COVID Vaccine Makers Reject Offers to Expand Production Despite Citing Scale-Up as IP Waiver Alternative

Although prominent COVID-19 vaccine makers have argued for ramping up production to help meet global vaccine needs as an alternative to waiving intellectual property (IP) rights, several pharma companies, including the world’s biggest generics maker, have been unable to secure such manufacturing arrangements.

Drug industry groups came out strongly against the Biden administration’s about face when the president unexpectedly voiced support for temporary waivers of COVID-19 vaccine IP rights during the pandemic (DID, May 13). The industry contends that ramping up production would be the best way to achieve the goal of improving global vaccine access, arguing that waiving IP rights would not produce meaningful results and could lead to severe raw material shortages. But vaccine makers have also declined to partner with a number of companies that claim doing so would help solve the problem of vaccine inequity.

Biolyse Pharma, one of Canada’s largest generic manufacturers, has expressed eagerness to pitch in on manufacturing to help countries around the world gain access to vaccine supplies. But although it was identified as a candidate for production and/or fill finishing and is equipped to manufacture adenovirus vaccines at its 120,000 square foot facility in Ontario, it has been turned down thus far by Johnson & Johnson (J&J) and AstraZeneca (AZ).

In the case of J&J, Biolyse was told in February that J&J was satisfied with the contract manufacturing network it had organized. the company’s founder and production manager, Claude Mercure, told FDAnews. For AZ, Biolyse still hasn’t heard back despite reaching out at least three months ago, he said.

Biolyse is capable of making a significant contribution of doses, after scale-up, to the tune of 50 million doses per year, Mercure claimed, but has thus far not been able to hash out an agreement. The company began preparing to manufacture biosimilar products approximately four years ago. That initiative was put on hold, but not before the equipment and laboratory were mostly set up, Mercure said.

“It occurred to us a year ago that the equipment we had was the same equipment that could be used to fabricate adenovirus vaccine,” he said. “It’s very simple. They don’t want us producing vaccines. The imperative of big pharma to keep their monopoly is definitely a part of their thinking and I think that’s what we’re looking at now.”

With its lack of success in reaching an agreement with a vaccine maker, the company is also in contact with the Canadian government and has been seeking a compulsory license since mid-March, according to John Fulton, a spokesperson for Biolyse. He said that he has personally spoken to more than 30 government officials in an attempt to get clarification on how to start the licensing process. A compulsory license — which Fulton believes the company will receive — requires a recipient country signed up, and Bolivia has stepped up to the plate. The initial doses from the company’s facility will go to Bolivia should a license be granted.

Even the world’s largest generics maker, Teva, has not been able to reach an agreement with big vaccine makers, according to reports. Bangladesh’s Incepta and Denmark’s Bavarian Nordic, likewise, have reportedly been unable to get a deal.

The World Trade Organization (WTO) will meet to discuss waiving its agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on June 8-9. Any proposal would need to garner unanimous consent from the organization’s 164 member countries to go into effect, and if that occurs, it would then need to be integrated legislatively by individual countries. Despite the U.S.’ backing for temporarily waiving IP rights, there is still strong opposition from the EU, UK, and others, and the WTO process is expected to take months at the least. — James Miessler