Challenges and solutions to scaling-up COVID-19 vaccine manufacturing capacity
On the first anniversary of the Access to COVID-19 Tools Accelerator (ACT Accelerator), high-level representatives – from pharma and biotech trade associations and vaccine manufacturers from both developed and developing countries – met to discuss the challenges of scaling-up vaccine production and ensuring vaccine equity.
Present at the meeting were IFPMA Director General Thomas Cueni, Moderna CEO Stephane Bancel, Roger Connor, President, Vaccines at GSK and Vaccines CEO representative on COVAX, Sai Prasad, Executive Director, Quality Operations, Bharat Biotech, President, Developing Countries Vaccine Manufacturers’ Network (DCVMN), Rajinder Suri, CEO, Developing Countries Vaccine Manufacturers’ Network (DCVMN) and Dr Michelle McMurry-Heath, President and CEO, Biotechnology Innovation Organization (BIO).
On the first anniversary of the ACT-Accelerator, time is of essence to take a stop and look at how far we have come. We must salute the extraordinary effort accomplished by the pharmaceutical industry and partners which developed the first COVID-19 vaccine in less than a year and accomplished the fastest global rollout ever done. In February, a few weeks after WHO approval, doses were delivered to Abidjan and Kigali at the same time as Tokyo. We also need to contemplate the way left to go to put an end to the pandemic, which essentially resides in improving vaccine equity. We cannot afford to leave a stone unturned if we want to vaccinate the world and reach herd immunity by next spring. According to the World Bank, if vaccine capacity objectives are met this year – almost 10 billion doses – the world can be vaccinated. But how do we make sure that boosting manufacturing capacity is a success?
Collaboration and technology transfers
The first lesson we can learn from this fight against COVID-19 is the efficiency which has resulted from the global collaboration that took place. Echoing Roger Connor’s remark, I have never seen such a high level of collaboration across the life sciences industry, with biotech companies, academia and other partners. As Roger said, “it is incredible to see AstraZeneca and Oxford coming together; or companies who are typically very competitive, like Sanofi and GSK, trying to do the right thing”. Also, the work of governments and especially regulators, such as the FDA, EMA and MHRA who have worked hand in hand almost day by day with vaccine manufacturers to speed up the approval process, is equally admirable.
“We have a huge role and responsibility to society to keep moving fast so we stay very close to the virus changes and not five steps behind” said Stephane Bancel, and the industry has demonstrated it is fully committed to partnerships and voluntary licensing – more than 270 manufacturing and production deals have been concluded for COVID-19 vaccines. Of these deals, 214 include various forms of partnership or collaboration that rely on technology transfer. There are early signs that the sharing of know-how of the processes and the technologies used to make the vaccines, as well as training specialist personnel to ensure quality standards throughout the process, are now starting to have an impact on the projected output. As these facilities get up to speed, they are able to produce more vaccines, as well as achieve increasingly better yields. Intellectual property rights have not been a barrier to increasing capacity.
We need to recognize that there are only a handful of manufacturers across the globe who have that expertise at hand, and we need to focus on getting them the materials they need to produce as many doses, as quickly as possible. Vaccines are very complex products with hundreds of components and need to be deliver with the same safety and quality standards, always. Therefore, technology transfers are a matter of trust – trust between the partners but also patient trust: 70% of vaccine manufacturing is about quality control and quality assurance.
“It’s a very complex sector, with complicated science, very complicated manufacturing processes, we have to be very careful to whom we transfer the know-how, in particular because of the imperative of safety and quality”, said Sai Prasad, Executive Director, Quality Operations, Bharat Biotech, President, Developing Countries Vaccine Manufacturers’ Network (DCVMN).
That is why we should not get lost into thinking that intellectual property is the bottleneck. The limiting step is manufacturing know-how and capacity, ability to find skilled workers who can take part in the complex manufacturing process, as well as the raw materials.
Talking about raw materials shortages and supply chains challenges, Rajinder Suri, Chief Executive Officer, Developing Countries Vaccine Manufacturers’ Network (DCVMN) said “If a company is manufacturing 1 billion doses a year or it has a potential to manufacture 1 billion doses, and you do not supply the material for one month, 100 million doses are gone. And these 100 million can have a tremendous impact on maybe 100 countries. So, that is the kind of impact that we are talking about and that is why it is all the more important that this should be addressed very quickly”.
Vaccine supply chains are international. The BioNTech/Pfizer vaccine contains 280 ingredients sourced from 19 countries. Moderna’s, AstraZeneca’s, and Johnson & Johnson’s are similarly complex. Export controls threaten these supply chains. This is a recurring concern we have heard from those present at the briefing.
COVAX manufacturing task force
We need to give a round of applause to COVAX for ensuring collaboration between global organizations towards one common goal. In that, COVAX is a real step forward, compared to previous global public health crises.
“Getting vaccines to everyone across the globe is a public health and humanitarian imperative but we need to do it in a way that doesn’t jeopardize the fragile partnerships, and manufacturing relationships that have already been established” said Michelle McMurry-Heath. Indeed, COVAX, if supported by governments, can be the catalyst for efficient vaccine distribution. The recently announced COVAX manufacturing task force would be the appropriate forum for vaccine makers to share their experience of technology transfer and contribute to exploring the skills set needed to build a platform for sustainable vaccine manufacturing.
Our sole focus remains to deliver as many vaccines as we can, and collaboration is our way out to get past this pandemic and prepare for the next one. I’m left with the words of my fellow panellists – that we need to stay five steps ahead of the virus, meaning we need all hands on deck.