Manufacturing hurdles slowing Covid jabs rollout: industry

Geneva, Switzerland: Removing intellectual property rights from Covid-19 vaccines or forcing companies to share technology would not speed up or even slow down production, according to the industry.

Proponents of removing intellectual property rights argue that more businesses in more countries will manufacture the vaccines, allowing for greater access in poorer nations that have previously received few doses.

South African President Cyril Ramaphosa, whose country is co-leading an effort at the World Trade Organization to exclude Covid-19 vaccines from intellectual property rights, insisted Friday that the vaccines were "a public benefit and must be recognized as such."

"We call on the pharmaceutical industry to directly transfer this technology free of intellectual property barriers to low and middle-income countries," he told an event hosted by the World Health Organization.

"Let us together challenge vaccine nationalism and show that protecting intellectual property rights does not come at the expense of human lives."

Vaccine manufacturers have shown a general willingness to collaborate in order to increase demand, but at a separate event on Friday, industry leaders argued that IP exemptions and forced technology sharing were the wrong way to go.

10 billion doses 

According to Thomas Cueni, president of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), an IP waiver "wouldn't give us the tools to create more doses of vaccines."

He noted that approximately 275 manufacturing deals, including technology transfer among fierce competitors, had assisted the industry is moving from zero to one billion Covid-19 vaccine doses already made, with a target of 10 billion doses by the end of the year.

However, industry participants stated that this goal was contingent not on IP controls or wider technology transfers, but on addressing serious issues related to trade barriers and export restrictions that impeded the movement of vaccine components and vaccines themselves.

"Vaccine manufacturing is not all about patents," said Sai Prasad, president of the Developing Countries Vaccine Manufacturers' Network and head of quality operations at Indian vaccine maker Bharat Biotech (DCVMN).

'Complex' 

Prasad emphasized the difficulty in ensuring that manufacturers have the necessary equipment and know-how to meet the rigorous quality and safety requirements needed for vaccine production.

"This is a very complex space, very complicated science, manufacturing is very complicated.... We need to be careful who we are transferring technology to."

With vaccine skepticism already high, manufacturing issues may have disastrous effects, according to Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization (BIO).

"We don't want to do something that undermines vaccine confidence," she said.

"We don't want to do anything to undermine vaccine confidence," she said.

"We need to recognize that there are only a handful of manufacturers across the globe who have that expertise at hand, and we need to focus on getting them the materials they need to produce as many doses as quickly as possible."

A global shortage of more than 100 components and ingredients needed for vaccine manufacturing, according to industry participants, is a major challenge.

While much effort has been put into ensuring an adequate supply of glass vials and syringes, there are currently shortages of the lipids used to manufacture the mRNA Covid-19 vaccines manufactured by Moderna and Pfizer-BioNTech, as well as tubing and plastic bags used in the vaccine production process.

In the face of such shortages, Moderna CEO Stephane Bancel told reporters that attempting to move technology to manufacturers less prepared to produce large quantities of vaccine could backfire.

"If we have more players coming into space, (they will be) taking more of the raw materials away from people (positioned) to make vaccines for this year," he said.

McMurry-Heath agreed

"Trying to diffuse the limited raw materials that we have right now across many more manufacturers that perhaps don't have experience manufacturing vaccines, could jeopardize the progress we are on track to make," she warned.

Moderna plans to deliver one billion doses of its Covid-19 vaccine by the end of this year, and another 1.4 billion doses the next year.

However, Bancel cautioned that broadening its efforts to share technology to assist others in manufacturing its jabs might potentially delay production.

Since moving technologies and expertise takes months, he claims that new partners introduced this year would have "nearly no effect" on global vaccine production this year.

However, "it will slow down our ability to scale up in 2021", Bancel said, pointing out that it would require moving staff involved in production over to the technology transfer process.

"If we distract the small team of engineers we have to do those tech transfers now," he warned, "the impact on lives and the spread of the virus in 2021 will be very large."
 

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