Expert insight

Momentum of COVID-19 vaccine manufacturing scale up sufficient for step change in distribution

16 September 2021
  • Thomas Cueni Director General

Last week we convened another media briefing on the biopharmaceutical industry’s efforts to ramp up manufacturing capacity for COVID-19 vaccines, treatments and supplies. We were joined by CEOs and executives from Pfizer, Roche, Merck, Johnson & Johnson, whose 3 main take-aways I would like to share with you.

The historic COVID-19 manufacturing scale up has been possible thanks to a steady increase in production, supply chain, and voluntary tech transfer agreements with partners across the world.

Life science analytics company Airfinity forecasts that COVID-19 vaccine manufacturing output will pass the 7,5 billion dose mark this month and reach 12 billion by the end of this year.

To put it into perspective, before the pandemic, annual production of all vaccines, seasonal flu included, was between 3 and 5 billion.  While this is a major achievement of scientists, medical teams and people who joined clinical trials, regulators, manufacturers – we should also call out the huge scale up and logistics involved in producing the equipment and materials needed to make the vaccines.

Dr Albert Bourla, Pfizer CEO, said that before the pandemic, Pfizer was producing, at peak, 200 million vaccines per year, across all their vaccines. For 2022, Pfizer expects to make 3 billion doses, thanks to early at-risk investment in infrastructure and to partnering with others to go fast. “The only bottleneck was raw materials availability, and in order to secure more and more raw materials, we literally created new suppliers – we helped them scale up their production, but also taught new people how to do it”.

Dr Paul Stoffels, Chief Scientific Officer at J&J, detailed the hard work that goes with finding partners for vaccine tech transfer: “Tech transfers are highly technical by nature and highly complex. We need to work with many partners. Multiple steps are needed: biological manufacturing, quality testing and release, regulatory inspections and control. We need to work with multiple countries around the world to get this done. Now we try to do this in a record time: months versus years, and we try to overcome all these challenges. The most critical is training of the workforce in new technologies. Never before have more people worked in the vaccine environment than today, and talent is very critical”.

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Belen Garijo, Merck CEO, cautioned that trade plays an important role in ensuring manufacturing can be scaled up, as materials and inputs need to move from one site to another.

Political leadership is critical to enable dose deliveries as quickly as possible, and industry is committed to support

According to Airfinity data, by June 2022, if there are no major bottlenecks and trade barriers don’t hinder the supply chain, total vaccine production is on course to reach over 24 billion.  At this point, vaccine supplies will most likely outstrip global demand.

Based on the most conservative projections, even if governments in G7 countries vaccinate teenagers and adults at a rate of more than 80% and decide to give boosters to at-risk populations, there would still be over 1.2 billion doses available for redistribution; by the end of this year. This means that governments holding back stocks in case of shortages no longer need to so do. This should a game-changer for vaccine equity.  We cannot be insensitive to the fact that only 6% of Africa’s adult population have received full vaccination, when in many of the Western countries, we are seeing rates of 70% plus.

If these 1.2 billion doses are shared out, it would mark a turning point in vaccine distribution, and open the way to reset for vaccine equity.  This is something the groups representing the innovative vaccine manufacturers and biotech companies have been calling for since May.

Going forwards, leadership and coordinated action will help ensure the step change in distribution; but also in country readiness. Removing delivery and administration bottlenecks in the countries where the vaccines are badly needed will be key. To enable this, our industry is committed to partner with governments on COVID-19 vaccine deployment, particularly in low- and lower-middle income countries, to ensure that they are ready and able to deploy available doses within their shelf life.

Let us hope, we will soon witness a turning point when we see leaders united in giving equitable vaccine distribution “a shot in the arm”.

Existing vaccines offer protection against variants, and more treatments are coming in the pipeline

Our speakers emphasized that even in the face of new variants such as Delta, current authorised vaccines show continued strong protection from infection and excellent effectiveness against hospitalisation and death. The key is now to ensure that vaccination happens quickly, to limit the arrival of new variants. Closely monitoring vaccines is going to be very critical, and if necessary, the industry stands ready to conduct the necessary scientific work to adapt the vaccines.

Still, for those people who do contract COVID-19 or are at-risk, treatments are an important and integral part of COVID-19 mitigation strategies. A handful of authorised COVID-19 treatments are now becoming standard of care for COVID-19 patients that have been hospitalised and are saving lives. Bill Anderson, Roche CEO, said that  there are a number of different treatments under development, with “the most potent and most promising [likely to be] oral drugs”.

The biopharmaceutical industry involved in the development of treatments and its suppliers are working on scaling up manufacturing capacity, but their effective roll out to COVID-19 patients is dependent on access planning.

Getting the therapeutic roll out right will be important for all countries to be able to benefit from future innovation, such as the anticipated oral outpatient COVID-19 therapeutic candidates.

I invite you to have a look back at the media briefing and read through the data presented by Airfinity.

As we take in the lessons from the past 18 months, I’m hopeful that our industry will continue to harness the power of innovation, replicate the pace of setting up collaborations to accelerate the speed of R&D to bring solutions for other unmet medical needs. As Belen mentioned, critical tools will be digital and data.