Ensuring the delivery of vaccines in record time

This oped was originally published on in the Down to Earth (16-30 June 2021 Edition).

Scarcity of raw materials and trade barriers could dent hopes for 10 billion vaccines produced by end of 2021

Back in March 2020, vaccine innovator companies started working on how they would set up manufacturing and the supply chains produce their vaccines candidates once they were approved.  One of the reasons for the speed at which the world has been able to produce COVID-19 vaccines in the billions in a matter of months, was the fact that production and supply teams worked in parallel with the scientists in the labs, not knowing yet whether their vaccine would make it to the finishing line  – something that has never been done on such a scale before.

Their efforts are clear to see. At the end of this month, three billion COVID-19 vaccine doses will have been made by the vaccine manufacturing four powerhouses: China, the European Union, the United States and India.  By the end of 2021, it is estimated that over 10 billion doses will have left the production lines.

As part of the manufacturing preparations, the first of today’s 300 collaborations were being drawn very early on.  Today, cooperation is taking place in many parts of the world: in USA, China, EU and India, but also South Africa, India, Brazil, Argentina, Malaysia, Turkey, Thailand, Egypt, Mexico, Indonesia, Iran. Getting collaborations up and running takes time.  Aspen Pharma in South Africa and Johnson & Johnson agreed to work together in November last year for the fill and finish process to put the vaccines into vials.  Aspen plans to have the vials leaving the manufacturing lines at the end of June.

Another early preoccupation involved checking the supplies of raw materials and the equipment needed, as well as finding and training the staff to ensure the smooth running and the necessary quality checks. The numbers are telling.  It takes 280 components to make the Pfizer-BioNTech mRNA vaccine, involving 86 suppliers located in 19 different countries; these materials need to reach three different manufacturing plants, where the vaccines will go through a manufacturing process that involves 50,000 production steps; and at least 70 quality checks.   Now multiply that by the number of vaccines that have been approved.

Collaborations to make vaccines is not easy.  We have seen that even seasoned partners experience difficulties.  Emergent BioSolutions who were helping with the production of J&J vaccines threw away millions of doses, because they did not meet the necessary quality control.

We have been warning since March this year that some crucial raw materials are in short supply.  The late delivery of the bioreactor giant plastic bags can set back production by weeks, delaying the delivery of millions of much needed vaccines. In other cases, there are difficulties in finding the skilled technicians needed to oversee the production and check the quality and safety through the process. In addition, trade barriers are hindering the flow of these goods, the vaccines themselves.  We all recall the heartfelt tweet by Adar Poonawalla of the Serum Institute: calling on @POTUS to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up.

We have been deeply concerned that despite our efforts, COVID-19 vaccines currently are not equally reaching all priority populations worldwide.  We have laid out five steps that urgently need to be addressed.  We are calling for dose sharing. We commit to support by making any uncommitted doses available.  We backed up our words with action within days, with 3,5 billion extra doses pledged by major vaccine manufacturers at the G20 Health Summit in May.

We are committing to continue efforts to optimize production.  The supply situation remains challenging for critical input supplies, such as bioreactor bags, single-use assemblies, cell culture media, filters, lipids, and vials & stoppers.  Vaccine innovators will of course continue to work closely with their suppliers to avoid disruption where they can.  But in the case that suppliers might have stocks that have not yet been tapped for whatever reason, we trust that the COVAX Supply Chain and Manufacturing Task Force can direct its immediate attention on creating a voluntary partnership to improve visibility of the supply of manufacturing input and to facilitate the establishment of global trade processes for the free movement of raw materials, vaccine components, and assay reagents.

We have learnt so much over the past 18 months and we will definitely be learning more as we hope to hit the target production to meet the world’s needs.  For innovative bio-pharmaceutical companies the work is far from over.  We have our work cut out for us.  We continue to prioritize the development of new COVID-19 vaccines, including vaccines effective against new variants, looking for new formulations for easier and longer storage.   For this work to continue, we urge governments to guarantee unhindered access to pathogens of any COVID-19 variants to support the development of new vaccine and treatments.  If this does not run smoothly, it will impact booster development and it will hamper the WHO’s ability to respond to the next seasonal influenza viruses.   In the last couple of days, we have joined the G7 future pandemic preparedness partnership to achieve a moon-shot target of 100 days to develop a vaccine in the case of a future pandemic.  Cutting down from the already historic 326 days to bring a first COVID-19 vaccine.

Antibiotic research leads start-ups to ruin (Taggesspigel)

Original article published on Taggesspigel on 15 June 2021. 

Mr Cueni, of all things, the COVID-19 pandemic, triggered by a virus, could further fuel the development of resistance in bacteria: many Covid 19 patients in hospitals are given antibiotics unnecessarily. G-7 health ministers are warning of a “creeping pandemic” and have been pushing for the development of new drugs for years. At the same time, pharmaceutical companies are saying goodbye to antibiotic research in frustration. How does this fit together?

Mr Cueni: In their analysis, politicians, scientists and industry agree: there is an urgent need for action. If COVID is a tsunami, then antibiotic resistance is a slowly melting glacier. According to the World Health Organisation, antibiotic resistance already kills 700,000 people worldwide every year. If we do nothing, by 2050 there will be ten million – per year. These are avoidable deaths. The keywords for solving the problem are well known: One Health approach, appropriate use, also in agriculture, surveillance, fair access for developing countries. And above all, innovative antibiotics; many of the current ones are no longer effective. Everyone is aware that the problem must be tackled at its root, and that root is: no new antibiotics are coming onto the market because there is simply no market for new antibiotics at the moment and antibiotic research is making start-up companies insolvent.

You are the Director General of the IFPMA, you represent the interests of these companies. Do you feel abandoned by politics?

Mr Cueni: Mutual recriminations are pointless. The German Chancellor was one of the first politicians worldwide to take antibiotic resistance seriously. That deserves recognition. But there is a difference between signing a summit declaration at G7 or G20 and signing a billion-dollar cheque to make antibiotics research profitable again.

The German pharmaceutical market alone achieved a turnover of almost 50 billion euros last year. Let’s be honest: What’s the matter?

Mr Cueni: The market situation for antibiotics is disastrous. In 2019 and 2020 alone, four companies had to file for bankruptcy. They could not continue to exist, even though they had brought new, successful antibiotics to the market and had received their approval, in some cases with priority, from the US Food and Drug Administration (FDA). Achaogen, for example, a start-up company from California, had not even achieved one million dollars in sales with its new antibiotic after 18 months.

How could it come to this?

Mr Cueni: For decades, antibiotics were neither used properly nor carefully in human and veterinary medicine. This has led to resistance. As a consequence, innovative antibiotics are being used today mainly as reserve therapies; they end up in cupboards of hospital pharmacies and are only used in emergencies when nothing else helps. However, these innovations are paid like antibiotics that were developed 30 or 40 years ago and have achieved large volumes over the decades, based on improper use. Thus, a new antibiotic makes very low sales but costs a lot of money in development and research, about 1.5 billion euros.

What makes research so expensive?

Mr Cueni: Developing new active principles is a scientific challenge; the low-hanging fruit has already been harvested. In addition, the regulatory requirements are high. For the clinical trials, you need quite a large number of patients, because the drug has to be tested widely. Company directors tell me that they have to invest in specially equipped factories for the production line in the early phase I of clinical trials. Afterwards, however, these factories stand empty and the manufacturers cannot sell their product because it is only needed as a reserve antibiotic. Companies that research antibiotics today and succeed are worse off than those that fail: because they lose money every day, while the others can at least write off their research costs. All of this is not productive.

What would be productive from your point of view?

Thomas Cueni: You have to decouple incentives from sales. We need to treat antibiotics like a fire extinguisher: everyone has it in the house, but no one hopes to ever need it. Nevertheless, everyone pays their fire insurance.

Are you calling for a premium for antibiotics?

Thomas Cueni: For example. Everyone who goes to hospital, for example because they want to have their knee screened, could pay a supplement of, say, five euros, which would then be used as a premium for antibiotics research. A Netflix model for reserve antibiotics would also be conceivable: One no longer pays per therapeutic dispensed, but rather an annual subscription, so to speak, for the reserve antibiotics, which are only used when needed, i.e. one decouples the price from the amount of antibiotics used. We have seen in research on drugs for rare diseases how strongly incentives can work by granting prices for these drugs that correspond to the rarity of the disease. One could also consider using patent protection as an incentive for research. Even an extension of patent protection from the current 20 to 70 years, however, would not bring much to new antibiotics as long as few are sold. It would be conceivable, however, that for every truly innovative antibiotic, the patent protection of another drug would be extended by six or twelve months. There are so many possibilities.

Admittedly, this means that not a single new antibiotic has been developed yet. And time is pressing.

Mr Cueni: Right. We need more venture capital, and above all we need it quickly. And that is why the industry is not whining but is facing up to its social responsibility and launched the AMR Action Fund a year ago. Twenty-three pharmaceutical companies have committed to providing a total of one billion US dollars as financing bridge for projects of start-up companies that want to make the jump from phase I to phase II and III. The fund management is independent in its decision-making about who gets funded. If the model works, it may be that one or the other start-up will one day find a place with the big players. In this way, we hope to bring two to four new antibiotics to market in the next seven to ten years. That is our contribution. However, this will only be successful and lead to more investment in antibiotics research if politicians have taken the right steps by then, so that antibiotics research can be financed sustainably in the future.

Vaccines against covid-19 could also be developed at a rapid pace because researchers cooperated internationally and building blocks for the innovative mRNA technology had been prepared years before. A model for antibiotics research?

Mr Cueni: The community in this area is clear, and of course it also exchanges information. But what has to be stated objectively is this: The difficult environment in commercial antibiotics research has led to many young people, even though they are fascinated by microbiology, not taking up their studies or changing careers. We are lacking the offspring.

Why?

Mr Cueni: When students see that there is little or nothing going on in their field at the larger research-based pharmaceutical companies, then they know that there will also be no demand for microbiologists. So we also need incentives for studies, we need an environment where, in addition to start-ups, large pharmaceutical companies are still doing research or are doing it again.

MSD, Pfizer and GSK are setting a good example here, because they never dropped out of antibiotics research. It is also gratifying that the company Roche re-entered the early phase of antibiotics research a few years ago and is now also participating in the AMR Fund.

Gradually, politicians and pharmaceutical companies are realising that the most modern cancer research is of little use if the patient develops a secondary infection in the meantime and the antibiotic is no longer effective. That is why, despite the dry analysis of the current situation, I am actually optimistic that something is now moving. Thanks to the leadership of countries like the Federal Republic of Germany and the United Kingdom, there seems to be a growing awareness at the G7 that the COVID 19 pandemic has caught the world on the wrong foot, so it is important to create the right incentives now when it comes to antibiotic resistance. The PASTEUR Act, which is being reintroduced in the US Congress this week, could be a ground-breaking global model in this regard because it contains both monetary incentives for successful investment in research and careful use of new antibiotics.

CNBC TV18: Need over 10 bn doses to vaccinate 60% of world population by March 2022

Talking to CNBC-TV18’s Parikshit Luthra (4 June 2021), IFPMA Director General Thomas Cueni shared his perspective on global vaccine supplies.

Main interview highlights from Thomas Cueni:

We from IFPMA called out to governments across the world to join us in a five-step plan to urgently address vaccine equity. The first ask is dose sharing. There is a shortage of vaccines. We always knew that this was a colossal daunting challenge. I think the only way to address this now is with rich countries starting to dose sharing, rather than start vaccinating healthy school children with low risks.

If we want to optimize vaccine production and scale up output, we need to tackle trade barriers. The Pfizer/BioNtech vaccine for example is composed from 280 different ingredients, coming from 86 different suppliers, passing through 19 countries. Trade barriers are a significant obstacle to scaling up capacity, in addition to the problem that there are scarcities of raw materials. And we know that some companies say that they could manufacture more, but the raw materials are simply not there, and vaccine manufacturing is an extremely complex biological issue.

This year, there were three major vaccine manufacturers – Pfizer/BioNTech, Johnson and Johnson and Moderna – announcing that, over the next 18 months, they do want to supply 3.5 billion doses to low and middle income countries. That’s really something which we need. We do know that there will be scarcity and there will be shortages for the next few months to come, but I believe we are seeing light at the end of the tunnel.

In terms of 2021, we know, and World Bank has published studies on it, that if we do reach the 10 plus billion doses this year, we could vaccinate the 60% of the world’s adult population by March next year. That is an amazing. Against COVID-19 we have the fastest vaccine developed within 326 days, and as of now, less than half a year since the first vaccine was approved, we have six vaccines formally approved by the WHO, with emergency use licensing. We are really seeing an amazing time for science, but we are also still confronted with the challenging task of scaling up vaccine manufacturing further.

The question about how much we need in 2022: I expect that we will continue to see high demand in 2022 because we do have the variants and we don’t know yet how long will the immunity from the vaccinations last. We also expect that we will need the booster shot but: will we need it once per year, twice per year, or only every second year? A lot of these questions will be answered over the next 18 months or so.

The vaccine crunch to some extent was inevitable, and the concern which I’m personally confronted with is that originally there were countries moving really early with procurement, like the United States, the UK but also the European Union, which was a bit of a hatching, because at that time you didn’t know yet which vaccines would work. Now we know. Now we have seen a move from vaccine hatching to vaccine hoarding. Some of the rich countries have six doses per capita, and some of the rich countries are now starting to vaccinate the young and the healthy at a time when, for example, many people in Africa and even healthcare workers haven’t received it.

We do see a tremendous amount of partnerships. We also see tremendous efforts by everybody. I’m truly impressed also to see companies such as Serum Institute of India, Bharat and also Biological E. and the sense of togetherness. We can only defeat the pandemic, if we leave No One Left Behind, and if we do reach that with unprecedented partnerships which quite often also involves technology transfer.

One of the elements, one of the reasons why we responded so fast, is a strong protection of intellectual property, which gave companies the confidence to sign almost 300 partnerships, and more than 200 of them include technology transfer. There’s been a lot of debate about this IP waiver which honestly, is the neat, simple, but wrong answer to the challenge we are faced with of scaling up manufacturing.

 

The global health threat hiding in plain sight should not drop off the G7 agenda (Excerpts)

This oped has been originally published on The Telegraph on 3rd June 2021.

Professor Dame Sally Davies, UK Special Envoy on Antimicrobial Resistance

Thomas Cueni, Director General, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

In 2016, the United States National Security Council[1]drew up a playbook on fighting pandemics so that the next response to an epidemic was better handled than the response to the spread of Ebola. The same year, the G7 put tackling antimicrobial resistance (AMR) on the agenda.

Today, the twin global health security threats of viruses and bacteria are very real.

Every corner of our health system depends on antibiotics. It’s thanks to antibiotics that illnesses such as pneumonia, meningitis and TB are now treatable. They are used for caesarean sections, routine operations such as arthroscopic knee surgery, and cancer chemotherapy.

Worryingly, bacteria mutate, just as viruses do. […]

The question is, how to make sure that one goes from policy papers, dire projections and simulations to action?

In the case of COVID-19, against the odds and in record time, we already have a range of vaccines to protect against the SARS-CoV-2 virus. The speed of the response is thanks to decades of research on vaccine technologies. In contrast, research for new antibiotics that could stave off the worst of AMR has been stuck in the doldrums. And whilst there are exciting signs at the early end of the pipeline, this innovation is primarily happening in small companies without the infrastructure to take a promising product all the way to market.

Between 2018 and 2020, four companies that had brought new antibiotics to market declared bankruptcy or put themselves up for sale, despite having survived the perilous, decade-long process of development and testing to get a new drug approved[2].  To give a boost to the antibiotics pipeline, the AMR Action Fund[3] has been created to develop two to four new antibiotics by 2030, thanks to close to $US 1 billion from pharmaceutical companies, topped up with support from the European Investment Bank and the Wellcome Trust.

To ensure there is a healthy pipeline of antibiotics that keep up with bacteria’s natural evolution to build resistance, we need more than a fund to boost innovation.

[…]

Despite the huge societal costs of AMR, our health care systems are not currently designed to recognise the value of new antibiotics.

We need adapted market-based policy reforms, including reimbursement reform and new ‘pull’ incentives to create market conditions that enable sustainable investment in antibiotic R&D. We need industry to fully recognise the insurance value that antibiotics provide them. We need healthcare systems to pay their ‘fair share’ for innovation. And most of all, we need governments, researchers and life sciences companies to work together, to put patient needs at the forefront.

[…]

In the United States, the PASTEUR Act that is currently before Congress should create a predictable path to rewarding new antibiotics for their value to society via a subscription contract (valued at $750m to $3bn) that prepays for all US federal use of the drug. This would be a delinked pull incentive that is large enough to move the R&D needle, with powerful support for antibiotic stewardship.

More generally, the global community is also moving to take action on AMR – 135 countries have finalised national action plans, but they must be fully funded and implemented.

These are good actions and are pointing us in the right direction.  But, if COVID-19 has taught us something, it is that global health security, as the name implies, needs to be truly global.  As the G7 Health Ministers meet, it is crucial that they give AMR a last push and agree global action to strengthen research and development for new antibiotics, once and for all.  Let us not fall into the trap of tunnel vision and squander the opportunity that we have been building up to over the past seven years, to fix this silent pandemic of AMR, which otherwise could have consequences far more deadly than COVID-19.

 

Overcoming key barriers to quality diabetes care around the world

This oped was originally published on Foresight Global Health on 3rd June 2021.

Innovations in diabetes treatment and management have made enormous contributions to global health over the past 100 years, but there are still obstacles that must be overcome to slow the growth of the disease and reduce its impact.

Exactly a century ago, two researchers at the University of Toronto were credited with discovering a pancreatic extract that could lower peoples’ blood sugar. The insulin treatment they pioneered, and other innovative diabetes medicines, have since saved countless people from suffering or dying from diabetes.

And yet, as we mark this anniversary, effective prevention, treatment, and control of diabetes remains out of reach for many. The burden of diabetes—for individuals, their families, and health systems—is especially acute in low- and middle-income countries, where it is estimated 79 percent of people living with diabetes (PLWD) reside.

The number of people with diabetes has quadrupled in the last 40 years. According to the World Health Organisation (WHO), it is the only major noncommunicable disease for which the risk of dying early is increasing. Today more than 450 million people have one of the several types of the disease, in which the body either can’t make insulin (Type 1) or can’t properly use what it produces (Type 2 and pregnancy-related). As many as 80 to 100 million people, including all of those with Type 1 and some with Type 2 diabetes, need insulin to survive. Among all diabetic patients, failure to prevent, treat or manage the condition can lead to a range of complications, including blindness, kidney failure, heart attack, and lower-limb amputation.

A complex and multifaceted global health issue

Governments, healthcare professionals, life sciences and medical technology companies, and civil society organizations can and should work together to reverse this trend. But how? Yearning for an easy fix, some point to the cost of insulin as the chief barrier to success. It is not that simple. Whilst insulin availability and affordability does indeed represent an important component of managing this multi-faceted disease, PLWD need access to a package of products, services, and support to enable them to achieve affordable, quality diabetes prevention, diagnosis, treatment, and control.

For those who are insulin-dependent, regular blood glucose monitoring and safe administration of insulin can be a major challenge when the consumables required—test strips, lancets, digital readers, and scales—can cost significantly more than insulin itself. A 2015 study from the respected global public health organization PATH found that in Kenya and Senegal, 85% of the cost PLWD pay to manage their diabetes goes to such devices.

Meanwhile, a 2020 PATH survey conducted in Kenya and Ghana demonstrated that markups by middlemen along the supply chain running as high as 288 percent, and frequent product stockouts, significantly increased the cost of care for end users in countries where out-of-pocket payments (and lack of government funding) are still prevalent.

According to research conducted by the IQVIA Institute, across 32 low- and middle-income countries, there is a diverse and growing mix of insulin manufacturers and distributors selling insulin.  The per-day cost of insulin charged by manufacturers is relatively low, ranging from 20 cents for human insulins to ~$1 or more for analogue insulins. The analysis found no correlation between the number of insulin suppliers, market share, pricing, and availability for PLWD.  Clearly there is a complex array of different factors that impact insulin affordability at the point of care.

Collaborating to build integrated care solutions

To address diabetes effectively for PLWD, the global health community needs a joined-up approach—from governments putting in place adequate financing, improved regulatory approval, prescription policies, and enhanced supply chains to collaboration aimed at improving affordable access and building health system capacity for controlling diabetes.  This includes providing healthcare professionals with the tools and training they need, and empowering PLWD with quality information concerning diabetes prevention, treatment, and control.  In this regard, digital health tools can play an important role.

Diagnosis is a necessary first step for enhanced diabetes control. Today half of adults with Type 2 diabetes remain undiagnosed. Patients need to be identified and treated long before they appear at a doctor’s office or hospital suffering from debilitating health impacts.

Another major success factor will be prevention. In addition to the 450 million people who already have diabetes, 350 million have higher than normal blood glucose (so-called “pre-diabetes”), meaning they have an elevated risk of developing the disease.

But there is reason to believe we can slow this trajectory. While the causes of Type 1 diabetes are likely genetic, risk factors for Type 2 diabetes include those that are controllable, such as physical inactivity, stress, and obesity. WHO’s new Global Diabetes Compact will include a focus on these risk factors.

At a policy and advocacy level, we need much greater collaboration. Over the years, many diabetes initiatives have remained siloed from one another, either by country, organization, or disease type. This fragmented approach has made it hard to scale up solutions, including improved supply mechanisms, educational tools for empowering patients and communities, and tools for healthcare professionals to ensure timely diabetes diagnosis and quality care.

The life sciences companies that develop diabetes treatments and other health products have worked over many decades to continuously develop new modalities of treatments and monitoring solutions, and to improve access to care in partnership with credible stakeholders. But they also need to build new alliances across industrial sectors – by reaching out to companies that specialize in medical devices, diagnostic tools, consumer technology, and even transportation and logistics.

Global leaders weigh in

The increased risk of death and suffering from Covid-19 for PLWD has become painfully evident over the past 12 to 18 months. As WHO Director General Tedros Adhanom Ghebreyesus and others recently urged heads of state, “Covid-19 must be the wake-up call for governments to finally step up and invest in [noncommunicable diseases].” The appeal also urged governments to “build back better” by investing in healthy populations and resilient health systems that include NCDs as part of their UHC package.  We fully support this call and hope that the global health community will step up its efforts to explore new funding mechanisms and co-create innovative, multi-stakeholder solutions to provide integrated diabetes prevention, treatment, and control to PLWD.

The 2021 World Health Assembly adopted a Resolution on “Diabetes Prevention and Management, including access to insulin.” The text contains a number of positive proposals aimed at improving quality diabetes prevention, treatment, and care (e.g., health system strengthening, multi-stakeholder collaborations, increased NCDs funding and integrated care initiatives).  At the same time, the resolution missed an opportunity to emphasize the need for WHO and Member States to step up efforts to address diabetes as part of UHC.

We have come a long way in one hundred years. But the global fight against diabetes has to accelerate so that we can prevent, treat, and/or control everyone who is at risk. I personally hope that the recently launched WHO Global Diabetes Compact will fulfil these bold objectives through cross-sectoral and genuine collaboration.

 

COVID-19 is modernising the way we run clinical trials: what will happen next?

This blog was originally published on Media Planet Clinical Trials Campaign on 20 May 2021. 

“The biopharmaceutical industry and regulatory authorities have been working to ensure clinical trials have been progressing in all diseases throughout the global pandemic.

When the COVID-19 pandemic began, most of our focus went to ‘how can my family and I stay safe?’ and ‘will we have medicines and vaccines that will treat or protect us?’ While this was on top of our minds, the biopharmaceutical industry, clinical trialists, regulators and others needed to think about keeping clinical research moving ahead for other diseases, while continuing to supply medicines to patients currently enrolled in clinical trials.

Novel technologies and processes

Lockdowns, stay-at-home recommendations and movement restrictions all had an impact, especially on patient enrolment in new clinical trials and access to existing research sites. Keeping participants safe while maintaining the integrity of clinical trials was a priority.

New technologies have helped improve recruitment of volunteers as well as conduct, monitoring and data capture of clinical trials. Regulators instituted ‘regulatory agilities’ (processes that could be sped up or improved) to keep clinical research going. E-signatures were allowed, provisions for ‘remote/at-home’ patient check-ins and medicine deliveries were made and scientific advice processes were expedited. If not for regulatory agilities, years’ worth of data might have been lost, especially for cancer and dementia trials.

What about the progress that has been made? Most regulatory agilities established have a short life span and will end with the pandemic. Is there a way to keep regulatory agilities that have proved beneficial?

Leverage learnings and opportunities

Clinical trials are designed to deliver outcomes – whether positive or negative. We should continue to modernise and look for methods that deliver results more efficiently and effectively without sacrificing quality, efficacy or safety.

Modernisations in clinical trial science will help us adapt more quickly to external events, like pandemics. It also allows us to design trials that adjust to advancements in medical science, e.g. gene-based therapies and promotes using digital tools to increasingly capture and utilize real-world evidence. More remote/real-time monitoring of trials may reduce costs, improve data quality and reduce our carbon footprint.

We must talk about what is in the best interests of patients and what makes the most sense from a scientific perspective. It won’t be easy, getting everyone to agree on a way forward never is, but best practices are best shared. We must strive to keep the learnings from this pandemic foremost in our minds and explore how they can be applied to the future for global health.

This International Agreement Could Lead To Pandemics Worse Than COVID-19 (Excerpts)

This oped was originally published on International Business Times on 11 April 2021.

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.

Waiving IP rules will not deliver more Covid vaccines

This oped was published on the Financial Times on 25 April 2021

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.

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.

Africa’s Vaccine Manufacturing for Health Security Conference – Our top 5 messages on expanding manufacturing in Africa

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.