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As much of the world remains starved for coronavirus vaccines, a group of companies is offering to partner with larger drugmakers as one way to rev up production. But they’re getting the same answer: No thanks.
Biolyse in Canada, Incepta in Bangladesh, Teva in Israel and Bavarian Nordic in Denmark have all asked to assist in the manufacture of vaccines. As yet, none has a deal.
This reluctance to merge forces is even more puzzling given Big Pharma’s line that current production capacity is to blame for vaccine under-supply. It’s this reasoning that drugmakers cite to counter arguments in favor of waiving intellectual property for vaccines — a movement that got a jolt last week when the U.S. gave rhetorical support to the idea.
“[Europe’s] focus should remain on creating the partnerships and investing in facilities to increase capacity to meet the needs of citizens across Europe [and] around the world,” said the European Federation of Pharmaceutical Industries and Associations’ Director General Nathalie Moll after the U.S. announcement.
Many European policymakers have also reiterated this line. “The limiting factor in vaccine manufacturing is production capacity and high quality standards, not patents,” said a spokesperson for German Chancellor Angela Merkel.
Yet recent history shows numerous examples of industry turning down offers of help from other drugmakers — citing the complexity of the process, safety concerns and lack of time to carry out technology transfer.
These willing partners are companies that, collectively, have a global presence and in principle the capacity to produce millions of doses.
Teva, for example, is the largest manufacturer of generic drugs in the world. CEO Kåre Schultz said earlier this year that it was looking to help manufacture some of the vaccines that have been approved or are about to be approved.
Canadian drugmaker Biolyse — which manufactures sterile injectable medicines — is smaller, but it says it has the potential to produce 50 million doses a year of any vaccine once approved. According to John Fulton, one of its consultants, if it had gotten the green light a year ago, it would have taken the company six months to be up and ready to produce vaccines — and now would be halfway through a year’s production. It has contacted several different companies producing vaccines, including Johnson & Johnson and AstraZeneca.
Meanwhile, Bangladesh’s Incepta is already producing several non-coronavirus vaccines for export. Incepta’s chairman and managing director, Abdul Muktadir, has said that Incepta can manufacture bulk antigen for coronavirus vaccines using almost all of its technology platforms. In a March interview with Geneva Health Files, Muktadir said that the easiest vaccine technologies for them to produce would be protein subunit, used in the Novavax jab, and mRNA products, which include the jabs produced by BioNTech/Pfizer and Moderna.
If the antigen was already provided, he said, “production can start immediately,” as Incepta has several lines sitting idle. With just one of these lines, Muktadir estimates Incepta could fill vials for about 500 million doses a year.
The government in Bangladesh issued a request to AstraZeneca to allow Bangleshi companies to help produce the Oxford/AstraZeneca vaccine, according to local media. That request remains pending, as it’s unclear whether the Directorate General of Drug Administration’s laboratory meets global standards to export vaccines.
Over in Denmark, biotech company and vaccine manufacturer Bavarian Nordic is also holding out hope of securing a deal. In an email, a spokesperson said it’s in contact with most of the developers of approved coronavirus vaccines, as well as those with vaccines that are close to market. “We are discussing how we in the best way possible assist with manufacturing and or filling of vaccines,” said the spokesperson.
Thanks, but no thanks
In many of these cases, the vaccine developers who were contacted said they already had sufficient partnerships to produce vaccines.
According to Fulton, Johnson & Johnson told Biolyse it “had adequate production capacity with the companies that they engaged with.” As for the other vaccine developers that Biolyse reached out to, including AstraZeneca, none was interested in its help, said Fulton.
Teva and Incepta, for their part, both attributed the rejection of their offers for help to vaccine makers’ preference to go with either contract manufacturers or other large pharmaceutical companies.
“We really wanted to help if we could,” Teva’s Schultz told Bloomberg. “The companies … we were in contact with went for classic contract manufacturers, or they went with big pharma companies for partnerships.”
Incepta’s Muktadir has a similar view: “Innovator companies are at ease working within their comfort zone and do not want to deal with unknown companies.”
For their part, vaccine developers explained their rejections by citing the highly complex process of producing vaccines and the need for safety — implying that some potential partners may just not be skilled enough to produce the jabs.
“This is a complex biological process that relies on complex supply chains for raw materials and distributing the finished product, as well as on the yield returned from batches,” said an AstraZeneca spokesperson. “And above everything, patient safety must always come first.” AstraZeneca currently has over 20 supply partners.
Johnson & Johnson also pointed to the complexity of the process. There’s a “limited number of manufacturers with sites capable of producing the necessary volume of high quality, and safe vaccines necessary to address this pandemic,” a spokesperson said, adding that Johnson & Johnson has assessed nearly 100 different sites and now has “several manufacturing collaborations.”
As for the BioNTech/Pfizer vaccine, the majority of doses come directly from their own facilities. But the German-American duo also has partnerships with over 15 contract manufacturers helping with production, said a spokesperson.
According to AstraZeneca’s CEO Pascal Soriot, there’s another reason why vaccine developers can’t bring on new partners — they’re too busy.
With vaccine developers working around the clock to develop and manufacture vaccines, Soriot attests their engineers just don’t have the time to train more people in production.
“Even if we give access to the technology and we told people, ‘Here is the recipe,’ there is no way we could train these people to manufacture the vaccine because our engineers are flat-out working with our existing partners,” he said in early May, according to Business Insider.
There’s another motive at play behind these rejected offers, according to James Love, director of Knowledge Ecology International, which has advised Biolyse: “Vaccine manufacturers want to control pricing and distribution of their products, and most don’t want to freely share know-how,” he said.
The problem is that the global urgency for ramped-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 all said that they have facilities that could possibly be retooled to produce coronavirus vaccines.
Manufacturers need to “take a[n] honest look” to see if they can be matched with other companies who could produce their jabs, she said.
Pharmaceutical companies need to “move quickly instead of resisting,” she added. “They need to be going in and putting their hands up and saying … ‘we are ready to work with you in Bangladesh, we are ready to work in Pakistan.'”
Going it alone
For Biolyse, these rejections aren’t the end of the road. If it can’t work with a vaccine developer, it can go it alone through a compulsory license. It’s a route Biolyse previously took during the 2006 outbreak of H5N1 with Roche’s influenza drug Tamiflu. By a stroke of luck — and extensive legwork — Biolyse got the generic of Tamiflu added to Schedule 1 of Canada’s Patent Act in 2006, a prerequisite for a compulsory license.
The response this time hasn’t been any easier, said Fulton: The firm has bumped up against disconnected phone numbers on the government’s website and broken URL links, and when it has reached officials, the ensuing conversations haven’t led to much movement in getting coronavirus vaccines added to the Schedule 1 list.
But there was a breakthrough this past Tuesday, when Biolyse and Bolivia announced that they’re inking an agreement for 15 million doses of the Johnson & Johnson jab to be produced under a compulsory license.
To be sure, the company still has a long way to go before it can get the production line started in its Ontario facility. In fact, only once in the WTO’s history has a compulsory license for a medicine being exported to a country lacking manufacturing capabilities been issued.
“We can expect a bureaucratic process, a process that can be very complicated,” admitted Bolivia’s Foreign Minister Rogelio Mayta during the signing of the agreement. But the government can’t simply give up, he said: “We can’t be blind or silent in the face of what is happening.”
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