COVID-19 vaccine industry cautions immediate action needed to remove manufacturing supply barriers to meet production targets and keep on course to equitable and fair access to COVID-19 vaccines

  • On the 1st anniversary of ACT-Accelerator, COVID-19 vaccine makers representing biotechnology firms, developing and developed country manufacturers renew their commitment to produce sufficient vaccines to meet world needs.
  • Increased production output of COVID-19 vaccines is forecast and can be attributed to over 200 manufacturing deals coming online and greater efficiency of a complex process, however, the manufacturing scale up depends on overcoming major manufacturing supply challenges.
  • Vaccine industry warns that their manufacturing scale up projections are dependent on immediate action being taken to promote the free flow of goods and trade as well as better visibility of demands on supplies.

23 April 2021: Washington DC, Geneva, Hyderabad: The Biotechnology Innovation Organization (BIO), Developing Countries Vaccine Manufacturers' Network (DCVMN) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) are all key players in the historic effort to scale up the manufacturing of COVID-19 vaccines. All three entities signed up as partners of ACT-Accelerator last year and committed to fair and equitable access to COVID-19 vaccines. This month, on the first anniversary of the ACT-Accelerator, the 1 billion COVID-19 vaccine production milestone has been reached, and current projections[1] to produce close to 10 billion doses by the end of 2021 is thought to be feasible. According to a recent World Bank report[2], this should be sufficient to achieve global equity in the distribution of vaccines and attain worldwide herd immunity by March 2022.

This forecast is based on over 275 manufacturing deals that have been agreed to date coming on-line. Of these deals, 214 include various forms of partnership or collaboration that rely on technology transfer. There are early signs that the sharing of know-how of the processes and the technologies used to make the vaccines, as well as training specialist personnel to ensure quality standards throughout the process, are now starting to have an impact on the projected output. As these facilities get up to speed, they are able to produce more vaccines, as well as achieve increasingly better yields.

But the vaccine industry groups warn that success in achieving the manufacturing targets which by the end of 2021 should meet the needs of 70% of the world's population, hinge on resolving immediately trade barriers and removing export restrictions that hinder the movement of global supply of vaccine components and the vaccines themselves during the manufacturing process. The demand on vaccine raw materials, ingredients and manufacturing components will need to meet the demand associated with the increase in vaccine production. This is of particular concern since there is currently a global shortage of some of the over 100 components and ingredients needed for vaccine manufacturing. While a great deal of focus has been put on ensuring there are enough vials or syringes; today we are seeing shortages in the lipids that are used in mRNA vaccines; as well as tubing and the plastic bags that are used in the production process for many vaccines.

The three vaccine industry groups have been actively engaged in highlighting these currents together with COVAX, both at the Global COVID-19 Vaccine Manufacturing Supply Chain Summit in March 2021, as well as more recently at a WTO event "COVID-19 and Vaccine Equity: What can the WTO Contribute". These discussions have started to point towards a number of potential short-term solutions; namely:

  • Further exploring voluntary manufacturing partnerships where feasible.
  • Removing current export restrictions and ensuring free flow of goods and workforce across the world.
  • Facilitating and speeding up of trade in the global supply chain of COVID-19 vaccines and their components. This would require the involvement of the World Trade Organization and the World Customs Organization.
  • Identifying and finding solutions to constraints of raw materials, critical components and technology for vaccine manufacturing. Industry believes that a voluntary scheme for increasing visibility on demand and supply of COVID-19 vaccine components could improve the efficiency of the market place. The vaccine industry groups would welcome the creation of a clearing house or hub managed by a trusted third party to head off problems before they occur by knowing where there could be spare resources or bottlenecks in supplies of critical items.

The recently announced COVAX manufacturing task force where industry intends to play a key role, needs to see these solutions through from concept to reality within the next month. In the following months, the taskforce would be the appropriate forum for vaccine makers to share their experience of technology transfer and contribute to exploring the skills set needed to build a platform for sustainable vaccine manufacturing.

Quotes:

Roger Connor, President, Global Vaccines, GlaxoSmithKline & Vaccines CEO representative on COVAX:

"Collaboration and determination across all stakeholders to end this pandemic, has delivered an incredible scientific, manufacturing and deployment effort to develop, produce and make available new vaccines to many countries in the world within just one year. We need to keep this going, to unblock bottlenecks, and make more vaccines available to more people across the world, in order to end the global pandemic".

Sai Prasad, Executive Director, Quality Operations, Bharat Biotech, President, Developing Countries Vaccine Manufacturers' Network (DCVMN):

"Within the short span of a year, since the start of the COVID-19 pandemic, vaccine innovators and manufacturers have solved a variety of problems by making available several safe and efficacious vaccines, enabling global partnerships towards product development, manufacturing, and scale up to several billion doses. Vaccines have been delivered to more than 120 countries. We now must strive towards global equitable access to leave no one behind, this target too will be achieved".

Dr. Michelle McMurry-Heath, President & CEO, Biotechnology Innovation Organization (BIO):

"Our researchers in the labs have worked tirelessly to find the scientific solutions we need to end this pandemic through aggressive partnerships with governments and others in industry. We most certainly agree that global access to COVID-19 vaccines is a public health and humanitarian imperative since no one is safe until we are all safe. Achieving this goal will require strong support from developed countries and continued global collaboration to ensure universal access to COVID-19 vaccines."

Rajinder Suri, Chief Executive Officer, Developing Countries Vaccine Manufacturers' Network (DCVMN):

"I strongly believe that when virus doesn't recognise any barriers why vaccines should? A free flow of vaccine production components would certainly help attain desired objective of equitable access".

Thomas Cueni, Director General, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA):

"We are on track to procure 10 billion doses, thanks to numerous manufacturing partnerships, including over 200 that involve technology transfer. And we are on track because industry is doing what society and all of you would have expected us to be doing. But vaccine supply chains are global and export controls threaten these supply chains. We also need for greater visibility into the supply chain, which would help avert bottlenecks. A simple breakdown in the supply of bioreactor plastic bags can set back output by weeks or even months. The way out of this pandemic is to increase vaccine production as fast as possible; and action is needed now".

[1]Airfinity

[2] A World Bank report "How to End the COVID-19 Pandemic by March 2022"

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