Will the Biden administration’s support for patent waivers actually provide more COVID-19 vaccine to the developing world? Unfortunately the answer is no.

Yesterday, the Biden administration announced that it would support the waiver of intellectual property protection for COVID-19 vaccines in order to facilitate, “the provision of vaccines for the developing world.” In a statement from U.S. Trade Representative Katherine Tai, the Administration stated its belief that, “in service of ending this pandemic, we support the waiver of those protections for COVID-19 vaccines.” 

Global advocacy groups have argued for waivers on World Trade Organization rules that protect the intellectual property (IP) on OCVID-19 vaccines, which would allow any company to produce a proven COVID-19 vaccine without a license or royalty. This initiative was pressed by India and South Africa, who are currently suffering massive outbreaks of COVID-19. President Biden as a candidate promised to support such waivers.

President Biden

This decision was announced by Tai after meetings to get input from trade partners, health experts and advocates, labor groups, and the major vaccine manufacturers. But regardless of what was presented, the president ultimately decided to support the waiver.

Vivek Murthy

Another administrative representative, U.S. Surgeon General Vivek Murthy, said on Wednesday that the Biden administration’s support of a Covid-19 vaccine waiver proposal, “put people over patents.” “To me it was a value statement,” Murthy told CNN’s Erin Burnett on “OutFront.”

The real question is whether this moral imperative from the administration will actually get more vaccine to the developing world. It does not seem likely.

First, it is not clear that patent rules will be eased. Members of the WTO must unanimously agree to loosen the restrictions, and other countries — including the European Union and Switzerland — have resisted the step.

Second, the real obstruction to getting vaccines to the developing world is manufacturing. India and Brazil subcontractors have had access to the AstraZeneca vaccine for months, but have failed to be able to manufacture the vaccine. 

The leader of one of the Indian manufacturers of the AstraZeneca vaccine, Adar Poonawala, has actually left the country because of reported threats against him after failed attempts to produce the AZ COVID-19 vaccine. Despite this failure, his company, Serum Institute of India, is a legitimate manufacturer that has made a good faith effort to make the vaccine. This highlights the difficulty in making something as complex as these vaccines.

Adar Poonawalla

In that regard, it is important to remember that several contractors in the U.S. and the E.U. have also failed to produce the AstraZeneca vaccineThe mess at the Emergent plant in Baltimore is an example of this problem. Too make these vaccines you really need access to manufacturing expertise, not necessarily the intellectual property.

While the administration has focused on easing patent restrictions on vaccines, some of President Biden’s advisers have pointed to the global supply chain for vaccines rather than intellectual property as the stumbling block. This includes not just manufacturing, but accessing the specialized materials and technology needed to make the vaccines.

Without the manufacturing expertise of the companies that developed these vaccines, it is unlikely that anyone else will readily produce COVID-19 vaccines. And now, without the ability to grant licenses or gain royalties, no company has any incentive to “do the right thing.”

One has to wonder whether in the future any company will risk millions of dollars in development costs knowing they may not control the resulting products.

Published by jbakerjrblog

Immunologist, former Army MD, former head of allergy and clinical immunology at University of Michigan, vaccine developer and opinionated guy.

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