Policy & Regulation
IAVI and Wellcome Issue a Global Call to Action: Monoclonal Antibodies for COVID-19 and Other Diseases Could Save Millions of Lives
11 August 2020 - - US-based nonprofit scientific research organization IAVI and UK-based health foundation Wellcome are urging the global health community, from pharmaceutical companies to academic institutions to governments, to join efforts to make monoclonal antibodies globally accessible, the organisation said.

The organizations issued this call with the publication of "Expanding Access to Monoclonal Antibody-Based Products: A Global Call to Action."

This publication demonstrates that despite the transformative impact that mAbs have had in the treatment of a range of life-threatening diseases, they are currently not available to people living in low- and middle-income countries (LMICs).

The call to action couldn't come at a more critical time: the novel coronavirus pandemic has triggered unprecedented collaborative efforts to accelerate research and development of mAbs for COVID-19 treatment and prevention.

mAbs have the potential to play an important complementary role to COVID-19 vaccines, especially for those individuals who, due to age or medical conditions, may not benefit from a vaccine.

Should mAbs prove to be effective tools in the COVID-19 response, it will be essential to develop new approaches to ensure their timely global availability at scale in order to help end this pandemic.

The call to action provides clear guidance for the global health community by identifying opportunities to enable and accelerate equitable global access to COVID-19 mAbs.

If successful, the new approaches and partnerships that arise for COVID-19 can also set precedents to support increased global access to mAbs targeting many other diseases.

Monoclonal antibodies are one of the most powerful tools in modern medicine. These proteins, derived from human immune cells, act specifically against targets ranging from cancerous cells to viruses and bacteria, or alter precise immune pathways to augment an individual's ability to fight cancer or block aberrant immune responses in autoimmune diseases.

Millions of people have benefited from mAb-based therapies to treat non-communicable diseases in the 30 years since the first one was licensed.

For a sizeable and growing number of diseases, mAb therapies are not only significantly more effective than previously available therapies, they are often better tolerated as well.

mAb products have dramatically improved survival rates for people with breast cancer, melanoma, lung cancer, and other difficult-to-treat cancers. They have provided new, more effective approaches for treating a range of autoimmune diseases.

In addition, mAbs have been developed for several infectious diseases, and active research efforts are underway to evaluate their potential to prevent and treat a number of globally relevant infectious diseases including Ebola, HIV, and, as mentioned, COVID-19.

But mAbs, which are among the most expensive pharmaceutical products in the world to develop and produce, are inaccessible for most of the world's population.

And the few mAbs that are licensed in LMICs are often unavailable, due to affordability concerns or lack of enabling policies and structures in public health systems.

This major access gap must be addressed because mAbs represent a growing proportion of the product pipelines of pharmaceutical companies.

Further, as many of the diseases targeted by mAbs disproportionately affect people living in LMICs, developing effective new solutions for increased global access to mAbs is imperative.

Analyzing case studies, and including insights from more than 100 interviews with stakeholders including product developers, global health organizations, manufacturers, regulators, funders, policy makers, healthcare providers, and ministries of health, the call to action identifies opportunities for the global health community to create solutions to make mAbs widely accessible.

"Expanding Access to Monoclonal Antibody-Based Products: A Global Call to Action" proposes four parallel actions to ensure widespread access to mAbs in LMICs: Increase advocacy and awareness of the life-saving potential of mAbs and the need to make them more widely accessible; Develop expanded policy and regulatory pathways to increase availability of mAbs; Invest in and apply new technologies to lower development costs; and Establish alternative business models to enable innovative market approaches in low-, middle-, and high-income countries that promote global access.

Action is urgently needed. Pharmaceutical companies and product developers, global health agencies, academic institutions, philanthropic organizations, civil societies, governments, and ministries of health must join forces to make global access to transformative monoclonal antibody products a priority and a reality.

IAVI and Wellcome say they will convene a series of meetings with key influencers and stakeholders in 2020 and 2021 to catalyze progress on the call to action for mAb access.
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