What is causing the COVID-19 vaccine supply chain disruption?

Today’s blog is contributed by Ankita Pundir and Mayur Patil, two Industrial Engineering students who worked on creating these insights as part of the SCRC’s COVID-19 research team.

“What’s behind the Nitrile Glove Shortage?”

“Issues with PPE counterfeits and quality”

“Why Precious Doses of COVID-19 vaccine keep getting dumped”

“COVID-19 Vaccine supply vulnerable to Cyberattack

These are few of the many headlines that have stormed the internet, related to COVID-19 vaccine supply. So, what are the possible causes behind these? From glass and rubber shortage to potential cyberattacks threats, there are hundred different ways things can go wrong. Just as COVID testing stumbled upon several obstacles (still is), similarly vaccine supply chain has started facing issues.

The first of many disruptions involves raw material shortage. And it’s not just vaccine raw material that we are talking about. Vaccine doses need a particular glass vial for its storage, in order to avoid any kind of contamination and breakage issues. Borosilicate glass is that particular kind we are talking about. There are approximately 70 borosilicate glass manufacturers in USA alone, but not many of them are ready for the upscale production that COVID vaccine doses require. Big players in the market like Schott, Gerrescheimer (both German), Stevanato Group (Italian), and Corning (USA) say they are ready to face the challenge, but this is considering only 2 companies have got EAU approval for vaccine production for now. Many more are on the way. Companies like Corning (Valor glass) and Si02 (produces medical grade plastic coated with pure silica to hold vaccine doses) are manufacturing alternatives to the borosilicate glass, which is a good sign.

Next comes Rubber which is another major raw material. The glass vials need rubber stoppers; PPE kits require rubber gloves. The US is already started facing nitrile glove shortage. At present, PPE testing kits are facing glove shortage and that is now burdened with vaccine administration glove requirement as well, since vaccination kits don’t come along with Nitrile gloves.

According to reports, the global demand for nitrile gloves reached around 600 billion by the end of 2020, while the then current level of manufacturing was only around 400 billion.

With the Defense Production Act (DPA) coming in picture, which requires domestic manufacturers to prioritize COVID-19 vaccine related supply production for US government orders, the situation may take a better turn. The Biden administration has elected to use the DPA as a means to issue financial incentives to suppliers in order to help ramp up their production. Second, to invest in other potential vaccine providers, by using its contract authority. The current administration has identified 12 items (N95 masks, high quality surgical masks, test reagents, pipette tips, nitrile gloves, etc.) facing critical supply shortage and is likely to put more resources into it, under DPA.

In addition to raw material shortages, vaccine storage and transportation is also proving to be a major hindrance. As of now, two vaccines (Moderna and Pfizer) have been given EAU approval, AstraZeneca still expecting approval by the end of April.

The Moderna vaccine needs to be stored between temperature range of -8 F to -13 F. While Pfizer vaccine requirement is even more complicated, requiring ultra-cold refrigeration, temperature of -94 F to be precise, for safe storage and transportation. Current practice of vaccine logistics is using dry ice and gel packs, however even that has started facing issues, and not just shortage issues!

Hundreds and thousands of doses of COVID-19 vaccines are being dumped across the nation, because suppliers and 3PLs are not able to accurately maintain the required vaccine temperature. As reported by the director of Maine CDC, 4000 doses of Moderna vaccine were wasted as the boxes became too warm during shipping. A sensor on the box indicated that the temperature threshold was crossed, thus making the vaccine unfit for use. Specialty RX, a supplier of Moderna vaccine in Ohio, was suspended from future vaccine allocations, after mishandling about 900 doses of the vaccine, exceeding recommended temperature range. Various other states, like Colorado and Louisiana, faced similar hiccups, but this time due to power outages causing their refrigeration system to crash.

Michigan, on the other hand, had a different issue. Nearly 12,000 doses were deemed unfit as the vaccines were kept at a colder temperature than required.  California and Alabama experienced similar overcooling issues, this time with Pfizer vaccines, believed to be caused due to mishandling of dry ice during its replenishment amid transportation.

Cold chain clearly seems to be a problem for Moderna as well as Pfizer vaccines. Advanced temperature-controlled transportation and storage solution is the need of the hour. For instance, Skycell’s 1500 DF container can prove to be a good solution for Pfizer vaccine as it can maintain an accurate temperature of -94 F, with 120+ hours of independent runtime and is safe for transportation via truck and air freight, each container capable to carry over 40,000 doses. It is designed in a unique way to carry almost 50 such containers fitting in 1 aircraft, averaging about 1.75 million vials.

Mecotec Group on the other hand has developed a mobile hybrid container with active deep cooling technology, that can help transport 1 million vaccines at temperature of -94 F, without using any dry ice. This can prove to be an ideal solution if dry ice shortage is faced by vaccine suppliers. This container serves as a storage cum transport system.

Even if the above challenges are tackled, there is still a potential threat of cyberattack. The global vaccine supply can come to a halt from a ransomware threat from high-tech criminals. Rather than their need of steeling data, they can cut access for people who need that data by encrypting it. This would essentially mean, blackmailing the governments for ransom in exchange of decrypting the data to get their business back up and running.

 References

  1. https://www.schott.com/innovation/en/answering-the-hard-questions-about-pharmaceutical-packaging-supply/
  2. https://www.schott.com/english/news/press.html?NID=com5590
  3. https://www.schott.com/english/news/press.html?NID=com5797
  4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7531934/
  5. https://www.defensenews.com/opinion/2021/01/21/biden-should-focus-defense-production-act-on-fixing-the-covid-supply-chain/
  6. https://torontosun.com/news/national/covid-19-vaccine-supply-vulnerable-to-cyberattack?utm_campaign=other&utm_source=LINKEDIN&utm_medium=social&utm_region=global&utm_content=default&utm_creative=default&utm_term=default&utm_keyword=na&linkId=109736834
  7. https://www.npr.org/2020/12/18/948030235/pfizer-says-millions-of-vaccine-doses-are-ready-but-states-say-shipments-were-cu
  8. https://www.thedailybeast.com/why-precious-doses-of-covid-19-vaccine-keep-getting-dumped?ref=scroll
  9. https://www.skycell.ch/covid-19.html