Developing a vaccine only the start

The race to develop a vaccine for coronavirus has become one of the biggest scientific endeavours in history, but even once a jab has been proven to work, manufacturers will still face a mountain to climb.

Manufacturing a vaccine under normal circumstances is estimated to take an average of two years, and requires numerous raw materials such as sera, salts and syringes, while also being subject to rigorous quality controls. Even for seasoned players, such as Glaxosmithkline, the world’s largest vaccine manufacturer, building facilities at scale can take years. GSK expects the US$100M (NZ$165M) facility being built to produce its shingles vaccine Shingrix to take at least half a decade. ‘‘Vaccine manufacturing is one of the most complex, challenging and highly regulated areas of the pharma industry,’’ says Peter Welford, a healthcare analyst at Jefferies.

‘‘Producing any vaccine at scale is not trivial; the challenge of producing one with likely global demand on an accelerated basis, even if it has a relatively simple manufacturing process, shouldn’t be underestimated.’’

At the University of Oxford, scientists have already begun conducting human trials for a vaccine, which some experts believe has the most potential to succeed. The university has struck a deal with Astrazeneca, the UK’S largest drugmaker, to ensure its vaccine can be manufactured at scale.

But Adam Barker, an analyst at Shore Capital, believes that the challenges extend further than the ability to scale-up manufacturing. Tight regulation and quality controls will be one of the biggest hurdles, he says. ‘‘Even though all the protocols and procedures associated with manufacturing a vaccine have been developed for things like flu, we don’t have them for this virus because it differs for every vaccine,’’ he says.

‘‘There’s no shortcut for that and it’s one of the reasons vaccines is such a consolidated healthcare analyst at Jefferies.

market because there are these barriers to entry.’’

He adds: ‘‘Because we’ve never actually manufactured one at scale we just don’t know what quality control looks like.’’

Bosses at some of the world’s largest vaccine manufacturers including Glaxosmithkline and Pfizer admit more than one vacall cine will be needed to supply billions of people globally.

GSK and French rival Sanofi, which combined have the largest vaccine manufacturing capability in the world, joined forces last month in an effort to deliver ‘‘hundreds of millions’’ of doses to patients by as early as the second half of next year.

One of the ways in which GSK believes it will have an edge over its competitors is with the use of its adjuvant technology. Adjuvants can be added to vaccines to provoke a stronger and longer lasting immune response, reducing the amount of antigen needed and thereby reducing the amount of doses needed per person.

Meanwhile Astrazeneca believes its manufacturing and distributing capabilities could enable the University of Oxford to deliver a vaccine of up to 100m doses by the end of 2020.

‘‘Vaccine manufacturing is one of the most complex, challenging and highly regulated areas of the pharma industry.’’

Peter Welford