Vaccine industry leaders say manufacturing hurdles slowing rollout

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Removing intellectual property protections from Covid-19 vaccines or pressuring companies into technology sharing will not speed up production of the jabs, and could even slow it down, the industry has warned.

Proponents of doing away with IP rights say more companies in more countries could produce the vaccines, providing broader access in poorer nations that so far have seen few doses.

South African President Cyril Ramaphosa, whose country is co-leading a push at the World Trade Organization to exempt Covid-19 vaccines from IP rights, insisted Friday the jabs were “a public good and must be recognised 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 makers have voiced broad commitment to cooperating to boost production, but at a separate event on Friday, industry representatives insisted that IP waivers and forced technology sharing was the wrong way to go.

10 billion doses

An IP waiver “wouldn’t give us the tools to produce more doses of vaccines”, Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), told reporters.

He pointed out that around 275 manufacturing deals, including on technology transfer among staunch competitors, had helped the industry go from zero to one billion Covid-19 vaccine doses already produced, with the goal of 10 billion doses by the end of the year.

Industry players said though that that target hinged not on IP restrictions or broader technology transfers, but on resolving serious challenges, linked to trade barriers and export restrictions, hindering the movement of vaccine components and the vaccines themselves.

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

‘Complex’

Prasad pointed to the complexity of ensuring that manufacturers have the equipment and know-how to meet the stringent quality and safety standards required in 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 scepticism already rampant, manufacturing difficulties could have dire consequences, warned Michelle McMurry-Heath, who heads the Biotechnology Innovation Organization (BIO).

“We don’t want to do anything to undermine vaccine confidence,” she said.

“We need to recognise 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.”

Industry players said a major challenge was a global shortage of more than 100 components and ingredients needed for vaccine manufacturing.

While much effort has gone into ensuring there are enough glass vials and syringes, today there are shortages in the lipids used to produce the mRNA Covid-19 vaccines made by Moderna and Pfizer-BioNTech, as well as tubing and plastic bags used in the vaccine production process.

Faced with such shortages, Moderna chief Stephane Bancel told reporters that pushing for technology transfer to manufacturers less equipped to produce large quantities of vaccine could backfire.

Could ‘slow down’ production

“If we have more players coming into the 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 jeopardise the progress we are on track to make,” she warned.

Moderna is aiming to produce one billion doses of its Covid-19 vaccine by the end of this year, and hopes to produce another 1.4 billion doses next year.

But Bancel warned broadening its efforts to share technology to help others manufacture its jabs could actually delay production.

Since transferring the technology and expertise takes months, he said new partners added now would “have almost no impact” 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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