How to manufacture Covid-19 vaccines without the help of J&J, Pfizer or Moderna? Biolyse sees the difficulties up close
When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.
The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.
With an unwilling J&J, Biolyse then turned to the Canadian government to license the patents under a program called the Canadian Access to Medicines Regime, which allows the export of drugs and vaccines to low-income countries like Bolivia, with the hopes of bettering their responses to public health crises like HIV/AIDS, tuberculosis and others.
But for those drugs or vaccines to be exported from Canada, they need to be included in a list created by the Canadian government, known as Schedule 1, which is part of the country’s Patent Act.
So far, Canada has not added Covid-19 drugs or vaccines to that list.
“Blocking the listing on Schedule 1 is really bullshit,” James Love, director of the NGO Knowledge Ecology International, who’s been pushing to increase access to Covid-related vaccines and therapeutics, told Endpoints News. “It’s bizarre that Covid-19 is not considered a global health issue in Canada.”
A spokesperson for the Canadian government’s Innovation, Science and Economic Development program explained to Endpoints that it’s also not just about adding Covid-19 vaccines to Schedule 1.
“It’s important to note that adding a COVID vaccine to Schedule 1 would not allow a compulsory license for the production and export of these vaccines. A company seeking authorization under Canada’s Access to Medicines Regime must be able to manufacture the drug and conduct necessary trials to establish that the drug meets Canadian safety and efficacy requirements before authorization would be granted,” she said.
Biolyse’s EVP John Fulton told Endpoints that his company could reverse engineer the J&J vaccine from a couple drops from a vial, but the company would need J&J’s cooperation to run a trial and it will need additional government funds to scale up.
And while the government spokesperson said she’s “closely following the situation” between Biolyse and Bolivia, Fulton said the government has not been straightforward in explaining how to add Covid-19 vaccines to Schedule 1.
“I started inquiring in late February 2021 and still they won’t give me an answer on how to start the process,” Fulton said via text message. “I’ve had meetings with close to 30 different high-level officials and no straight answer on how to trigger the addition.”
Biolyse said in its agreement with Bolivia that it should be able to produce 200,000 doses per week, if it obtains the compulsory license.
But the odds of that occurring are low, because, as Fulton explained, it will require Canadian government officials to go out on a limb, and “spend the political capital and have the courage to wade into the geopolitical storm that will ensue when they signal they support the loosening of IP to vaccinate LMIC [low-to-middle income countries].”
Adding Covid-19 vaccines to Schedule 1 also would open the door for Biolyse and others to make not just J&J’s vaccine, but Pfizer and Moderna’s mRNA vaccines too, which further complicates the situation.
“150 different things need to happen for a CL [compulsory license] to be issued in Canada just on the export side,” Fulton added. “The TRIPS waiver streamlines this process on the importer side.”
Pfizer and Moderna have both made clear in recent weeks that they are not going to help any companies trying to make copycat versions of their products, especially as they would be vying for the same raw materials and necessary equipment.
And the Canadian government does not seem ready to budge, at least for now.
Instead, the spokesperson said the country will invest about $2.2 billion over seven years towards growing a vibrant domestic biomanufacturing and life sciences sector, while also providing $940 million in support for low- and middle-income countries to access COVID-19 vaccines, tests, and treatments through the WHO’s ACT-Accelerator.
So will Biolyse raise funds and move their operations to another country where obtaining a compulsory license and regulatory clearance might be easier?
No, according to Fulton, explaining that Biolyse has the requisite facility now, and adding a fill line to a new site would add between 18 months and two years to the entire process. But he also thinks that obtaining a compulsory license is about more than dealing with Covid-19 in the short term
“I think Covid will be with us for a long time, and I hate to say it, but we have the time. What’s happening in India could happen to us in Canada,” Fulton added. “If a compulsory license system can’t work now, during a worldwide pandemic, what’s it for? What’s the use?”