COVID-19 Vaccine Roll-Out. About to become largest. In Supply Chain History.

COVID-19 Vaccine Roll-Out. About to become largest. In Supply Chain History.

Dr. Andreas Benischke & Dr. Ralf Hess, 10th December 2020.

The roll-out of the COVID-19 vaccine is becoming the biggest challenge for the chemical supply chain in its history. Here’s why.

In 2020 all areas of life were affected by the corona virus. Whether it was holding meetings at work, seeing friends in the evening, visiting family members at home or in nursing facilities, everything was or still is impacted by the corona pandemic and its restrictions.

Right now, at the end of 2020, several pharma companies are about to develop specific vaccines, which have already passed most phases of drug discovery landscape, from structural characterization, design, chemical synthesis or recombinant technologies via pre-clinical investigation up to phase 0, 1, 2a, b and even Phase 3.[1]

Most famous and fully new vaccine design approaches have been taken by Moderna with mRNA-1273, by BioNTech and Pfizer with BNT162b2, by CureVac with its CVnCoV and by AstraZeneca with AZD1222. The latter is a modified chimpanzee adenovirus vector (ChAdOx1), which belongs to non-replicating viral vectors. It has been developed in collaboration with the University of Oxford and the spin-off company Vaccitech.
The vaccine candidates of Moderna and BioNTech are mRNA-based vaccines composed of for example nucleoside-modified mRNA encoding a wildtype of the spike protein of SARS-CoV-2 and are encapsulated or packed in lipid nanoparticles as a drug delivery system.[2]

While Moderna with its mRNA-1273 is in phase 3 of the drug development and registration process and has submitted an urgent application proposal which is currently pending for review and approval by US FDA, UK MHRA and EU EMA[3] – as of today, Dec 10, 2020, BioNTech’s BNT162b2 vaccine has been approved in the UK[4], Bahrain and Canada.[5] In UK, the first patients have already been vaccinated.[6]

Bottlenecks within the Chemical Supply Chain.

Since these above-mentioned candidates are very promising, experts are already thinking about upcoming issues and bottlenecks within chemical supply chain. During and after 2020 and 2021, the production and distribution of a COVID-19 vaccine will require worldwide adequate storing, transport and tracking activities. Experts expect billions of vial doses. This represents the largest supply chain challenge in history, especially in light, that two repeated vaccinations are in favor.[7]

Supply chain and logistics experts expressed their concern that international and national networks are not ready for manufacturing and distributing a licensed vaccine with such high volumes and urgency. One major challenge will also occur by handling the vaccine under cold chain requirements, such as -70 °C for the vaccine of BioNTech.[8]

Current pain points and bottlenecks within chemical supply chain have been identified within logistics, manufacturing and storage capacity, cold chain technologies and requirements, national infrastructure and within security and corruption.

In the following, a high-level supply flow is described starting from a Tier 2 supplier via production to customer.

The overall goal in the upcoming months and years will be the design of a robust chemical Supply Chain with a closely aligned intercompany and cross-functional process landscape and streamlined fully traceable information flows supported by advanced IT-solutions.

Upon the identification of present Supply Chain vulnerabilities and bottlenecks, a root cause analysis has resulted in the following strategic possibilities for improvement to overcome current weaknesses.

Reshaping Future’s Supply Chains.

This may necessitate a reshaping of supply chains of the future and will need to be characterized by flexibility, responsibility and real-time visibility. These chemical supply chains will support communities, individual countries or single companies all over the world with better managing of short-term crisis and contribute to saving millions of people lives.

At the moment, companies are already exploring various ways to build more resilience into their manufacturing and supply networks, even if that robustness causes extra costs. Activities such as diversifying the manufacturing and supply networks, adding back-up production and distribution capacities or optimizing warehouse management are already present. In addition, companies try to improve their supply chain flexibility, risk monitoring, mitigation planning and execution.

Since the risks to supply chain in the twenty-first century have been identified, leaders must build such an above-mentioned resilient system for the future. It will encompass a supply chain risk function, which will include risk assessments, risk registers focusing on probability and impact as well as mitigation and remediation strategies. Furthermore, digital supply chain activities will be of major interest, since they will improve the speed, accuracy, transparency, flexibility and cross-company collaboration.

In recent days, Pfizer / BioNTech has experienced how difficult it is to expand the supply chain for such a vaccine. The originally planned 100 million vaccine doses in 2020 had to be halved to 50 million.[9]

Taking this into account, the COVID-19 pandemic can be seen as a kind of wake-up call to re-review typical procedures, to think about alternatives or upcoming challenges and also to keep in mind that the whole globe is in dependency to each other when it comes to efficient management of such catastrophes. In the end: We are all patients!

References.

  • [1]a) M. S. Diamond, T. C. Pierson, The challenge of vaccine development against a new virus during a pandemic, Cell Host Microbe 27, 699, May 13th, 2020; b) T. T Le, J. P. Cramer, R. Chen, S. Mayhew, Evolution of the COVID-19 vaccine development landscape, Nat. Rev. Drug. Discov. 19, 667, September 4th, 2020; c) COVID-19 vaccine tracker, Milken Institute, November 16th, 2020; d) Draft landscape of COVID-19 candidate vaccines, World Health Organization, November 16th, 2020; e) COVID-19 vaccine development pipeline, London School of Hygiene and Tropical Medicine, November 30th, 2020.
  • [2]a) Pfizer and BioNTech announce vaccine candidate against COVID-19 achieved success in the first interim analysis, Pfizer, November 9th, 2020; b) Moderna’s COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the phase 3 cove study, Moderna, November 16th, 2020; c) AZD1222 met primary efficacy endpoint in preventing COVID-19, AstraZeneca, November 23rd, 2020; d) CureVac and WACKER sign manufacturing contract for CureVac’s COVID-19 vaccine candidate CVnCoV, CureVac, November 23rd, 2020.
  • [3]a) N. O’Neill, Pfizer applies for emergency FDA approval of COVID-19 vaccine, New York Post, November 20th, 2020; b) C. Kitching, Moderna corona virus vaccine could get UK approval within two weeks, says expert, Mirror, December 1st, 2020.
  • [4]https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19, accessed on 10 December 2020.
  • [5]https://www.zeit.de/wissen/2020-12/corona-impfung-kanada-biontech-pfizer-zulassung-impfstoff, accessed on 10 December 2020.
  • [6]https://edition.cnn.com/2020/12/08/europe/uk-pfizer-biontech-covid-vaccination-intl/index.html, accessed on 10 December 2020..
  • [7]a) B. Gates, The vaccine race explained: What you need to know about the COVID-19 vaccine, The Gates Notes, April 30th 2020; b) P. Shukla, A. Rajput, S. Chakravarthy, How the massive plan to deliver the covid-19 vaccine could make history – and leverage blockchain like never before, World Economic Forum, July 17th 2020; c) E. Callaway, The unequal scramble for corona virus vaccines – by the numbers, Nature 584, 506, August 27th 2020.
  • [8]a) B. Murray, R. Griffin, The world’s supply chain isn’t ready for a COVID-19 vaccine, Bloomberg World, July 25th, 2020; b) S. D. Kominers, A. Tabarrok, Vaccines use bizarre stuff. We need a supply chain now, Bloomberg Business, August 18th, 2020; c) C. O’Donnell, Why Pfizer’s ultra-cold COVID-19 vaccine will not be at the local pharmacy any time soon, Reuters, November 9th, 2020.
  • [9], https://www.faz.net/aktuell/wirtschaft/unternehmen/pfizer-halbiert-auslieferungsziel-fuer-corona-impfstoff-17084380.html, accessed on 10 December 2020.