Millennium Post

Heading backwards?

The regressive trend in the supply of crucial raw materials for vaccine production could be resolved through a coordinated fight

Heading backwards?

In March 2020, vaccine innovator companies started working on how they would set up manufacturing and supply chains to produce COVID-19 vaccines. The world could come up with the vaccines in a matter of a few months because the production and supply teams worked in parallel with the scientists, not knowing whether their vaccine would make it to the finishing line.

Their efforts are visible now. At the end of this month, three billion COVID-19 vaccine doses will be made by four vaccine powerhouses: China, the European Union, the United States and India. By the end of 2021, it is estimated that over 10 billion doses will leave 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 — not only in the US, China, EU and India — but also in South Africa, 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 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 smooth running and quality checks.

The numbers are telling. It takes 280 components to make the Pfizer-BioNTech messenger-RNA (mRNA) vaccine, 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, involving 50,000 production steps and at least 70 quality checks.

Collaborations to make vaccines are not easy. We have seen that even seasoned partners experience difficulties. Emergent BioSolutions that 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 bioreactor 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 tweeted recently, calling the US president to lift the embargo on raw material exports out of the US so that vaccine production can be ramped up.

Despite our efforts, 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.

The supply situation remains challenging for critical input supplies, such as bioreactor bags, single-use assemblies, cell culture media etc. Vaccine innovators will, of course, continue to work closely with their suppliers to avoid disruption where they can.

But, in case suppliers have untapped stocks, 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 will continue 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 variant to support the development of new vaccines. If this does not run smoothly, it will hamper the World Health Organization's ability to respond to the next seasonal influenza viruses.

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 the historic 326 days to bring the first COVID-19 vaccine. DTE

Views expressed are personal

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