On February 24, 2021, IAVI co-organized a webinar with the Department of Biotechnology (Ministry of Science and Technology, Government of India), and Wellcome to understand the challenges and opportunities for research and development of innovative biotherapeutic treatments for COVID-19, such as monoclonal antibodies (mAbs), and raise awareness about the necessity of ensuring access to these products for patients across the world. The webinar was organized as three panel discussions with an impressive and diverse group of panelists from global and regional health organizations, regulatory organizations, academic institutions, and private industry, including product developers and manufacturers.

Bridging off the IAVI and Wellcome call to action, introductions made by Dr. Mark Feinberg, IAVI president and CEO, and Dr. Ayesha Sitlani, associate vice president of antibody strategy at IAVI, noted the necessity of easing barriers to global access of antibody products in light of the emerging variants of SARS-CoV-2, the virus that causes COVID-19, across the globe, and the key role of these products in treatment and possibly prevention. In a similar vein, Dr. K VijayRaghavan, principal scientific advisor to the Government of India; Dr. Renu Swarup, secretary of the Department of Biotechnology; and Dr. Vinod Paul, member of the Government of India run policy think tank, NITI Aayog, spotlighted the need to supplement vaccines with therapeutics and create an enabling ecosystem by which these products can be produced, manufactured, and distributed in an equitable fashion. They further noted India’s potential manufacturing and regulatory capabilities in hastening this process and replicating the vaccine success in antibodies.

The first session of the webinar, chaired by Dr. Rafi Ahmed, professor at the Emory Vaccine Center, focused on understanding whether antibodies are a viable strategy for COVID-19 treatment. There was a general consensus among panelists that mAbs are an integral tool in combating SARS-CoV-2, especially for individuals at higher risk of progressing to severe disease such as the immunocompromised, including cancer patients, the elderly, and those with co-morbidities, as well as those who do not have access to a vaccine, or are opting out of receiving one. However, the panelists also noted that while mAbs against SARS-CoV-2 have been shown to be effective in the early stages of COVID-19 infections, they generally do not help patients who are severely ill with COVID-19. In order to optimize treatment for severely ill patients, then, they noted that optimized mAbs, with altered effector functions, may be effective in combination with other treatments. Dr. Vivekanand Jha, executive director of the George Institute of Global Health, and Dr. Randeep Guleria, director of the All India Institute of Medical Sciences, also pointed out the immense importance of understanding the diverse contexts and needs of health systems in which antibodies are being administered, especially public health systems where early diagnosis, delivery, and administration are often challenges.

The second session, moderated by Dr. Lindsay Keir of Wellcome, began by highlighting the importance of the clinical positioning of antibodies; in particular, the development of antibodies with different product profiles and modes of action for different stages of COVID-19. For development success alongside clinical positioning in low- and middle-income countries (LMICs), the panel also noted the necessity of initiating key national and global partnerships early in the process, as was seen over the past year with the development of various COVID-19 vaccines. This means optimizing pooled procurement options, harmonizing regulatory processes, and scaling up distribution and administration methods. Dr. Lars Peterson, COO of FUJIFILM Diosynth, highlighted that manufacturing challenges and capacity limitations are a key bottleneck, even though “manufacturing costs are a fraction of the total cost in the antibody development pipeline. We, therefore, need to be more standardized across platforms in this pipeline to increase efficiency, decrease cost, and ensure access.”

The final session, chaired by the World Health Organization’s Dr. Vasee Moorthy, explored the mechanisms and investments required to enable broad access to monoclonal antibodies for COVID-19 in LMICs, at both national and global scales. Dr. VM Katoch, secretary at the Department of Health Research, pointed to the existing capabilities within Indian systems for the introduction and uptake of therapeutics. Summarizing key points in previous discussions — including the necessity of ecosystem strengthening, ensuring open licensing for large-scale manufacturing, and global collaborations and public-private partnerships for efficient supply, delivery, and access to both preventive measures and therapeutics — the panel additionally spotlighted issues of equity and equitability. Dr. Mandeep Dhaliwal from the United Nations Development Programme noted that “only 20% of procurement and pricing information with regards to COVID-19 vaccines has been disclosed.” Transparency within the supply chain is, therefore, critical. One of the solutions brought forth by panelists was the creation of a knowledge hub for supply chain components. The role of regional institutions was also highlighted as integral to ensure that there is accountability in decision making at all levels by Africa CDC’s Dr. John Nkengasong.

Dr. Sundeep Sarin, from the Department of Biotechnology, closed the webinar with these words: "We need to develop and sustain an innovative, positively disruptive model which can be used to ensure access to monoclonal antibodies now, and in the future.”

You can access the full recording of the webinar here.

A recording of the previous webinar in this series, co-convened by IAVI, Wellcome, and Unitaid, on how COVID-19 may pave the way for global access to monoclonal antibodies can be found via Wellcome. To read a summary of the convening, follow this link.

 

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