Experts warned of short supply of crucial raw materials; late delivery of bio-reactor giant plastic bags can set back production by weeks, delaying delivery of millions of much-needed vaccines
In March 2020, vaccine innovator companies started working on how they would set up manufacturing and supply chains to produce the novel coronavirus disease (COVID-19) vaccines.
The world could come up with the COVID-19 vaccines in a matter of a few months because the production and supply teams worked in parallel with the scientists in the laboratories, not knowing whether their vaccine would make it to the finishing line.
Their efforts are clear to see. At the end of this month, three billion COVID-19 vaccine doses would have been made by four vaccine manufacturing powerhouses: China, the European Union, the United States and India. By the end of 2021, it is estimated that over 10 billion doses would have left the production lines.
As part of the manufacturing preparations, the first of today’s 300 collaborations were being drawn very early on. Today, cooperation is taking place in many parts of the world — in the US, China, EU and India — but also South Africa, India, Brazil, Argentina, Malaysia, Turkey, Thailand, Egypt, Mexico, Indonesia and Iran.
Getting collaborations up and running takes time. Aspen Pharma in South Africa and Johnson & Johnson (J&J) agreed to work together in November 2020 for the fill and finish process to put the vaccines into vials. Aspen plans to have the vials leaving the manufacturing lines at the end of June.
Another early preoccupation involved checking the supplies of raw materials and the equipment needed, as well as finding and training the staff to ensure a smooth running and necessary quality checks.
The numbers are telling. It takes 280 components to make the Pfizer-BioNTech messenger-RNA vaccine (mRNA), involving 86 suppliers located in 19 different countries. These materials need to reach three different manufacturing plants, where the vaccines will go through a manufacturing process that involves 50,000 production steps and at least 70 quality checks.
Now multiply that by the number of vaccines that have been approved.
Collaborations to make vaccines are not easy. We have seen that even seasoned partners experience difficulties. Emergent BioSolutions who were helping with the production of J&J vaccines threw away millions of doses, because they did not meet the necessary quality control.
Experts have been warning since March this year that some crucial raw materials are in short supply. A late delivery of the bio-reactor giant plastic bags can set back production by weeks, delaying the delivery of millions of much-needed vaccines.
In other cases, it is difficult to find skilled technicians needed to oversee the production and check the quality and safety through the process. In addition, trade barriers have been hindering the flow of these goods, the vaccines themselves.
Adar Poonawalla of the Serum Institute tweeted recently, calling the US president to lift the embargo of raw material exports out of the US so that vaccine production can be ramped up.
We have been concerned that despite our efforts, COVID-19 vaccines currently are not equally reaching all priority populations worldwide. We have laid out five steps that urgently need to be addressed. We are calling for dose sharing. We commit to support by making any uncommitted doses available. We backed up our words with action within days, with 3.5 billion extra doses pledged by major vaccine manufacturers at the G20 Health Summit in May.
We commit to continue efforts to optimise production. The supply situation remains challenging for critical input supplies, such as bioreactor bags, single-use assemblies, cell culture media, filters, lipids and vials and stoppers. Vaccine innovators will, of course, continue to work closely with their suppliers to avoid disruption where they can.
But in the case that suppliers might have stocks that have not yet been tapped for whatever reason, we trust that the COVAX supply chain and manufacturing task force can direct its immediate attention on creating a voluntary partnership to improve visibility of the supply of manufacturing input and to facilitate the establishment of global trade processes for the free movement of raw materials, vaccine components and assay reagents.
We have learnt so much over the past 18 months, and we will be learning more as we hope to hit the target production to meet the world’s needs. For innovative bio-pharmaceutical companies, the work is far from over. We have our work cut out for us.
We continue to prioritise the development of new COVID-19 vaccines, including vaccines effective against new variants as well as looking for new formulations for easier and longer storage.
For this work to continue, we urge governments to guarantee unhindered access to pathogens of any COVID-19 variants to support the development of new vaccine and treatments. If this does not run smoothly, it will impact booster development and will hamper the World Health Organization’s ability to respond to the next seasonal influenza viruses.
In the last couple of days, we have joined the G7 future pandemic preparedness partnership to achieve a moon-shot target of 100 days to develop a vaccine in the case of a future pandemic. Cutting down from the already historic 326 days to bring a first COVID-19 vaccine.
Thomas Cueni is the Director General, International Federation of Pharmaceutical Manufacturers and Associations
Views expressed are the author’s own and don’t necessarily reflect those of Down To Earth
An abridged version of this article was first published in DTE print edition dated 16-30 June, 2021
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