closer to use, vaccine makers such as Pfizer are deploying GPS software for tracking distribution and plotting fake shipments in dummy trucks to confuse criminals. Glassmaker Corning is equipping vials with black-light verification to curb counterfeiting. And some hospitals expected to be among the first vaccination sites are beefing up their pharmacies’ security systems.

Initial vaccine supplies are expected to be limited, with some shots gaining authorization as early as November.

The goal is protecting the shots against professional thieves who have a long history of targeting valuable medicines, and have pilfered Covid-19 tests, masks and other personal protective equipment during the coronavirus pandemic, reports The Wall Street Journal (Oct. 22, 2020).

The government has arranged for U.S. marshals to accompany shipments of vaccines, which are currently stored at undisclosed locations, once the shots are authorized for distribution. Despite such measures, logistics specialists worry the shots could be vulnerable to theft at weak links in the supply chain, such as distribution centers, truck stops and hospitals with lax security.

Though drugmakers have been producing doses, initial supplies are expected to be limited, making any shot a coveted commodity. Industry experts are concerned they could be intercepted by sophisticated criminals, foreign governments or individuals eager to get vaccines before prioritized groups. Over the past 5 years, world-wide incidents such as theft and counterfeiting of pharmaceutical products rose nearly 70%.

Classroom discussion questions:

Why will this vaccine’s distribution be a significant challenge?
Table 11.3 in your Heizer/Render/Munson text provides a list of 10 supply chain risks. Which apply in this case? How?

OM in the News: The Challenge of Delivering Covid-19 Vaccines

UPS is combining multiple refrigerators at its airport hubs to store vaccines in transit.

Just 2 weeks ago, Prof. Jeff Heyl delivered his Guest Post from New Zealand saying 8,000 fully laden Boeing 747’s would be needed to deliver a single dose of a Covid-19 vaccine to the world’s population. The Wall Street Journal (Oct. 6, 2020) asks: “If just 50 million doses were available today, could we distribute them?” The answer is almost certainly ‘No,’ states the head of the International Air Transport Association.

The pandemic has revealed shortcomings in global supply chains and forced business to make logistics a bigger strategic priority. Nonetheless, the air-cargo industry is making plans for delivering as many as 20 billion Covid-19 vaccination doses, even before regulators have approved any of the treatments under development. (Pharma companies say they expect the bulk of vaccines to be transported by air.)

Carriers such as FedEx, DHL,and UPS have started preparations such as introducing new temperature-monitoring systems to track future vaccine shipments. They are building “freezer farms” combining multiple refrigerators at their airport hubs to store vaccines in transit. Vaccines have to be kept at a very low constant temperature throughout the journey to prevent spoiling.

Cargo flights are fast filling up through February with bookings for consumer electronics, apparel and industrial parts through the holiday season and new year. Cargo executives said they expect it will take 2 years for a vaccine to reach all of the world’s population, with particular challenges in some emerging markets where infrastructure is limited. Fortunately, the air-cargo industry isn’t starting from scratch. Pharma products have been one of the fastest-growing and most profitable cargo types over the past decade.

Classroom discussion questions:

Why is this such a complex logistics issue?
What OM approaches can be deployed to increase the distribution efficiency?

OM in the News: Vaccine Supplies Won’t Be Enough for Everyone at High Risk

Should doctors and nurses get vaccinated before the general public?

Initial supplies of any successful coronavirus vaccines are now expected to fall short of what is needed even for high-priority groups like health-care workers, forcing drugmakers and U.S. officials to grapple with the thorny question of who should be first in line. Public-health officials estimate more than 100 million Americans, including doctors and nurses, other essential workers and nursing-home residents, should get vaccinated before the general public.

Yet initial supplies now look like they will cover only a fraction of the high-priority groups, if a vaccine clears testing and is authorized in the fall, reports The Wall Street Journal (Aug. 7, 2020).

There may be 10 million to 20 million doses available at first. The limited initial reserve is forcing U.S. health officials and their advisers to make hard choices about who should get vaccinated first. It could mean prioritizing staff at hospital emergency departments and intensive-care units over health-care workers who have less interaction with the sickest patients. But if a vaccine is shown to be protective in the elderly, they may end up getting high priority because older people are at higher risk of severe disease. Officials are also weighing how high to prioritize people who work outside of health care but in important jobs like those in the food supply chain.

Companies working on vaccines say they are ramping up manufacturing to eventually produce hundreds of millions of doses, but that bigger supply is unlikely to kick in until next year. The most difficult allocation decisions will be in the first 6-9 months of vaccine availability, but then supplies should begin to catch up to the broader population.

Classroom discussion questions:

From a business perspective, who should receive early vaccinations?
From an ethical perspective, who should be vaccinated first?