Manufacturing key to overcoming the next pandemic

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Ben Hargreaves looks at the way governments are preparing for a future pandemic. One of the key lessons from COVID-19 was ensuring that sufficient manufacturing capacity is readily available, and this is the area where investment and action are taking place.

With the worst of the COVID-19 pandemic not long past, the effort required to contemplate another such event is difficult. Yet, this is what the pharmaceutical industry and governments globally are tasked with doing. Earlier this year, WHO chief, Tedros Adhanom Ghebreyesus, stated that “the threat of another pathogen emerging with even deadlier potential remains.” He concluded that the world needed to be ready to answer decisively, collectively, and equitably to the next pandemic.

In light of the impact of the COVID-19 pandemic, WHO’s 194 member states established a process to draft and negotiate a new accord on pandemic preparedness and response. The aim is to address the gaps that were highlighted by the pandemic, including preparedness and response arrangements, sustained funding, and governance and oversight mechanisms to increase trust in the process. A priority for such action will be addressing the hurdles that were faced in the early stages of the pandemic, particularly the challenges over the manufacture and scale up of operations to be able to vaccinate the global population.

Learning from the past

Drew Burch, EVP of nucleic acid products at TriLink BioTechnologies, spoke with pharmaphorum about what some of the initial difficulties were when developing and then producing vaccines. Burch noted that the limiting factor for countering any infectious disease threat is vaccine development, but that this was mitigated by the rapid way in which mRNA vaccines could speed up the R&D process – from genetic code to a working vaccine.

However, he added: “In terms of manufacturing, the supply chain challenges really started to impact all development and production activities. Given the urgency and need for the COVID-19 vaccine, organisations were able to prioritise and obtain supply for development. However, restrictions between national borders stood in the way of obtaining necessary materials.”

This is why the European Commission has already moved ahead with its own action to prepare the region ahead of any future pandemics – to ensure a unified response in the future. The project was commissioned by the EU4Health programme, which was adopted in response to the COVID-19 pandemic and aims to address long-term health challenges across the region. The programme will run from 2021 through to 2027, and has a budget of €5.3 billion during this period.

At the end of June, the EU4Health programme signed a framework contract with ‘four contractors’ to set up a network that would provide “sufficient and agile manufacturing capacities for different vaccine types” to protect citizens from cross-border health threats. The network includes Pfizer, C2 Vaccines, Laboratorio Reig Jofre and Laboratorios Hipra, and Bilthoven Biologicals, which sees the network possess manufacturing bases operating out of Belgium, Ireland, the Netherlands, and Spain. The different vaccine types that are covered by this arrangement are mRNA, vector-based, and protein-based vaccines, and the agreement will be called the EU FAB network.

Burch outlined that it is important to prepare capacity against potential threats; however, he noted that doing so does not guarantee that the capacity will be relevant against the specific infectious disease.

Burch stated: “It’s important to note that the capacity for responding to a pandemic depends on the drug that can be useful in that specific pandemic. Early in the [COVID-19] pandemic, when we thought certain medicines might be useful, there was a scramble to address the capacity of those medicines. As it turned out, that wasn’t really useful until the mRNA vaccine came along, and that, of course, was all new, driving a need for new production processes. In short, sometimes we can leverage existing capacity, and sometimes we cannot.”

This goes some way to explaining why the EU has chosen to cover four types of vaccines as part of its strategy – to ensure the most effective vaccine, regardless of type, can be scaled. According to EU FAB, the deal will secure 325 million doses per year of vaccine, in the case of a public health emergency. The capacity will be kept operational and can be activated quickly, the partners stated, and will help to bridge the gap between initial development of a working vaccine and the scale up required to produce vaccines for the region. 

The network will operate on a two-stage process, outlined by EU FAB as follows: 

“Preparedness phase: EU FAB reserves the necessary manufacturing capacity. The EU FAB facilities ensure their constant readiness to respond to a crisis by keeping their facilities up to date, ensuring staff is trained, and monitoring their supply chains, including stockpiling where necessary.

Crisis phase: Following the recognition of a public health emergency, the Commission decides to purchase vaccines and activate EU FAB. The EU FAB facilities will then rapidly start production and deliver the vaccines according to the deadlines set in the purchase contracts.”

The response across the Atlantic

The European Union is by no means alone in preparing for a new potential pandemic threat, as countries and organisations globally format plans to counter another global event on the scale of COVID-19.

At the beginning of July, the US officially launched the ‘Office of Pandemic Preparedness and Response Policy’. The office has been created to coordinate the country’s domestic response to public health threats. As well as emerging viral threats, this also includes work against existing issues, such as human influenza and RSV.

This builds on a report released in September 2021, detailing the country’s plans to transform its capabilities when dealing with a threat of the scale of a future pandemic. At the core of the report were five conclusions of areas that needed to be strengthened, which were outlined as follows:

  1. Transforming our Medical defences by dramatically improving medical countermeasures (MCMs) to include vaccines, therapeutics, and diagnostics.
  2. Ensuring situational awareness about infectious-disease threats, for both early warning and real-time monitoring.
  3. Strengthening public health systems – including workforce support, training, and development – in the United States and internationally to respond to emergencies, with a particular focus on protecting the most vulnerable communities.
  4. Building core capabilities, including innovation in personal protective equipment (PPE), restoring and expanding stockpiles and building resilient supply chains, acceleration of biosafety and biosecurity innovation, and improvement in regulatory capacity and both global and domestic clinical trial networks.
  5. Managing the mission, with a seriousness of purpose, commitment, and accountability.

Similarly to the EU’s recent action, ‘building core capabilities’ is primarily led by improving manufacturing capabilities. As such, the US announced six separate manufacturing steps to establish greater capacity across the country. This included setting up the RESPOND network, which features manufacturing stakeholders contributing resources, tools, and workforces to provide a framework for accelerated crisis response. The US also revealed it had set up a National Biopharmaceutical Manufacturing Partnership to expand manufacturing capacity for medical countermeasures.

Burch outlined that TriLink BioTechnologies, a contract development and manufacturing organisation working with nucleic acids, NTPs, and mRNA, had been one of the beneficiaries of the US’ efforts to build up such capacity: “Infrastructure is key to a streamlined supply chain. We've just taken occupancy on the second production building for CleanCap technology and for other raw materials in San Diego, California, so that we can ensure we'll be ready for our customers and for the patients who may be waiting in a future pandemic. Through BARDA, the US government helped us finance the standby capacity.”

All of the investment flowing into preparing against another pandemic-level threat is dwarfed by the actual cost of the COVID-19 pandemic. Research emerging from USC Schaeffer estimates suggests that the total cost to the US economy alone will reach $14 trillion by the end of 2023. As such, the money poured into prevention far outweighs the overall impact when an event as significant as COVID-19 occurs. This was confirmed by a study published by Harvard’s School of Public Health, which found that primary pandemic prevention actions are less than 10% of the economic cost, and less than 5% of the lowest estimated value of lives lost. Having the manufacturing capacity to quickly scale up production of working vaccines is such a preventative action. This is why the efforts undertaken by the US and EU to bolster capabilities will likely continue, ensuring a pandemic of the scale of COVID-19 has a lower chance of taking hold.