TOPICS: COVID-19

 

The COVID-19 pandemic has had a devastating impact on global public health, resulting not only in economic regression with national security implications, but most importantly it has caused devastation to lives and livelihoods, with a disproportionate impact on low-income countries (LICs) and lower middle-income countries (LMICs).

Developing Country Vaccine Manufacturers Network (DCVMN) members can have a major role to play in this and in achieving a faster roll-out of new vaccines at scale.

It is, therefore, important that healthcare solutions are developed and catered to LICs and LMICs. It is also imperative that the international community provides global access to health care solutions so as to create the greatest impact.

However, there are challenges to overcome, such as knowledge, technology, knowhow, expertise, long term ROI financing, high-risk funding, regulatory and trade barriers, and more. Individually, each of these hurdles are complex, but collectively they are interconnected and highly challenging to overcome

Unlike medical drugs, which involve small molecules that are chemistry-based, the complexities of vaccine product development and manufacturing are biological in nature and so pose a range of different and often more complex challenges. Trained manpower is a fundamental requirement in LICs and LMICs for innovation and manufacturing. There are three distinctly different processes involved in the manufacturing of vaccines: drug substance involving upstream & downstream processes, followed by formulation, then finally fill and finish of the vaccine product. Each of these requires a different type of knowledge and skill set.

At the drug substance level itself, there are several complexities involved, such as platform technologies, yields or capacity to name a few. This requires a thorough understanding of the subject in addition to Good Manufacturing Practice training before getting into the tech transfer. Quality control alone represents up to 70% of the full manufacturing process. Matching the scale-up capacity of both the Drug Substance and Drug Product facility becomes imperative, with respect to vaccine capacity.

The other key challenge requiring global attention is to stop the transmission and spread of new variants, which have already started creating disruption. Therefore, detection, isolation and gene sequencing of these variants, followed by the development of effective vaccines against these new variants, addressing regulatory processes to fast track deployment, are key initiatives. Developing Country Vaccine Manufacturers Network (DCVMN) members have a major role to play in this and in achieving a faster roll-out of new vaccines at scale.

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To take cognizance of all challenges involved and bring global stakeholders to one platform, the “Global C19 Supply Chain and Manufacturing Summit” was convened over two half-days by Chatham House on 8-9 March, co-sponsored by COVAX, vaccine makers and founding partners of the Access to COVID-19 Tools Accelerator (ACT-A), including International Federation of Pharmaceutical Manufacturers & Association (IFPMA), BIO and DCVMN. Bringing together over 150 participants from around the world including but not limited to high level representatives of governments, regulators, international agencies, COVAX partners and CEOs of both industrialized and developing countries, attendees discussed the challenges and solutions to further increase not only global vaccine manufacturing capacity but also mitigate input supply challenges (raw materials, consumables, equipment) with specific reference but not limited to single use components like bioreactor bags, filters, tubing, lipid nanoparticles(LNPs), vials and much more.

Equitable access to vaccines against COVID-19 pandemic is the most cherished goal at the heart of DCVMN along with its COVAX partners. Right from the time the gene sequencing was made available, our members have been diligently engaged in deploying various platform technologies for research, development manufacturing, scaling up and scaling out of the much needed COVID-19 vaccines. In this endeavor, it was so heartening to witness that while on one hand DCVMN members were instrumental in scaling up production from zero to millions of doses in a record time span of 10-12 months, at the same time they also licensed in, from large pharma the likes of Astra Zeneca and J&J, and licensed out technology to fellow members within the DCVMN, so as to ensure availability of affordable vaccines to millions of people in LICs and LMICs.

One of the remarkable achievements of the Serum Institute of India (SII), a DCVMN member, was becoming the first to support COVAX by ensuring supplies to Africa within a week of obtaining World Health Organization Emergency Use Listing. As of 11 March, DCVMN members had already produced and supplied around 200 million doses3 globally, accounting for almost 50% of the total volumes of COVID-19 vaccines produced worldwide to cater to needs of various countries. This includes the delivery of 27.7 million doses4 through COVAX to 13 countries.

We now seem to be at the end of the beginning of this pandemic. The roadmap is partially clear and we now have vaccines available in some countries to some populations, but this has to be expanded to all countries and all populations in need, especially in LICs and LMICs. 

The key question is how do we achieve this? 

The answer probably lies in fostering partnerships, encouraging technology transfers, boosting funding and investments to enable large-scale manufacturing, and global access by incentivising and facilitating such partnerships between innovators and manufacturers. Also by finding ways to further ramp up capacity in existing facilities and putting up additional manufacturing facilities in LICs and lower MICs for immediate protection of all populations in all countries, as well as sustainable scaling up of capacity for long term preparedness for the next pandemic.

We would like to emphasize that at DCVMN we support global products, local manufacturing, and to leave no one behind!


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