COVID-19 vaccine roll-out becomes largest in supply chain history.

The introduction of the COVID-19 vaccine is becoming the biggest challenge for chemical supply chains in history.

The launch of the COVID-19 vaccine is becoming the biggest challenge for chemical supply chains in history. Here's why.

In 2020, all aspects of life were affected by the Corona virus. Whether in meetings at work, meeting friends in the evening, visiting family members at home or in care facilities, everything was or is affected by the Corona pandemic and its restrictions.

Right now, in the late 2020s, several pharmaceutical companies are in the process of developing specific vaccines that have already gone through most phases of the drug discovery landscape, from structural characterization, design, chemical synthesis or recombinant technologies, to preclinical testing, to phase 0, 1, 2a, b, and even phase 3.[1]

The most well-known and completely new vaccine design approaches have been pursued 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 is one of the non-replicating viral vectors. It was developed in collaboration with the University of Oxford and the spin-off company Vaccitech.
Moderna and BioNTech's vaccine candidates are mRNA-based vaccines consisting of, for example, nucleoside-modified mRNA encoding a wild-type of the spike protein of SARS-CoV-2 and encapsulated or packaged in lipid nanoparticles as a drug delivery system.[2]

While Moderna's mRNA-1273 is in phase 3 drug development and approval process and has submitted an expedited application which is currently under review and approval by the US FDA, UK MHRA and EU EMA[3] - as of today, 10/12/2020, BioNTech's BNT162b2 vaccine has been approved in the U.K.[4]Bahrain and Canada.[5] The first patients have already been vaccinated in the UK.[6]

Bottlenecks within the chemical supply chain.

Since the above candidates are very promising, experts are already concerned about upcoming problems and bottlenecks within the chemical supply chain. During and after 2020 and 2021, the production and distribution of a COVID-19 vaccine will require adequate storage, transportation and tracking activities worldwide. Experts anticipate billions of vial doses. This represents the largest supply chain challenge in history, especially in light of the fact that two repeat vaccinations are favored.[7]

Supply chain and logistics experts expressed their concerns that international and national networks are not ready for the production and distribution of a licensed vaccine with such high volumes and urgency. Handling the vaccine under cold chain requirements, such as -70 °C for BioNTech's vaccine, will also be a major challenge.[8]

Current sticking points and bottlenecks within the chemical supply chain have been identified in the areas of logistics, production and storage capacity, cold chain technologies and requirements, national infrastructure, and security and corruption.

The following describes a high-level supply flow, starting from a Tier 2 supplier, through production, to the customer.

Entourage pain points within supply chains

The overarching goal for the coming months and years is to build a robust chemical supply chain with a closely coordinated, cross-company and cross-functional process landscape and a lean, fully traceable flow of information supported by modern IT solutions.

After identifying the current weaknesses and bottlenecks in the supply chain, a root cause analysis led to the following strategic improvement opportunities to overcome the current weaknesses.

Entourage possivilites for improvement

Redesigning the supply chains of the future.

This may require a redesign of the supply chains of the future, which must be characterized by flexibility, accountability, and real-time transparency. These chemical supply chains will help communities, individual countries or individual companies around the world better manage short-term crises and help save millions of lives.

Currently, companies are already testing different ways to build more resilience into their manufacturing and supply networks, even if this resilience adds costs. Activities such as diversifying manufacturing and supply networks, adding back-up production and distribution capacity, or optimizing inventory management are already in place. In addition, companies are trying to improve their supply chain flexibility, risk monitoring, and remediation planning and execution.

As supply chain risks have been identified in the twenty-first century, leaders need to build such a robust system for the future, as mentioned above. It will include a supply chain risk function that includes risk assessments, risk registers focused on probability and impact, and mitigation and remediation strategies. In addition, digital supply chain activities will be important as they will improve speed, accuracy, transparency, flexibility and cross-enterprise collaboration.

Pfizer / BioNTech has learned in recent days 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]

Against this background, the COVID 19 pandemic can be seen as a kind of wake-up call to reconsider typical procedures, to think about alternatives or upcoming challenges, and also to consider that the whole globe is interdependent when it comes to the efficient management of such disasters. 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 won't 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.

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Persons to the article.

Dr Ralf Hess

Principal Consultant IVD

Dr. Ralf Hess studied biology at the Albert-Ludwigs-University of Freiburg, where he also completed his doctorate at the Institute of Virology. Dr. Hess has many years of experience in the development of medical devices and medicinal products and their combination, in laboratory analysis and quality assurance. The quality expert has set up, implemented and maintained QM systems in accordance with ISO and GxP for various areas of application. The customer service portfolio ranges from manufacturers of classical and biological drugs, medical device companies and vaccine manufacturers to immunohistochemical, immunological, molecular biological and serological diagnostic laboratories. Dr. Hess works worldwide as an auditor in the GxP/ISO area and has many years of experience in FDA remediation projects and the regulatory development of combination products (drug device products).
Dr. Ralf Hess supports Entourage as Principal Consultant IVD.

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