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Big vaccine makers turn down offers to make more shocks – POLITICO

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With much of the world starving for coronavirus vaccines, a group of companies is offering to work with larger drug manufacturers to boost production. But they get the same answer: no thanks.

Biolyse in Canada, Incepta in Bangladesh, Teva in Israel and Bavarian Nordic in Denmark have all asked for assistance in making vaccines. So far, nobody has a deal.

This reluctance to join forces is even more puzzling given Big Pharma’s line that current manufacturing capacity is responsible for the vaccine shortfall. It is this line of reasoning that drug manufacturers use to counter arguments for abandoning intellectual property for vaccines – a movement that got a jolt last week when the US rhetorically backed the idea.

“[Europe’s] The focus should remain on building partnerships and investing in facilities to increase capacity to meet the needs of citizens across Europe [and] all over the world, ”said Nathalie Moll, General Director of the European Federation of the Pharmaceutical Industry and Associations, following the announcement in the US.

Many European decision-makers have also endorsed this line. “The limiting factors in the manufacture of vaccines are production capacity and high quality standards, not patents,” said a spokeswoman for Chancellor Angela Merkel.

However, recent history shows numerous examples of the industry turning down offers of help from other drug manufacturers – citing the complexity of the process, safety concerns and the lack of time to complete the technology transfer.

The specials

These willing partners are companies that together have a global presence and, in principle, the ability to produce millions of cans.

Teva, for example, is the world’s largest manufacturer of generic medicines. CEO Kåre Schultz said earlier this year that he wanted to help manufacture some of the vaccines that are approved or about to be approved.

Canadian drug maker Biolyse, which makes sterile injectable drugs, is smaller but says it has the potential to produce 50 million doses of a vaccine a year once it’s approved. According to one of his advisors, John Fulton, if the company had gotten the green light a year ago, it would have taken the company six months to manufacture vaccines – and would now be in the middle of a year. It has contacted several different companies that make vaccines, including Johnson & Johnson and AstraZeneca.

Incepta from Bangladesh is now producing several non-coronavirus vaccines for export. Incepta chairman and chief executive officer Abdul Muktadir said that Incepta can produce mass antigens for coronavirus vaccines using almost all of its technology platforms. In an interview with Geneva Health Files in March, Muktadir said the protein subunit used in the Novavax jab and mRNA products, which include the jabs made by BioNTech / Pfizer and Moderna, are the easiest vaccine technologies to produce are.

If the antigen has already been provided, he said “production can start immediately” as Incepta has several idle lines. Muktadir estimates that using just one of these lines, Incepta could fill vials for around 500 million doses a year.

The Bangladeshi government urged AstraZeneca to allow Bangleshi companies to manufacture the Oxford / AstraZeneca vaccine, according to local media. This request is pending as it is unclear whether the Laboratory of Directorate-General Medicines Management meets global standards for vaccine exports.

In Denmark, the biotech company and vaccine manufacturer Bavarian Nordic is also hoping for a deal. In an email, a spokesman said it was in contact with most of the developers of approved coronavirus vaccines, as well as those with near-market vaccines. “We are discussing how we can best help with the manufacture and / or filling of vaccines,” said the spokesman.

No thank you

In many of these cases, the vaccine developers contacted stated that they already had sufficient partnerships to manufacture vaccines.

According to Fulton, Johnson & Johnson told Biolyse it had “sufficient manufacturing capacity at the companies they worked with”. None of the other vaccine developers Biolyse contacted, including AstraZeneca, were interested in his help, Fulton said.

For their part, Teva and Incepta attributed the rejection of their offers of assistance to vaccine manufacturers’ preference to work with either contract manufacturers or other large pharmaceutical companies.

“We really wanted to help if we could,” Tevas Schultz told Bloomberg. “The companies we were in contact with have opted for traditional contract manufacturers, or they have opted for partnerships with large pharmaceutical companies.”

Inceptas Muktadir sees it similarly: “Innovator companies work without any problems in their comfort zone and do not want to deal with unknown companies.”

safety first

Vaccine developers, for their part, declared their opposition by citing the highly complex process of making vaccines and the need for safety – implying that some potential partners may not be able to make the shocks.

“This is a complex biological process that relies on complex supply chains for raw materials and the distribution of the finished product, as well as yield from batches,” said an AstraZeneca spokesman. “And above all, patient safety must always come first.” AstraZeneca currently has over 20 delivery partners.

Johnson & Johnson also pointed out the complexity of the process. There are “a limited number of manufacturers with locations capable of producing the required volume of high quality, safe vaccines needed to fight this pandemic,” said a spokesman, adding that Johnson & Johnson is almost I have rated 100 different locations and now “several manufacturers” have collaborations. ”

With the BioNTech / Pfizer vaccine, most of the doses come directly from their own facilities. The German-American duo also has partnerships with over 15 contract manufacturers who help with production, said a spokesman.

According to Pascal Soriot, CEO of AstraZeneca, there’s another reason vaccine developers can’t get new partners – they’re too busy.

With vaccine developers working 24/7 to develop and manufacture vaccines, Soriot acknowledges that their engineers simply don’t have the time to train more people on the production line.

“Even if we give access to the technology and tell people, ‘Here’s the recipe,’ there is no way we can train these people to make the vaccine because our engineers are working tirelessly with our existing partners,” he said in early May according to Business Insider.

There is another motive behind these rejected offers, said James Love, director of Knowledge Ecology International, who advised Biolyse: “Vaccine manufacturers want to control the pricing and distribution of their products, and most do not want to freely share their knowledge. like, ”he said.

The problem is that the global urgency for ramping up production is real and growing. In an interview with POLITICO earlier this week, World Trade Organization Director General Ngozi Okonjo-Iweala pointed out that Pakistan, Bangladesh, Indonesia, South Africa and Senegal have facilities that could potentially be converted to produce coronavirus vaccines.

Manufacturers must “a[n] honest look “to see if they can be compared to any other company that could make their butts,” she said.

Pharmaceutical companies “need to act quickly rather than resist,” she added. “You have to go in and put your hands up and say … ‘We are ready to work with you in Bangladesh, we are ready to work in Pakistan.'”

Walk alone

For Biolyse, these rejections are not the end of the road. If it doesn’t work with a vaccine developer, it can go through a compulsory license alone. This is a path previously taken by Biolyse during the H5N1 outbreak with Roche’s influenza drug Tamiflu in 2006. By a stroke of luck – and extensive legwork – Biolyse obtained the generic Tamiflu, which was added to Appendix 1 of the Canadian Patent Act in 2006, a requirement for a compulsory license.

The reaction wasn’t any easier this time around, Fulton said: The company has come across separate phone numbers on the government website and broken URL links, and when it reached officials, the conversations below didn’t stir much coronavirus vaccines into the Got list included in Schedule 1.

However, there was a breakthrough last Tuesday when Biolyse and Bolivia announced they were signing an agreement to manufacture 15 million cans of the Johnson & Johnson batch under a compulsory license.

Of course, the company still has a long way to go before the production line can be up and running at its Ontario facility. In fact, only once in the history of the WTO has a compulsory license for the export of a medicinal product to a country with no manufacturing capacity been issued.

“We can expect a bureaucratic process that can be very complicated,” admitted Bolivia’s Foreign Minister Rogelio Mayta when the agreement was signed. But the government cannot just give up, he said: “We cannot be blind or silent about what is happening.”

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