COVID-19: Q&A on vaccine manufacturing capacity

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March 20, 2020

HRI spoke with PwC principal Omar Chane about pandemic vaccine manufacturing capacity in the US as it relates to the COVID-19 outbreak. [Note, this information was last edited on March 19, 2020.]

PwC Health Research Institute (HRI)

Anthony Fauci, director of the National Institute of Allergy and Infectious Disease (NIAID), has estimated an 18-month timeline for vaccine development, but what about the timeline for being able to manufacture a vaccine at commercial scale? How long could that take?

Omar Chane, Principal, PwC Health Industries

You have to start by asking what is the underlying technology we are using to develop the vaccine antigen. We’ve seen a few manufacturers that have said they are developing a vaccine, but they’re using different technologies. Some are using a recombinant protein approach and some are using an mRNA-based approach.

A protein-based approach will take a while to get to a candidate that can be tested in clinical trials, while at least one manufacturer using the mRNA-based approach already has a candidate that has started clinical trials.

However, with an mRNA vaccine, we’ve not yet had any vaccine approved for any disease that uses that technology, so we don’t know how long that could take to manufacture.

The good news about mRNA vaccines is that the investment required to manufacture the bulk product is less than with more traditional approaches like egg- and cell-based, which take three to five years to build up the facility and $500 million to $600 million to build it.

HRI: What happens after bulk manufacturing?

Omar Chane: Then you need the facilities to fill and pack it. While the bulk product will have to come from the manufacturer that owns the intellectual property, you can use other companies to do the secondary manufacturing for formulation, fill and pack.

HRI: Have we invested in influenza pandemic vaccine manufacturing at all, and can we borrow from that for a potential COVID-19 vaccine?

Omar Chane: We’ve seen some investment by the federal government for pandemic influenza vaccine manufacturing. The Biomedical Advanced Research and Development Authority (BARDA) announced a $226 million contract with a manufacturer last year.

But from a bulk manufacturing perspective, that wouldn’t necessarily help with something like an mRNA vaccine. We’ve also got egg-based platforms, but we can’t leverage those with the COVID-19 vaccines that are being developed right now.

HRI: Are there efforts underway to take a platform-agnostic approach to build up pandemic vaccine manufacturing preparedness?

Omar Chane: Two things have happened recently that could help. First, last year, the government reauthorized the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPA), which allocates billions to pandemic preparedness that could be used for building up capacity, whether it’s egg based or protein based is not yet decided. PAHPA reauthorizes $1.2 billion annually over the next five years for BARDA and the Strategic National Stockpile.

Most recently is the $8.3 billion emergency funding package for the coronavirus outbreak, which included $3.1 billion to support the development of countermeasures and vaccines.

However, one thing is certain: In order to address and contain a pandemic, we need a combination of therapeutics to manage the immediate medical needs triggered by any pandemic, and we also need a vaccine that will provide longer-term protection. Neither one of these measures will be sufficient alone.

HRI: How are or what should pharmaceutical and life sciences companies be thinking about the COVID-19 outbreak from a vaccine manufacturing perspective?

Omar Chane: The big question that’s going to come up now is, what’s going to happen with this virus? Is it just going to take its course and disappear? Or is it going to become another kind of infectious disease that we’re going to need to address on a seasonal or endemic basis?

If you look at the MERS outbreak, it took its course but it has not become a recurring disease that required a more formal approach to immunization.

A lot will depend on what happens over the next two to three months in terms of will this go away the same as these others or will it become an endemic issue?

HRI: If it goes away, does it reduce incentives to build pandemic manufacturing capacity?

Omar Chane: If it goes away, that doesn’t mean that it’s never going to come up again. But it will be up to the government to say, do we want to be prepared in case of another outbreak? One possibility is that the government behaves the way they do for pandemic influenza.

If you look at pandemic influenza, some countries have chosen to invest in building local manufacturer capacity so that if there is a global pandemic, they can have local manufacturing.

Countries like the US do stockpiling for influenza vaccines, where they look at the riskiest strains and stockpile for those. Some other countries rely on other measures to manage pandemic outbreaks.

However, one thing is certain: In order to address and contain a pandemic, we need a combination of therapeutics to manage the immediate medical needs triggered by any pandemic, and we also need a vaccine that will provide longer-term protection. Neither one of these measures will be sufficient alone.
 

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Omar Chane

Principal, PwC US

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