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Which GMP manufacturing plants will produce the Covid-19 vaccine?

The race, the prize
So right now nobody has a Covid-19 vaccine that is proven to work and proven to be safe. There are more than 115 candidate vaccines in development and there are several very different vaccine technologies being explored which would require very different types of manufacturing plant. The revenue prize is huge, hence you have huge investment from enormous Western and Asian life science companies to try and get a solution to market quickly. It is unlikely that one company will be capable of producing enough vaccines to treat the 7.8 billion people on earth, and so it is likely there will be several winners sharing the prize. So spoiler alert  – I can’t tell you now which existing plants will produce which vaccines, but we can certainly explore what is required and which plants might be suitable, as well as some of the factors in consideration.

For the layperson (me), here is a simple summary of candidate vaccines currently in Phase 1 or Phase II trials – don’t forget that it may be none of those currently in trials that succeeds and we have to wait for one of the others from a total of 115 candidates to come to trials. As mentioned, it is likely that we will end up with more than one vaccine that proves suitable and enters production.

So right now plants are already preparing to produce relatively small quantities (only millions!) of the vaccines that are currently in clinical trials for initial “emergency use”

Great, so now produce 7.4 Billion doses
Of course there is a great difference in producing doses at the scale required here. You are talking about gearing up plants to produce maybe 500,000 doses per quarter which is quite a challenge. Let’s look at the types of production facilities required

Adeno Virus and Gene Therapy
If you look at the candidate vaccines many are adeno virus vectors or some variation of same. The detail of this technology is complex, but let’s simplify massively and  you can say these vaccines need to be grown inside host cells. So you need access to large biotech facilities where you can produce large batches of these cells and then complete the extraction process before sending the final vaccine for fill/finish which may be on another site. All of this takes time but you can produce these products at scale. There are only certain organisations that have the sort of mega facilities to produce these vaccines at a rate of multiple billions of doses per year

mRNA Production
This is a very different technology. The mRNA vaccines are fully synthethic, and so can be produced at scale very quickly. Unlike the protein based vaccines it does not have to be grown in cells and then purified. In the West, there are only really four enterprises that have this technology, and each of those four organisation have existing partnerships with big pharma. This is set out clearly here.  All four of the prominent western mRNA businesses have Covid-19 vaccines in development and will be backed by big pharma for funding and to bring the products to market. CureVac, BioNtech, Moderna, eTheRNA all have their own very specialised production facilities but do have the ability to scale production relatively quickly if they have a successful vaccine candidate. China’s Cansino Biologics also has an mRNA vaccine in phase two trials already. The detail of the equipment these organisation have to produce the mRNA is closely guarded, all of these organisations have expensive IP to protect.

Jostle for Production Capacity
So right now you have an interesting situation where suitable facilities are being lined up to produce vaccines, but currently they cannot be certain which vaccine they may be required to produce. Once a deal has been done and preparation starts, you still obviously have a huge amount of work to do to reconfigure a facility and go through qualification to produce commercial batches.

In the background then, there are manoeuvres and negotiations regards bringing online the mega plants that can produce the vaccines in the quantities required. This is all very complicated and high risk because the amounts of investment required to line up production capacity is vast, whilst we don’t have a successful vaccine. Also we don’t know what the virus and geopolitical situation will be in 2020. If one of the three Chinese candidate vaccines turns out to be successful, will they be able to get it in to production very fast?  What we can say though is that despite all these challenges, you can see many of the top life science companies pursuing the development of a vaccine.

Some of the Contenders

Moderna has a mRNA vaccine in phase II trials and whose effort is being funded by the US government BARDA.  Moderna opened a state of the art therapeutics plant in Norwood, MA on the edge of Boston in 2018. Using this investment from BARDA, Moderna is planning on getting more mRNA production machines and increasing the output of existing machines.

J&J Janssen through an existing partnership with the US government BARDA organisation is gearing up to produce 1 billion doses of a Covid-19 vaccine in Q1 2021. This is obviously a huge challenge in re-configuring the processes, the control systems and getting through qualification in the timescale. Read more here.

Pfizer has multiple initiatives, most prominent of which is that Pfizer have advanced German company BioNtech $185M for access to their mRNA based solution. They say this product could potentially be available by end of 2020, and Pfizer has some of the largest production facilities in the world in its arsenal.

SinoVac Biotech of Beijing has a vaccine in clinical trials in China and will look to scale production quickly  and licence the technology to Western partners. The Chinese government has backed Sinovac with a loan to build a new production facility to produce their vaccine.

Sanofi already produces about a billion vaccine doses a year and has entered more than one alliance. Sanofi are collaborating with GlaxoSmithKline to share the risk on putting in place the capacity to produce a billion does a year of a Covid-19 vaccine

So there are many runners in the race and the prize can be shared. By Autumn 2020, we should have a clearer picture of the likely winners. We do know that there are many challenges and the amount of investment required is enormous, nonetheless it is likely to be late 2021 and in to 2022 before vaccines at low cost are readily available to the poorest people on earth