Views from a vaccine manufacturer: Q&A - Abdul Muktadir, Incepta Pharmaceuticals; Pandemic Treaty Action

Newsletter Edition #43 [The Weekly Primer]

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Hi,

Far away from Geneva, some developing countries are vying to become the next big vaccine manufacturing powerhouse. With India facing surging infections caused by SARS-CoV-2 and its variants, the pressure on Indian manufacturers to retain vaccine doses for India and the neighborhood will only increase, notwithstanding contractual commitments with Western manufacturers, and of course, the obligations towards the COVAX facility.

Unfortunately, this scramble needn’t have been so. Activists and a few developing countries, have been crying hoarse that the base of production capacity must quickly expand to capable manufacturers in the developing world. We have been told that there is some resistance to even map manufacturing potential and capacity available in emerging economies. (Of the 576 million vaccine doses administered so far, 76% have gone to only 10 countries, most of them high income countries.)

To understand the views of manufacturers in the developing world, we reached out to Bangladeshi pharma major, Incepta Pharmaceuticals. This week we bring you an exclusive interview with Abdul Muktadir, who leads the company.

We hope you enjoy reading this curated edition.

Note that we have made public, our exclusive story from last week, a comprehensive analysis: Examining the motivations for a pandemic treaty. Let us know what you think.

If you needed another reason to subscribe to Geneva Health Files, this is it! Earlier today, WHO announced a proposal for an international pandemic treaty. So our story was just in time, to help our readers understand the motivations driving these discussions on the treaty. We have you covered on this behind-the-scenes action.

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I. THE GENEVA HEALTH FILES INTERVIEW

As we reported recently, the debate around enabling technology transfer is proving to be critical in addressing shortages in the production of vaccines to fight back the pandemic. We wanted to know from manufacturers from developing countries on the challenges they face in making vaccines for COVID-19. Geneva Health Files brings you an interview with Abdul Muktadir, Chairman & Managing Director, of the Dhaka-based company Incepta Pharmaceuticals Limited.

Muktadir, an industrial pharmacist by training, leads Incepta, which was established in 1999. A company specialising in biosimilars and vaccines, Incepta employs nearly 10,000 people and produces about 1000 different medicines and vaccines including oral cholera vaccines, vaccines for influenza, measles, rubella, and Hepatitis B among others. Incepta exports to 67 countries across the world, has three manufacturing sites, and has 17 factories and research facilities.

Abdul Muktadir, Chairman & Managing Director, Incepta Pharmaceuticals Limited

[Geneva Health Files]: What according to you, are the real impediments for technology transfer in the process of production of vaccines in the developing world? 

[Abdul Muktadir]: The innovator companies are preoccupied with the supply commitments to the governments from where they have taken advance payment. They have successfully transferred the technology to all the Contract Research Organizations (CROs) so the technical difficulties that are often referred may not be a big impediment. The innovator companies are at ease working within their comfort zone and do not want to deal with unknown companies.

This is the real barrier that the innovator companies do not feel comfortable working with many companies from developing world.

[GHF]: In policy debates in Geneva, developed countries argue that intellectual property has not been a barrier for the production of vaccines. What are your thoughts on this? 

[AM] In current context the IP right is not the impediment as the companies from the developing world would act either as a CRO or as a license holder. The innovator companies should utilize as many manufacturing bases as possible and then increase their production. In this case there is no issue of IP violation.  

[GHF] It has also been argued that manufacturers from developing countries may not have the skills and equipment to engage in technology transfer. What are your views on the expertise and manufacturing capacities in the developing world?

[AM] There are several technological platforms for production of currently approved COVID-19 vaccines and for each platform there are differences in upstream and downstream processes. The vaccine manufacturing is not very widely distributed but the companies who manufacture vaccines they understand the process fairly well.

So, the capacity and expertise are available with the manufacturers of the developing world otherwise Serum Institute and other Indian manufacturers would have faced difficulties. The equipment might require some re-tooling to accommodate the new process but certainly it is possible. 

[GHF]: As a developing country manufacturer, what in your view is a preferred way for technology transfer: non-exclusive licensing or bilateral arrangements? And why?

[AM] Here, the primary objective is to increase the volume of production. My argument is: if a company can deliver 1 billion doses a year then we should try to increase that capacity to 4 billion using the same principle. No company was prepared to deliver 1 billion doses a year but the companies are doing this now. The task of manufacturing should be distributed based on the capability of each manufacturing partner.

The best way should be to mass manufacture antigen [vaccine active ingredient] bulk in a few places and then the antigen could be distributed for fill/finish wherever the capacity is available. 

We are referring to any licensed Covid-19 vaccine such as Moderna, Pfizer, Astrazeneca, Johnson & Johnson. If we receive the active bulk ingredient, we have the capacity to fill and finish.

This way we can involve many companies in many different countries. This would also eliminate impediments on cross border transportation. We observe now that most of the manufacturing countries are putting barriers in previously agreed supply commitments. 

The above process would involve both non-exclusive licensing and bi-lateral arrangements. We can avoid non-exclusive licencing if the innovator company can make it through multi-party contract manufacturing. In such a case the technology transfer requirement would be as per the requirement of each task. If the bulk antigen can be produced in few places then the requirement of tech transfer would be very minimum and the innovator company’s technology can remain very well guarded.

The current technology of manufacturing the COVID-19 vaccine is probably known to many vaccine companies including companies from the developing world like ours. The biggest challenge in introducing a new vaccine is to successfully conduct an efficacious clinical trial and this remains the main barrier for a new vaccine. So, our best option would be to manufacture the already approved vaccine in massive scale and providing them fair reward for their innovation.

[GHF] Can you share specific details on your operations in Bangladesh in terms of capacity for technology transfer? What would be the easiest vaccines to produce and what are the potential areas for improvements in your manufacturing plants.

[AM] We have full scale vaccine and biosimilar manufacturing facilities. We can manufacture bulk antigen using almost all technology platforms.

We have the bulk antigen production facilities which could be utilized to adapt almost all technology platforms (e.g. mRNA, DNA, adenoviral & insect/baculoviral etc ) available for COVID-19 vaccine. 

For example, we have developed a meningococcal polysaccharide subunit vaccine (ACYW135), hepatitis B sub-unit vaccine (Virus Like Particles VLP-based)  and whole cell oral cholera vaccine from our own bulk, and obtained licensure for these vaccines in Bangladesh. Moreover, a cell culture-derived rabies vaccine that we developed is in clinical trial now. A pre-clinical study for typhoid conjugate vaccine is on-going. In addition, we have more vaccines in the pipelines.

Depending on a particular process we have to re-tool the facility to accommodate the manufacturing of a new vaccine. Once we have a process in hand, then we would know the extent of re-tooling requirements. Once the facility is ready then we have to optimize the manufacturing process and it requires some time.

For us the easiest COVID vaccine technologies  would be the protein subunit vaccines [ such as the one produced by Novavax] and mRNA vaccines [such as those produced by Pfizer/BioNTech and Moderna. We would also be able to manufacture adenovirus vaccine.

We have the bulk antigen production facilities which could be used to adapt technology related to mRNA vaccines and protein subunit vaccines for COVID-19. 

We have a 500L bioreactor which could be used to produce insect cells/baculovirus based protein sub-unit vaccines like the one from Novavax. 

At the moment, we have a licensed protein sub-unit vaccine for hepatitis B which we developed using the yeast technology platform. 

If we have access to mRNA technology, we believe we can easily adapt this technology. We have all the reactors and purification tools required for mRNA vaccine production.

If we get the antigen then the production can start immediately as we have 2 and half line sitting idle. In one line we can handle multiple dose vial and with 20 doses a vial we can deliver about 500 million doses a year. If we re-tool the other two lines for larger multiple vial capability then we would be able to deliver another 600 million doses but this would require a lead time for supply of tools from machine manufacturer and it may require a lead time of 6-8 months. But we have now one line fully ready to deliver about 500 million doses a year in multiple dose vials.

(The lines we have are suitable to fill any type of vaccine.)

At the moment we don’t have any deals with any innovators.

Please note that this interview will also be published by Health Policy Watch, under a unique syndication arrangement.

This interview was subsequently edited on March 31, to add additional details to describe manufacturing capacities of Incepta.

You can also listen to a brief interview of Abdul Muktadir here, where he describes the difficulties in engaging with originator companies on vaccines production.


II. WHAT WE FOUND INTERESTING

POLICY UPDATES:

  • A proposal for an international pandemic treaty

    WHO and the European Council, have pulled together 25 heads of states and heads of governments to support a proposal for an international pandemic treaty. In a press briefing this morning, WHO laid out the benefits of a treaty approach, including strengthening the implementation of the International Health Regulations; providing a framework for international cooperation and solidarity; addressing issues such as building resilience to pandemics and other global health emergencies; boosting national and global preparedness systems; ensuring timely and equitable access to pandemic countermeasures, including vaccines; and supporting sustainable funding and capacity for prevention, detection, and responses to outbreaks among others.

    While top WHO officials noted the IHR as a powerful tool, they also underscored the need for such a treaty for greater political commitments to address health emergencies. It was also suggested that the treaty will address issues such as “transparency in supply chains” and will have provisions on virus-sharing.

    WHO has suggested that such a treaty can be based on its Constitution and can be taken forward by the World Health Assembly.

    (As mentioned above, see our analysis from last week that brings together political and legal views on the pandemic treaty.)

    Also see this video on the pandemic treaty that pushes all the right buttons. (Pushing for a treaty on twitter, 21st century style!)

    Image Credit: Photo by Brett Jordan from Pexels

  • United States to host launch event for Gavi COVAX AMC 2021 investment opportunity: Gavi

    The United States government, a traditional donor of Gavi - The Vaccine Alliance, will host the launch of the “Investment Opportunity for the Gavi COVAX Advance Market Commitment (AMC)”. A virtual event on April 15th will see the participation of the Secretary of State and USAID Administrator on behalf of the United States.

  • COVID-19: Measures affecting trade in goods: WTO

    A useful compilation of measures taken by countries with eye-opening tariff lines one never knew existed. WTO clarifies “..The list and the information contained therein is an informal situation report and an attempt to provide transparency with respect to trade and trade-related measures taken in the context of the COVID-19 crisis. The list of measures does not pass judgment on or question the right of WTO members to take such actions and it does not alter the current long-standing practice of the WTO Trade Monitoring Exercise of verifying information and measures with members..”


NEWS:

  • Covid-19 Vaccine Deal-Making Is Fleeting Game Changer for Pharma: Bloomberg

    A telling analysis, with a string of voices from lawyers, the folks who tie up the deals. So irrespective of what high-level policy makers say on technology transfer, this is the view from the ground.

    “…Proponents of the deals laud them as exemplary of what the private sector can achieve—speeding up vaccine creation and increasing output. But some attorneys say the partnerships are an odd byproduct of a unique moment and are unlikely to spur further manufacturing deals beyond the public health emergency.

    But manufacturing partnerships on a global scale are cumbersome from a logistics perspective….Business terms, domestic and international tax implications, and intellectual property are among the issues that need to be smoothed out…”

    Bloomberg Law

  • Is the UK diverting Covid vaccines from poorer countries? Oxfam Blog

    A worrying analysis on the competition for vaccines as illustrated by the UK-India example.

    “..Vaccines are in scarce supply and, in the short-term, allocation to one country removes potential access in another. COVAX already faces a huge struggle, as do low and middle-income countries more generally, in accessing vaccines. Adar Poonawalla, CEO of Serum Institute has already indicated that COVAX will likely fall well-short of its forecast 2.3 billion doses in 2021, which depends on over 1 billion from his company. For COVAX, he has suggested, “if we’re lucky, we’ll have produced 400m by the end of the year.” Reflecting such a challenge, India will reportedly now suspend all vaccine exports for one month so as to ensure uninterrupted supply domestically. If the 5 million doses received by the UK had gone to COVAX instead, they could have increased its distribution of vaccines to LMICs (30 million so far) by over 15%…”

    Oxfam Blog

  • The Politics of Vaccine Donation and Diplomacy: Think Global Health

    “The link between the Belt and Road Initiative and donations should not come as a surprise. China has promoted global health governance, disease surveillance, and international health cooperation under the Belt and Road Initiative's "Health Silk Road" since 2015. It also sent masks, medical aid, and expertise to Belt and Road participants earlier in the pandemic. Now, China is using vaccine donations to further elevate the Belt and Road Initiative in bilateral relations…”

    Think Global Health

  • What it will take to vaccinate the world against COVID-19? Nature

    A really useful story looking closely at the production numbers of vaccines, among other aspects of vaccines’ access.

    “But the key bottleneck in mRNA-vaccine manufacture is a worldwide shortage of essential components, especially nucleotides, enzymes and lipids. This is because relatively few companies make these products, and not in sufficient numbers for global supply. Moreover, these companies are proving slow to license their manufacturing so that others could do this.

    For example, every RNA strand requires a ‘cap’ that prevents the human body from rejecting it as foreign material. It’s the most expensive component, says Kis, and the intellectual-property rights for a popular cap design are held by one company — TriLink Biotechnologies, based in San Diego, California. Similarly, a small number of companies hold the intellectual-property rights for one of the four lipid nanoparticles that form the cage around the RNA, Kis adds.

    That said, manufacturers of component parts are now expanding their production. TriLink, for example, has built new facilities in California. And Merck, based in Darmstadt, Germany, is expanding its supply of lipids to BioNTech, Pfizer’s collaborator.”

    Nature

  • Pascal Soriot: the pharma CEO navigating a vaccine storm - Financial Times

    “His reputation now rests on whether his grand ambition to bring a not-for-profit Covid-19 vaccine to the world — “the biggest CSR project in history” as one company insider describes it — becomes his defining accomplishment, or a symbol of over-reach that will permanently diminish his achievement in turning AZ into one of the pharma industry’s global powerhouses.”

    Financial Times

  • COVID-19 Vaccination and the Multilateral Development Banks: Moving Towards a More Systematic and Strategic Approach: Center for Global Development

    The writing is on the wall. Read this commentary:

    “…But how should the MDB vaccine effort intersect with global efforts like COVAX, or indeed plans to share or donate vaccine amongst countries? In this blog, we look at two issues raised by the World Bank’s approach so far and offer options for a better way forward.

    Limiting or justifying financing for bilateral vaccine purchasing outside COVAX

    While the World Bank has pledged to support COVAX, borrowing country governments can also use World Bank resources to procure vaccines via direct bilateral contracts with pharmaceutical companies or other procurement mechanisms. Initial project approvals (Lebanon, Cabo Verde, Mongolia, Tajikistan, and the Philippines) reflect this approach. It is unsurprising that countries have sought to secure vaccines outside of COVAX since—up to now—the multilateral effort restricted purchasing volumes to 20 percent of every participating country’s population.”

    Center for Global Development

FROM THE JOURNALS / REPORTS:

  • Big Pharma Takes It All: Public Eye, Switzerland

    Recommended reading.

    Public Eye lists ten strategies used by the pharma industry during this pandemic: “determine R&D priorities by potential profits alone; abuse patents to lock up knowledge, inflate prices and limit supply; direct the system towards the needs of high-income countries; avoid public accountability; design clinical trials for self-interest; socialise risks, privatise profits; embrace public investment, reject public returns; impose unjustifiable, unchallengeable prices; financialise innovation and lobby pervasively.”

  • The Absent Voices of Development Economics: Project Syndicate

    A must read. Like we noted last week, on the power that custodians of knowledge wield can exacerbate North-South divides.

    .."The lack of representation of marginalized groups in the corridors of power – political, financial, and cultural – is a growing source of global concern. Knowledge confers power, so who creates it matters. As the Nobel laureate economist Paul Samuelson famously said, “I don’t care who writes a nation’s laws…if I can write its textbooks.” "

    Project Syndicate

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III. WHAT WE ARE WATCHING:

  • Release of the report on the Wuhan field visit on the origins of the SARS CoV 2 virus: March 30

  • WHO: Member States Informal Consultation on a draft options paper for the WHO Global Coordination Mechanism on the prevention and control of Noncommunicable Diseases - April 1

  • WHO Member State virtual information session on WHO Foundation: April 6

  • Webinar Watch: Medicines for the People: what will the next decade look like? organized by DNDi, on March 30.


IV. TWEET OF THE WEEK

For the record:

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