Imagine if China had refused to share Covid-19’s genetic sequences with other countries. Vaccine development would have been delayed indefinitely. Monitoring the virus would have been next to impossible.
Thankfully, that didn’t happen. Chinese scientists shared the full SARS-CoV-2 sequence on Jan. 10, 2020, thus kickstarting the development of multiple vaccines created in record time. But such a nightmarish alternative scenario is not farfetched.
Preventing nations from abusing the Nagoya Protocol will require another binding international agreement — one that specifically obliges countries to share pathogens in a timely manner, which would undoubtedly benefit society as a whole.
Thankfully, the member states of the World Health Organization have a chance to enact such reforms through the International Health Regulations, a legally binding international instrument currently under revision, or through the recently proposed international treaty on pandemics.
Consider the Middle East Respiratory Syndrome (MERS), a coronavirus that emerged in Saudi Arabia in 2012. Shortly after the virus’ appearance, Mohammed Ali Zaki, an Egyptian microbiologist based in Saudi Arabia, began investigating the illness. He sent a sample of the virus to a Dutch lab.
Instead of supporting this effort to better understand the virus, however, the Saudi government tried to block the sharing of the virus by appealing to its rights under the Convention on Biological Diversity. And the government’s refusal to share samples of the virus hampered the effort to control the outbreak. To this day, no vaccine against MERS exists.
As currently written, the Nagoya Protocol makes it highly likely that such an episode will occur again.
Obliging countries to immediately share pathogens with pandemic potential would exempt pathogens from national legislation around Nagoya and ensure international cooperation during future pandemics. It would also help the international community make sure that no country is ever rewarded for allowing a deadly disease to spread around the world unchecked.
1998, 39 pharmaceutical companies sued Nelson Mandela’s South African government to stop legislation that allowed pharmacists to substitute generic HIV/Aids drugs for brand-name ones.
It was one of the dumbest things the industry ever did. What started as a legal battle became a human disaster, and a public relations debacle. Critics accused drug companies of valuing patents and profits more than patients’ lives.
The Covid-19 pandemic has been very different. Multiple vaccines have been developed in record time. There has been no price gouging of vaccines and treatments, unlike what occurred with face masks and personal protective equipment. Companies have also worked to ensure equitable access. In February, weeks after WHO approval, doses were delivered to Abidjan and Kigali at the same time as Tokyo.
Yet, we cannot deliver the billions of vaccine doses needed around the world if we fail to increase manufacturing capacity. Before Covid-19, annual global vaccine production, including seasonal flu shots, totalled 5bn doses. During the pandemic, vaccine manufacturers have continue to produce those, but are adding new capacity to make more than 10bn Covid-19 shots.
The challenge of scaling up manufacturing was foreseen as early as March 2020, when industry leaders knew they would need partnerships to increase capacity. Since then, they have screened hundreds of companies around the globe to find the best fits for their needs, and overhauled their supply chains to source components.
Their efforts are paying off. So far, manufacturers have produced 1.3bn vaccine doses. If all goes well they could make 10bn this year, enough to achieve global equity in vaccine distribution and attain worldwide herd immunity by March 2022, according to the World Bank.
But challenges remain. 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. The US government is currently blocking companies from shipping 37 critical items, including adjuvants — an ingredient that helps the immune system create antibodies — to nations like India, where many vaccine manufacturing plants are located. Adar Poonawalla, CEO of the Serum Institute of India, recently implored President Joe Biden “to lift the embargo of raw material exports out of the US so that vaccine production can ramp up”.
Greater visibility in the supply chain, would help avert bottlenecks. A breakdown in the supply of bioreactor plastic bags, for example, can set back output by weeks or even months.
The pharmaceutical industry has learnt the lessons of the Aids crisis, when it took years for drugs to reach sub-Saharan Africa. Vaccine production and distribution has grown rapidly, thanks to numerous manufacturing partnerships. Rather than impede collaborations and technology transfers, IP protection gave companies the confidence to work together.
The way out of this pandemic is to increase vaccine production as fast as possible. Dismantling IP protections would distract from that vital task.
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.
On April 12 and 13 the African Union and the African CDC organized Africa’s Vaccine Manufacturing for Health Security virtual conference, opened by HE Moussa Faki Mahamat, Chairperson of the African Union Commission and chaired by HE Félix Antoine Tshilombo Tshisekedi, Chair of the African Union and President of the Democratic Republic of Congo. Over the course of the two-day program, nearly 90 speakers, and over 40,000 cumulative attendees joined various platforms from over 100 countries. The event concluded with two major partnership announcements with the African Union in support of strengthening vaccine manufacturing initiatives in Africa. Thomas Cueni, IFPMA’ Director General represented the research-based pharmaceutical industry on the panel on intellectual property transfer.
So what 5 messages did we share from the event?
Pharma’s role so far
The pharmaceutical response to the unprecedented COVID-19 challenge has been truly unprecedented. After developing several vaccines in record times, vaccine makers both in the developing and developed world did not lose any time in getting the manufacturing capacity up and running to make more vaccines doses than the world has ever produced before. They have done so by further developing technologies that have been researched for years and agreeing upon collaborations and investments in record time to start expanding manufacturing.
Whilst there has been unprecedented progress there is still much to do, and unfortunately COVID-19 is not going to go away any time soon. We have seen far too many lives lost and livelihoods destroyed to ease up on the fight now. Africa is key to achieving global herd immunity and as stated several times during the conference, more efficient vaccine manufacturing capacities would benefit the struggle against other diseases on the continent as well.
IP is not the issue
Intellectual property protections are not an obstacle to vaccine production. To the contrary, IP has been the engine that has fueled groundbreaking research and development efforts and has enabled broad collaboration amongst a diverse group of stakeholders including governments, research institutions, and pharmaceutical companies. Thomas emphasized that he is often asked if IP is stopping technology transfer. To the contrary, IP has allowed industry to develop necessary vaccine platforms and in the past year for COVID alone, entered into 272 deals of which 204 are based on tech. He also indicated that there have been bumps on the road as vaccine manufacturing is a complex biological process. None of the problems are IP related but related to scale up issues. Thomas concluded with saying that a TRIPS waiver would bring no practical solutions for manufacturing vaccines in Africa.
A stronger regulatory environment will spur investment
The conference also highlighted the need for greater regional harmonization which could help enable exports and expand market potential.
On the regulatory point it is worth noting that there is no globally harmonized set of requirements for a manufacturer to register a vaccine in a new country. As a result, a company may have to prepare up to 140 different registration dossiers. This is why IFPMA and many stakeholders in global health involved in increasing access to medicines and vaccines call for rapid ratification of the Africa Medical Agency Treaty. Numerous participants at the event both public and private echoed these calls for ratification.
The launch of the African Continental Free Trade Area and other harmonization efforts by the African Medicines Agency and various regional organizations are steps in the right direction but building a stronger environment for investment will require a long-term approach and there will be a need to continue work on this front after COVID-19. Mr Solomon Quaynor Vice President, Private Sector, Infrastructure and Industrialization, African Development Bank Group, Côte d’Ivoire stated that these efforts will simplify local African manufacturing and technology and R&D transfers, allowing the emergence of more partnerships.
Financing is key
There needs to be a multi-stakeholder approach, which in addition to the private sector, will include global financial institutions, governments, donors, etc. that can help derisk investments and provide a more long-term approach.
There needs to be a multi-stakeholder approach, which in addition to the private sector, will include global financial institutions, governments, and donors that can help derisk investments and provide a more long-term approach.
Public–private partnerships and joint ventures should also be encouraged and other nontraditional financing methods should also be explored.
Skills development is required
Vaccine manufacturing requires a significant number of technical skills including technical knowledge of regulatory affairs and quality assurance. As noted during the conference, by Stéphane Bancel, Moderna CEO, one of the biggest challenges we are facing today is that human resources are running flat out and perhaps we are pushing our teams too far.
That is why it is important to invest now in the development of these skills locally in Arica. COVID-19 has galvanized the development of indigenous innovations: innovators on the continent have responded with a wide range of creative inventions suited to address local challenges.
This is why, via our IFPMA Africa Young Innovators Health Award, we provide young African entrepreneurs in the healthcare sector an opportunity to develop their business ideas and advance promising solutions. We want to invest in the human capital of Africa’s promising young entrepreneurs. We are looking forward to support the award winners with financial resources, as well as business mentorship and expert support, and advice on intellectual protection.
This is a marathon not a sprint
The African Union announced that the goal would be to manufacture vaccines at five research centers to be built on the continent within the next 15 years and South African President Cyril Ramaphosa said the medium-term strategy should be to expand existing manufacturing facilities into regional hubs.
The Coalition for Epidemic Preparedness Innovations (CEPI) and the African Union Commission has announced the signing of a Memorandum of Understanding, which aims to strengthen ties between the organizations and the Africa CDC to enhance vaccine R&D and manufacturing in Africa.
It also makes sense to develop a pan-Africa vaccine manufacturing capacity strategy that will set the continent on course to build an African resilient knowledge based pharmaceutical industry over the medium term. These are not new ideas, but need a renewed focus now, given the situation we are in.
The virtual conference was a powerful and passionate call for action at African level. Like many, we hope at IFPMA, that this will lead not only towards sustainable local production but to overall major political commitment and major investment for health security and health systems on the Continent.
I am honored to have been invited to speak on behalf of the innovative pharmaceutical industry at the launch of the new Global Diabetes Compact on 14 April 2021.
The Global Diabetes Compact is being launched at an important time in history of diabetes. 100 years ago, the discovery of insulin in 1921 kicked off a century of medical progress that has fundamentally improved the lives of people living with (or at high risk of developing) diabetes. I am proud of our industry’s innovations that include the introduction of human insulin in the 1980s, first-generation analogue insulins in the late 1990s, new generation insulins in the 2010s that bring improved convenience while countering some short-term complications, and new classes of therapeutics that improve glucose control and have other beneficial effects. Leading innovative biopharmaceutical companies have collaborated with partners around the world over many decades to improve diagnosis and insulin delivery, strengthen supply chains, support healthcare professional training and patient empowerment, improve treatment adherence and introduce digital tools to improve diabetes control. (Check out Global Health Progress collaborations here).
But as the worldwide prevalence of diabetes continues to grow, we know there is much more to be done to ensure access to quality diabetes care for all who need it. People living with diabetes, or those at risk of developing diabetes need to be able to get help, in the shape of a package of products, services and support. They need to be able to access affordable, quality diabetes prevention, diagnosis treatment and control. That is why our partnerships in supporting health systems are important in reaching more people living with diabetes. Our industry is committed to scaling up existing initiatives and exploring new collaborative models, in partnership with WHO, governments, civil society, health system stakeholders and other industrial sectors. I am optimistic that the the Global Diabetes Compact will prove to be an important first step towards transforming the lives of people living with diabetes or at risk of developing diabetes. The innovative biopharmaceutical industry is looking forward to supporting the Compact in this endeavour.
On 9 April 2021, I participated in very lively debate hosted by Intelligence Squared, and moderated by John Donvan, Putlizer Prize Finalist and America’s best recognized moderator of live event debate and four-time Emmy Award winner. I agreed to disagree with Brook Baker, Professor of Law, Northeastern University School of Law on the future of vaccine patents.
More than one year into the COVID-19 pandemic, it is clear that this global health crisis has impacted the lives and livelihoods of millions of people across the globe beyond all recognition. Now, as we consider the role played by the biopharmaceutical industry in combating this public health crisis, we must not lose sight of the people who have lost their lives.
Expertise, innovation, and resources
When the virus was first shared, few would have believed possible having not one, but several safe and highly effective vaccines available after less than a year. Few would have also hoped to be witnessing an unprecedented delivery of approved COVID-19 vaccines doses to countries all over the globe. And now, thanks to concerted actions and solidarity, over 100 economies have received them.
We must acknowledge the fact that today, in these unprecedented times, innovation has brought us multiple vaccines in record time, and they are more effective than anyone could have hoped for. This has been achieved thanks to historic collaborations between academics, biotechs, big pharma, developing world vaccine makers, and suppliers, all coming together to make the almost-impossible happen. To make the world feel safer.
This kind of collaboration has also been fundamental to scale up vaccine manufacturing. In pre-COVID-19 times, the total capacity for producing vaccines was 5 billion doses for all vaccines. These include flu, polio, hepatitis, measles, shingles. Now, for COVID-19 vaccines alone, manufacturers have scaled up new capacity from zero to 10 billion doses. In a matter of months, not years, we are looking to double the world vaccine capacity. And to meet this goal, in the past year alone, our member companies have established more than 260 manufacturing and production deals for COVID-19 vaccines around the globe.
Bumps along the road should not surprise us, both in the manufacturing process itself as well as strains on the whole supply chain. Producing a vaccine does not entail simply pushing a button. Therefore, such a complex process will inevitably lead to bottlenecks that will however be urgently addressed and handled.
Collaboration to get us through
In a deadly pandemic, time is never on our side. We are at war against a virus, who, if uncontrolled, can continue to undo hard-won progress in global health and in making lives healthier. In a deadly pandemic, no one is safe until everyone is. Thanks to decades of investments in science and R&D, we’ve been able to mount a fast response against the virus and working with others has helped deploy essential tools in record time.
This couldn’t have been done without innovation enablers.
These are the key points that I shared in a very lively debate hosted by Intelligence Squared, which I invite you to listen here.
Increasing manufacturing capacity for COVID-19 vaccines is one of the biggest challenges we need to address in our common goal to bring this pandemic to an end.
Science has delivered not one but several vaccines that are safe and effective and the goal is ensure fair and equitable delivery to vaccines to those who most need them across the world. However, a worldwide scale up in production is not simple and vaccine technology is highly complex.
I had the opportunity recently to participate at the Africa Health Agenda International Conference during the plenary session “Build Back Better – Health Security Beyond COVID 19”. Seen as key to the future health security for the Continent is increasing local manufacturing capacity in Africa. As a panel we discussed the multiple barriers to quickly ramping up production to meet pandemics including issues relating to the speciality of vaccine manufacturing sites, specific skills needs, needs for incentives for investment, and unknowns around long-term demand for COVID-19 vaccines.
Technology transfer is clearly part of the solution – and R&D pharmaceutical companies have already engaged in the process of transferring know-how for production to local manufacturers in developing countries. Collaborations are taking place on a significant scale. Examples include licensing and tech transfer agreements between AstraZeneca with the Serum Institute in India and Fiocruz in Brazil and between Johnson & Johnson with Aspen Pharmacare Ltd. in South Africa and Biologic E. Ltd. in India.
However, knowledge transfer alone will not solve the problem. Technology transfer cannot operate in a vacuum. What is needed is an established sustainable eco-system for local vaccine production. Many challenges to creating such an eco-system are the same as those that the Continent has faced in advancing local production for small molecules. But three specific issues need to be emphasized in case of vaccine manufacturing:
Firstly, the need for highly specialised equipment. Vaccine manufacturing is a complex process requiring high performance equipment for each stage and for each type of vaccine, that meet strict quality standards. Not forgetting that production sites also need to acquire the necessary GMP standards. What’s more, is not possible to simply repurpose an existing production line, each vaccine requires its own line. This means that should a country have an existing vaccine manufacturing capacity, it does not necessarily mean it can easily retrofit a plant to produce COVID-19 vaccines. Furthermore, in current pandemic situation scaling up the number of manufacturers would not resolve the global shortages of 100 plus raw materials that are needed to make the vaccines and it might just exacerbate these shortages as well as those of vials, syringes and stoppers, etc.
Secondly, the need for skills and human resources. There are also issues around securing a highly trained workforce. Building teams of highly skilled technicians that can interpret the technology transfer, perform the multiple quality checks, keep the machines and production running at maximum yields, takes time, which is unfortunately something that the pandemic does not afford us. As Sai Prasad, President of the DCMVN said recently: “It’s a constant race to have more expertise. And we can never have enough. […] When we are talking about increasing capacities and expertise, it is a futuristic concept, maybe we should think about building it in the years to come. But you know, during 2021, and maybe early 2022, we need to go to where the existing capacities and our existing expertise is”.
Thirdly, creating the right investment environment. Regarding the investment needed to create vaccine production, large amounts of capital are required upfront. However, at the moment there are not enough incentives for investors because of uncertainty around long-term sustainability, policy incoherence between countries and within countries and a lack of common regulatory frameworks. What’s more, vaccines are often produced in large quantities at low prices, creating the necessity of large markets to encourage investment. Therefore, it would be necessary for Africa to take a regional approach to ensure vaccine production was viable. The challenge is exemplified by previous experience. In 2005, the World Health Organization supported the expansion of production capacity for seasonal flu vaccines in 14 countries, including Egypt and South Africa. But the high cost of production relative to demand has meant that many of those plants have shut down since then. This is why it is important to look at the sustainability of investments, to not end up with a lot of dormant sites.
Overall there is a critical need for prioritization of the African national health systems themselves, including investing between 5% of GDP and 15% of public expenditure in health. Government coherence that promotes innovation and developing more skilled manufacturing and innovative workforce will be equally important.
Identifying a pathway forward
There have been some significant recent signs of progress which can help towards creating a positive eco-system on the Continent. These include significant improvements in regional regulatory harmonization, the implementation of an African Continental Free Trade Area, the African Development Bank support for purchasing vaccines for the African Union and the exceptional leadership demonstrated by the African CDC in the COVID-19 response. Hopefully the soon to be established African Medicines Agency will add a further important milestone.
The challenges to broad vaccine manufacturing and potential solutions will be discussed further during the African Union’s upcoming virtual conference, which will focus on creating road map for the continent.
Africa remains key to solving the global pandemic. In the short term, we need to see COVAX rolling out its doses as countries are ready and are able to confirm they are ready to do so. In the medium term activities such as “fill and finish” for vaccines provides an important option for African industry which can be developed further. In the longer term, to increase vaccine manufacturing capacity across Africa, we need to spare no time in developing viable strategy now to put in place a secure and sustainable eco-system for vaccine manufacturing in order to address future pandemics.
2020 witnessed a decade of scientific progress compressed into just 12 months. And as a result we now have, ahead of all predictions, a number of C-19 vaccines that can protect the heroic healthcare workers, the elderly and the vulnerable; and hopefully society as a whole as long as we can keep the mutations in check. We also have treatments that are helping many more by saving lives of people who contracted the coronavirus. I am gladdened to see how my peers across the biopharmaceutical industry have contributed to the global efforts in society’s hour of need. Many companies forged new collaborations to develop COVID-19 diagnostics, treatments and vaccines, while at the same time making sure patients suffering from other conditions continued to receive their treatments. It has not been plain sailing – some companies have seen the risks they have taken rewarded with highly effective and totally new vaccine technology, others have gone back to the drawing board, or even abandoned. But that’s the nature of our business, taking risks in the hope that we can make a difference to people’s lives.
Tough months maybe years of an “unstable crisis” lie ahead
The challenges ahead are many-fold; not least to make sure that COVID-19 solutions are distributed equitably. In such a febrile environment where our politicians and institutions are under pressure like never before, we need to show our business model has a social business mindset in addition to a financial mindset.
Environmental, Social and Governance drives positive and purposeful action
We have our work cut out for us, as an industry and therefore for IFPMA too. But as the Chinese word for crisis also means opportunity: there has never been a time when the economic and financial damage of ignoring public health have been starker. Now investors as well as politicians and policy makers are looking at us, the biopharmaceutical industry needs to show how it meets the Environmental, Social and Governance (ESG) criteria. We need to demonstrate the contribution we make to access to medicine and health for all, and that these are key factors to support economic growth and stability.
An IFPMA strategy in sync with our business and patients today and in the future
IFPMA has an important role to play here – to inform and explain how the biopharmaceutical business model can integrate availability & accessibility while still striving to push the barriers of science to offer hope and better lives for people wherever they live. But this on its own is not sufficient, not least because, if COVID-19 has taught us one thing – it is that we are all in this together. IFPMA is in a privileged position to listen and co-create solutions to societies’ global health challenges. It can create platforms for key stakeholders to engage with our industry. It can be a force for change by co-creating sustainable solutions to strengthen health systems and address global health challenges in particular pandemic preparedness. IFPMA has already gotten off to a great start in this area with the creation of the Access Accelerated, and more recently the AMR Action Fund.
Responsibility, ethics and sustainability at the heart of the business model
I look forwards as the incoming IFPMA President to help IFPMA steer this course. I intend to work to ensure that “ethics” and “sustainability” is at the centre of our work. Ethics without living up to our values, we will lose the trust of patients and healthcare professionals, without which our innovations will serve no purpose. Sustainability in terms of our contribution to the sustainable development goals (SDGs), and more specifically the health SDGs such as Universal Health Coverage and contributing to strengthening health systems who need a “shot in the arm” to get back on track to meet the needs of patients. But also, sustainability in terms of how financial markets look at the viability of our balance sheets and our governance systems, as well as our contribution to society and our environmental footprint.
Whilst we are still in the midst of COVID-19, the worst pandemic since 1918 which is affecting every part of our lives, we can draw some lessons that will allow us to be better prepared for the future.
The first lesson of the pandemic is the importance of translational research; applying basic science and research into scalable solutions for patients. Known for almost 20 years, with the Pfizer/BioNTech and Moderna vaccines, we have witnessed the first successful application of mRNA to vaccines.
Drawing on decades of scientific research into vaccine science and technology, and experience in fighting other outbreaks such as SARS and Ebola, we have compressed a decade of normal development times into just ten months.
Today, we have several vaccines already approved and in use, with more on the way. This is a remarkable achievement. The evolution of the virus is a stark reminder that we will have to adjust our scientific approaches. So continued innovation will be key.
Importance of a common system
During the past months, we have also realised the critical role that diagnostics play to identify, slow and prevent the spread of viruses. The lesson here it that we need to continue to invest into the development of accurate, fast diagnostics that can also be produced in large volumes.
The swift, timely and unrestricted pathogen sharing has proven to be critical in this crisis. To prepare for future pandemics, we must remove bilateral barriers to accessing pathogen samples and agree on a common system.
Equally, we need to share best regulatory practice and harmonise in more efficient approaches; this is inclusive of clinical trials, testing and approving efficacious, quality vaccines. Such regulatory convergence does not mean cutting corners, it is setting gold standards.
A collaborative mindset is key
The real heroes of this pandemic have been the healthcare workers, be it in ICUs or those involved in testing and vaccinating entire communities. Resilient primary healthcare systems with qualified personnel are the best defence against the spread of infectious diseases.
To control the spread of diseases we need to invest in healthcare infrastructures and frontline health workers so that we will be better equipped to contain unpredictable outbreaks and deliver life-saving tools.
Last but not least, we have seen the importance of partnering; not just partnerships in R&D or manufacturing, but also partnerships in deployment. Governments, health organisations, scientists, businesses, civil society and philanthropists are collaborating like never before. If we want to be better prepared for future crises, we need to retain this collaborative mindset.
A summit was convened in a matter of weeks by Chatham House, in collaboration with COVAX, IFPMA, DCVMN, and BIO, took place on 8-9 March 2021. A discussion document helped inform participants, gave an overview of the current COVID-19 vaccine manufacturing supply chain and identified emerging challenges. While the meeting was conducted under Chatham House rule to facilitate an open discussion, a media briefing followed the summit gave a readout of the key topics discussed. In addition, two key speakers at the event, the new DG of the WTO, Dr Okonjo-Iweala and Secretary of State Matt Hancock of Great Britain published their statements.
A year since the WHO declared the outbreak of the novel coronavirus as a pandemic, we are deeply aware that we are not only in a war against the virus, but also in a war against time: we know that no one is safe until everyone is safe.
We have reason to look back and feel proud of the valiant efforts made over the past twelve months to ensure science delivers. This has been achieved through unprecedented partnership between and across the private sector from industrialized and developing countries, international organizations, philanthropists, governments, academia and civil society. We’ve seen a game-changing breakthrough for a new technology – mRNA vaccines; more than half a dozen safe and highly effective vaccines developed in record time and already administered to hundreds of million people around the world, and light at the end of the tunnel to retrieve us from pandemic fatigue.
The unprecedented scaling up of vaccine manufacturing, from zero to billions of doses in record time, has led to shortages that are impacting the entire vaccine supply chain. To put the challenge in perspective: pre-COVID-19 global vaccine manufacturing capacity was 3.5 billion doses per year, 5 billion if seasonal flu shots are included. This year, for COVID-19 alone, we talk about a capacity of almost 10 billion, likely to be higher if booster shots to deal with new variants are added.
We should not be surprised that this scale up of biological processes has its difficulties and there will be bumps along the road. Not least, because when scaling up exponentially the number of doses, it put a huge strain on the productive and yields produced by the new manufacturing lines put in place for these new vaccines. More than doubling of worldwide annual vaccine production puts a huge strain on the hundreds of raw materials and components such as lipid nanoparticles for the mRNA vaccines, the adjuvants to boost the vaccines, the giant plastic bags for single use bioreactors, glass vials, or the single use filters. These strains on the whole manufacturing supply chain can be further challenged by scarcity of expert technicians, by scarcity of materials, compounded by the interdependencies of materials needed for other biologicals, vaccines or cancer drugs.
We see the impatience of people and governments around the world who are eager to get their COVID-19 jab today and not tomorrow. The summit was an opportunity to discuss bottlenecks that we need to tackle urgently to expand manufacturing capacity. During the 2-day event, I saw the willingness of everyone involved to leave no stone untouched. Manufacturers, suppliers, international organisations, regulators, governments, are working together in a new and creative way, and I’m confident we will see new players coming in with their manufacturing know-how and capacities. Going forwards, we will be eager to explore what we can do to address the areas identified as needing action:
Free flow of goods and workforce;
Continue technology transfer and manufacturing partnerships between innovators and manufacturers to scale up and scale out COVID19 vaccine capacity;
Better demand forecasting and inventory management of raw materials and critical consumables;
Support from the highest political level is needed;
Value of regulatory harmonization and streamlining to accelerate manufacturing capacity and supply;
Better production, demand and supply, forecast and visibility;
Give consideration to the potential impacts of COVID-19 production on non-COVID products.
We will be unstinting in our efforts as the goal is clear for all: we need to expand capacity and in a way that promotes equitable access and leaves no one behind.