One of the greatest hurdles to immunising the world’s population is the challenge of manufacturing it. Governments and NGOs around the world quickly recognised the scale of the manufacturing challenge ahead and have spent billions in recent months to fund a scale-up of production, even before a vaccine was ready to roll out. In this blog our experts look at how manufacturing is supporting the production of the Covid-19 vaccine.
In February 2020, the World Bank and the Coalition for Epidemic Preparedness Innovations (CEPI) – which funds development of epidemic vaccines – co-hosted a global consultation dedicated to funding the development and manufacture of a Covid-19 vaccine. The result of this consultation was the launch of a Covid-19 vaccine development task force, that has since been working on how to finance the development and manufacturing of vaccines for global access.
Production at scale
Once the scale of the Covid-19 pandemic became apparent, so did the urgency for an effective vaccine. However before a vaccine had even been identified, there was an awareness that when the time came it would need to be produced rapidly and on a previously unseen scale.
“What is unique is we have to go so fast and so huge,” says Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “When Ebola was a problem in Central Africa, with a few hundred thousand vaccines you could get it under control. Here you need billions of vaccines.”
The industry needed to start preparing for manufacture early in order to meet the expected production demand. This preparation was done in parallel with the clinical research. To make this preparation a possibility, scientists, regulatory bodies and industry needed to work together in a way – and at a rate – never seen before.
“The collaboration is unprecedented,” Stoffels adds. “If I look at how we work today with the regulators in the world, where normally we have paper processes which take weeks and months to get feedback, today we talk about getting feedback from regulators within the day.”
This change in process allowed for the organisational aspects to be fast tracked. There was of course financial support from governments across the globe.
In the U.S., “Operation Warp Speed” was created, it is a $10 billion initiative funded by the federal government, involving significant military involvement to support the production of 300 million Covid-19 vaccine doses by early 2021.
In Europe, the European Commission launched a €2.7B Emergency Support Instrument (ESI). It was tasked with funding manufacturing costs – through advance purchase agreements – with individual vaccine companies on behalf of EU countries. These agreements entitled investors to have the right to buy a specified number of vaccine doses in a given time frame and at a given price.
The prevalence of Covid-19 and its subsequent effect on countries – and economies – around the globe has led more than 100 vaccines being in development, all hoping to be the one to eventually provide a cure for Covid-19.
Vaccine developers are choosing contract manufacturing organisations (CMOs) for their Covid-19 vaccine: America, the United Kingdom and Germany are some of the most popular supplier locations. This is in direct contrast with the usual trend within the pharma industry to outsource production to China and India, especially for low-cost, high-volume orders.
In fact, the UK’s capability to manufacture vaccines received a substantial boost in July, when the government announced an additional £100 million to ensure that any successful Covid-19 vaccine can be produced at scale in the UK.
The investment funded a state-of-the-art Cell and Gene Therapy Catapult Manufacturing Innovation Centre to accelerate the mass production of a successful Covid-19 vaccine in the UK. Due to open in December 2021, the Centre will ensure the UK has the capacity to produce millions of doses each month. The Centre will also put the UK clearly on the map as being able respond to diseases like coronavirus and to prepare for potential future pandemics, while also fuelling the UK’s economic recovery by creating new, high-skilled jobs.
The new centre will complement the Vaccines Manufacturing and Innovation Centre (VMIC) – itself funded by a £93 million pound government investment – which once complete will have the capability to produce enough vaccine doses to serve the entire UK population at scale.
The Covid-19 pandemic has catapulted UK vaccine manufacturing into a new orbit, and has drastically improved communications with regulatory bodies. The UK will in fact be the first country to start immunising its population with an approved Covid-19 vaccine developed by Pfizer. This new direction could be incredibly important as the UK steps away from the EU.
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