The process of manufacturing viral vector and whole virus vaccines presents a challenge to President Joe Biden’s plans to ramp up production by waiving patent protections for COVID-19 vaccines.
Biden floated the idea last Wednesday, angering pharmaceutical companies in the process. Supporters of the proposal believe it would remove a major obstacle to letting the developing world manufacture generic versions of vaccines.
But the impediment may not be intellectual property rights but rather a lack of facilities and expertise.
“There are not that many places that are fully operational and have the human resources that are qualified to operate this kind of technology,” said professor Amine Kamen, the Canada research chairman in bioprocessing of viral vaccines at McGill University.
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A viral vector vaccine uses a “cold virus” combined with spike proteins from a coronavirus, while a whole virus vaccine uses the entire coronavirus. According to research published in March, viral vector vaccines account for 22% of COVID-19 vaccines, while whole virus vaccines account for 35%. Makers of viral vector vaccines include Johnson & Johnson and AstraZeneca, while Chinese drugmakers Sinovac and Sinopharm produce whole virus vaccines.
If a facility isn’t already set up to produce such vaccines, as is the case in much of the developing world, getting it equipped to do so takes time.
“You want to put the process on an existing facility rather than building a facility from scratch,” said Zoltan Kis, a chemical engineer at the Future Vaccine Manufacturing Hub at Imperial College London. “Normally, without a pandemic, it would take about two years before [you are making vaccines]. In the pandemic … it could take six months to a year, and that is being optimistic. It could easily take over a year.”
One step that lengthens the time involves growing enough viruses. During the manufacturing process of viral vector and whole virus vaccines, a protein called “e1” is removed from the virus to prevent it from replicating in the human body. However, enough of the virus must be grown during the manufacturing process to produce millions if not billions of vaccines. To achieve this, human cells are grown in an industrial bioreactor and mixed with the virus. The human cells are engineered to contain the e1 protein, which enables the virus to replicate.
“It’s a process that relies on cell culture on an industrial scale, and it is tricky,” said Derek Lowe, a pharmaceutical researcher for 30 years who writes the In the Pipeline blog at Science magazine.
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Lowe’s wife used to work on cell culture, and he said that she described it as “the worst pet you ever had. The cells are alive, they’re growing, they have to be fed, they have to have their waste products rinsed out, and even the people doing it on an industrial scale can have trouble.”
It takes about two months to grow enough human cells, and it is easy for the process to go wrong.
“It is hard to predict ahead of time that things will go wrong, and you might have to wait until the late stages that something went wrong. And then, you have to start again,” said Kis.
Once enough vaccine has been grown in the cell culture, it has to be filtered, and the proper filtration materials are currently in short supply.
“This is why I get frustrated about the idea that waiving the patent will suddenly open the floodgates [for COVID vaccines] because these supply problems have nothing to do with patents,” said Lowe.
Also lacking in much of the developing world is the expertise needed to run the manufacturing process. And right now, that is also in short supply.
“You don’t usually have a lot of trained experts just hanging around,” said Kis. “And now, with the pandemic, expertise is even further stretched.”
Training people in the developing world to manufacture viral vector and whole vaccines would take time. But how long depends on many factors. If they have already worked in the vaccine field, it would take less time. But if not, then getting the qualifications to do it could take months, according to Kis.
To see how long the transfer of technology and expertise would take at a minimum, Lowe suggested watching the deal between Johnson & Johnson and Merck. In March, Merck agreed to upgrade a plant in North Carolina to make the Johnson & Johnson vaccine.
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“It’s not clear how long it will take, but we are talking months,” Lowe said. “It’s not going to happen any faster.”
