Vaccine Makers Ramp Up Production, Donations to Protect IP

In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally.

In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally. Efforts to promote “vaccine equity” and “dose sharing” also aim to limit challenges to international patent protections, as manufacturers maintain that calls to waive intellectual property (IP) rights for pandemic vaccines will stymie innovation and the development of new preventives against COVID variants and future disease outbreaks.

The issue has heated up as the Biden administration announced support for a waiver to IP protection for COVID-19 vaccines under the World Trade Organization (WTO), a move that surprised manufacturers as well as other industrial nations. European leaders at the recent G20 meeting in Rome instead backed voluntary and compulsory IP licensing agreements, technology transfers, and patent pooling arrangements to help low- and middle-income countries access and produce vaccines. The European Commission (EC) said it would seek to open global supply chains, expand vaccine production capacity, and end export bans on vital supplies, explained EC president Ursula von der Leyen, as part of a program to promote voluntary licensing and knowledge transfer in the context of the TRIPS trade agreement. Along with setting these goals, manufacturers pledged to provide more than 1 billion vaccine doses from BioNTech/Pfizer, Johnson & Johnson, and Moderna at no- and low-profit rates to lower income countries.

Similarly, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) announced programs to advance global vaccine equity based on projections that manufacturers will produce some 11 billion doses this year. The program supports greater dose sharing with other countries, more collaboration to increase vaccine output, eliminating trade barriers that block access to needed materials, and partnering with governments to assist low-income countries distribute available vaccine doses.

Expanding vaccine production

In addition to promoting expanded access to vaccines made in the US and Europe, policy makers look to advance biopharma production on a global basis. IFPMA eyes collaborations to increase access to needed supplies of raw materials and to maximize COVID-19 vaccine output without compromising safety and quality.

An initial step is to link vaccine output to available fill and finish operations, an initiative advanced by the COVAX Supply Chain and Manufacturing Task Force, recently formed by leading international health organizations to address current gaps in manufacturing inputs and to ultimately expand production of vaccines and therapies to combat future disease outbreaks. The task force includes IFPMA, the Biotechnology Innovation Organization (BIO), the Coalition for Epidemic Preparedness Innovations (CEPI), the World Health Organization (WHO), the GAVI vaccine alliance, the Bill & Melinda Gates Foundation, and other public health entities. Immediate goals involve coordinating supply chains to identify shortages in raw materials needed for vaccine production and facilitating voluntary technology transfers between manufacturing partners.

Looking to the future, the task force will work to expand vaccine manufacturing capacity in multiple regions by upgrading existing facilities, stimulating public-private investments in vaccine manufacturing innovations, and developing sustainable regional supply chains. The US recently provided $2 billion to support COVAX and additional funding in the near future. At the same time, the Biden administration’s promise of some 80 million vaccine doses for developing nations appeared highly inadequate.

By the time the WTO addresses biopharma IP issues more formally at its year-end ministerial meeting, manufacturers expect that expanded production and distribution of COVID-19 vaccines will be filling global vaccine needs more visibly. Industry has gained strong support for patent protections from Republicans on Capitol Hill, and the notable success of firms in developing and producing effective COVID vaccines in less than a year has heightened support for IP protections and their potential for further stimulating biopharma innovation. And the fact that the Chinese government expressed enthusiasm for patent waivers only heightens concerns about the impact of such a critical change.