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This small Canadian drugmaker wants to make J&J vaccines for poor nations. It needs more than a patent waiver.

Sarah Jane Tribble and Arthur Allen, Kaiser Health News on

Published in News & Features

Through COVAX, Castillo said, Pfizer will deliver up to 40 million doses in 2021 to countries across the globe such as Bosnia, Tunisia, Rwanda, Peru, the West Bank and the Gaza Strip, and Ukraine.

Nicole Lurie, a senior adviser at the Coalition for Epidemic Preparedness Innovations, said the waiver does not address the short-term need for supplies or the potential for countries to donate excess doses.

Manufacturers have already announced that they hope to supply up to 14 billion doses of vaccines globally in 2021 ― that’s triple the previous annual vaccine output, according to a discussion paper posted by IFPMA and organized for an international summit on shortages.

The report warned that a shortage of supplies may result in several current COVID-19 manufacturers not being able to meet current vaccine manufacturing commitments. There’s concern about the need for single-use bioreactor bags used for cell culture and fermentation for all vaccines. And, the lipid nanoparticles used to create mRNA vaccines are also in tight supply, with only a few capable suppliers currently operating at scale.

So far, more than 1.21 billion vaccines doses have been administered worldwide, but mostly in the U.S. and other wealthy countries. Canada’s Biolyse said that if it can manufacture the J&J vaccine, a small developing country has committed to buying it.

Without a voluntary consent from the manufacturer, though, Biolyse is now working to obtain a compulsory license to produce the J&J vaccine, which would force J&J to waive its intellectual property rights. Such a legal maneuver is allowed under current international law, but the Canadian government would have to support Biolyse’s license application. So far, it has not.

Canadian officials have met with Biolyse and other companies, as well as international vaccine developers, about the feasibility of making their products in Canada, said Sophy Lambert-Racine, a spokesperson for Innovation, Science and Economic Development Canada.

The “existing Canadian biomanufacturing assets were deemed to be of an insufficient scale or utilized technology platforms which were not suitable to the needs of these firms,” said Lambert-Racine, adding that the Canadian government is now investing more than $1 billion into COVID-19 vaccine and therapeutics research and development.

 

Biolyse is a small company with about 50 employees, including “scientists who have spent their working lives producing vaccines,” Fulton said. The company has said it still needs about $4 million in financing to finish setting up manufacturing lines.

Claude Mercure, a co-founder of Biolyse, said that even if the company doesn’t share the patent and the technology, he is confident his company can figure out how to make the J&J vaccine, which uses a disabled adenovirus to deliver instructions to the body on fighting the coronavirus. In recent weeks, though, other independent scientists have reached out to collaborate and potentially develop a new vaccine.

Trying to remake the J&J vaccine without a technology transfer and partnership would potentially take years, but with a strategic partnership Biolyse could be making vaccines within four to six months, Biolyse executives said.

Regardless of what happens with the waiver, the tenor of international conversation about intellectual property rights puts pharmaceutical companies on notice, said Mara Pillinger, a senior associate in global health policy and governance at Georgetown’s O’Neill Institute for National and Global Health Law.

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(KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.)

(c)2021 Kaiser Health News Distributed by Tribune Content Agency, LLC