Vaccine technology cannot be easily shared between manufacturers, says Oxford jab professor

The professor who designed the Oxford/AstraZeneca vaccine has challenged the suggestion that the technology and methods for producing the Covid-19 jabs can be easily transferred from one manufacturer to another.

Sarah Gilbert, a professor of vaccinology at Oxford University, said there were multiple challenges involved in exchanging vaccine ‘blueprints’ between pharmaceutical companies, from maintaining safety production standards at factories to ensuring high yields are maintained.

As calls grows for intellectual property rights to be waived, with the World Health Organisation notably calling on manufacturers to share their technology to “dramatically increase the global supply”, other experts have warned these proposals are “easier said than done”.

Many of the world’s vaccines are being produced by developed nations, which have already pre-ordered the vast majority of doses due to be delivered throughout 2021, leaving poorer countries scrambling for supplies.

Efforts to distribute doses to poorer nations through the global vaccine-sharing initiative Covax have meanwhile been disrupted by export bans, hoarding and worldwide supply shortages, leading to rising pressure for patent protections to be dropped.

But speaking with The Independent last month, Prof Gilbert said: “I’ve heard people say: ‘Give us the formula and we’ll make the vaccine in other places.’ But it’s not just the formula. That’ll be like giving someone a list of ingredients for cake and then they’ve got to work out what to do with them.

“What is needed to make the same vaccine in different companies around the world is for the parent company to work very closely to support all the sub-licensees with the protocols, the testing, all of the quality assessment procedures, and then work with those companies while they get their manufacturing processes set up themselves and support them.

“That’s been necessary as at some manufacturing sites, initially when they start running the process, the yields aren’t very good. Then with time and practice and support, the yields improve.”

AstraZeneca is already working with more than 20 partners across 15 countries to manufacture its jab, and has agreed to sub-license its product to both SK Bioscience, a South Korean pharmaceutical, and the Serum Institute of India, the world’s largest vaccine manufacturer.

These arrangements have not been without their challenges. In Europe, one factory in Belgium struggled at first with the complicated biological manufacturing processes that go into producing a new vaccine at scale, resulting in a lower output of doses and delayed deliveries to the EU.

Prof Gilbert said it was a “real problem” if the yields aren’t high enough, as this returns a smaller amount of doses from “the same raw materials needed to make a vaccine, all of which are becoming limited as we ramp up across the world”.

“If one company is only producing 10 per cent of the amount they should from that input, that’s a big problem.”

Some manufacturers in the global south have said they have the capacity and factories needed to help ramp up the production of doses, but that their facilities are lying idle and unused. 

These companies, alongside a number of governments, have called for the World Trade Organisation to waive a longstanding agreement designed to protect intellectual property, known as Trips, and allow the sharing of vaccine technology and manufacturing knowhow.

But Steve Bates, CEO of the UK BioIndustry Association, said that this approach wouldn’t necessarily accelerate the production of doses in the short or medium term.

“It’s easier said than done,” he told The Independent, explaining that new factories which are utilised for manufacturing have to undergo extensive regulatory checks and maintenance – a process that requires time, resources and manpower.

“If there was a production failure, because the site wasn’t regulated in a proper way, you’d have bad outcomes. Possibly adverse events, side effects and then compounding impact of knocking confidence on the vaccine,” he added. “There needs to be a plan for regulating the new sites.

“And if you’re learning in a new plant, your yields are unlikely to be as good as they are in sites that know what they’re doing for biological manufacturing processes.”

He said there was a “finite amount” of resources needed to make the Covid vaccines, from the “plastic bags that go in the bioreactors to the active pharmaceutical ingredients”.

“You have to make a call as to where do you put those ingredients and how do you best use them in a period of constrained supply. My view is that you’ll get more quality vaccines faster if you focus those supply chains on factories that know what they are doing.”