There are 76 vaccine candidates for COVID-19, five of which are in clinical trials. It will take at least 18 months to determine if these vaccines are effective and safe enough to distribute en masse. Then, distributing them to millions of people will require an incredible feat of manufacturing.
But it can take five years to spin up a new manufacturing facility, says Paul Hudson, CEO at the pharmaceutical company Sanofi, which is working on a vaccine candidate, a potential treatment called Kevzara, and a home diagnostic test kit for COVID-19. To address this problem, the company is looking at how it can use existing manufacturing space to ramp up COVID-19 vaccines.[Photo: Jean Chiscano/Sanofi]“We’re looking at stopping making some vaccines to make [room] for COVID-19,” he says. “To plan long-term you do need a warm facility that’s ready to go, that has got experts in it, that you can then start producing hundreds of millions of doses in months.”
Before the COVID-19 outbreak, Sanofi had been working with the Biomedical Advanced Research and Development Authority on developing increased vaccine manufacturing capacity in preparation for a flu pandemic. Now it’s one of several pharmaceutical companies working with the agency on ensuring manufacturing capacity for COVID-19 vaccines. In this public-private partnership, BARDA pays for companies such as Sanofi to build out vaccine development and manufacturing. Under the deal, the department would have access to Sanofi’s production facilities for 25 years. The investment would enable Sanofi to pump out between 100 million and 600 million vaccine doses.
BARDA’s plan for scaling vaccine manufacturing during a pandemic may become something of a model for the rest of the world. Vaccine manufacturers typically only build out enough production to meet demand. To convince them to create excess manufacturing facilities in preparation for an infectious disease such as COVID-19, the government has to cover the expense. The government pays for it because pharmaceutical companies may ultimately never use it, Hudson says.
The biggest question mark attached to this model is how the government and manufacturers will keep the facilities in operation when a pandemic isn’t going on. Infectious diseases are unpredictable, and it’s never quite certain when one might emerge, so manufacturers and the government need a way to have manufacturing power on hold. “How do all the companies keep it warm and use it, so that it’s ready to be diverted to the next pandemic? That’s the trick,” says Hudson.
Hudson says that one way to keep the facilities in operation is to allow companies to share them. “You build it and then you allow a small percentage of our capacity and other companies like GSK—you have everyone put 10% of their capacity into it, so that if there is a pandemic then everyone steps out,” he says. When a pandemic strikes, the government can then start preordering vaccines to jump-start production.
If that plant had existed in the U.S. we could have made 100 million doses in the first 30 days from a sequence of a virus.”
Stefan Bancel, Moderna
In a conversation with MIT’s Laboratory for Financial Engineering in April, Moderna CEO Stefan Bancel said such an arrangement is critical to being prepared for the next pandemic. “If I had a magic wand for what I would like the world to do on the other side of this pandemic, [we would] invest in a very large plant where we could potentially make 150 million doses per month,” he said. “If that plant had existed in the U.S. we could have made 100 million doses in the first 30 days from a sequence of a virus. That would be extraordinary.”
Moderna is one of only a few companies that has been able to move a COVID-19 vaccine candidate quickly into phase 1 clinical trials. Bancel said his company was able to do that because Moderna was already spending a lot of time and money researching a coronavirus.
“Why was Moderna so fast to the clinic? Because we spent 18 months on MERS,” Bancel said. “I’m not sure if we had not worked on MERS that we could have gotten to the clinic so fast.” He says a critical component of preparing for a future pandemic will be investing in preclinical work on viruses with no vaccines, such as Nipah and Zika.
In the meantime, the pharmaceutical world will be focused on ramping up manufacturing. But the capacity might be unevenly distributed. Hudson says that the U.S. is building the majority of the COVID-19 vaccine manufacturing facilities, and he’s concerned that Europe doesn’t have enough.
“We have to think about how we manufacture the vaccines for Europe and the rest of the world. It’s going to be important to have capacity everywhere.”