A two-day summit of the world’s top pharma and public health sector players to address COVID-19 vaccine supply chain and manufacturing bottlenecks ended on Tuesday with agreement that large vaccine manufacturing scale up potential exists – even in 2021 – but the route is complex and there are no easy fixes. 

And most immediately, there are  “increasing signs of strain within supply chains” as vaccine manufacturers scramble to procure some of the same raw material inputs and equipment, said. Richard Hatchett, CEO of the Coalition for Epidemic Preparedness (CEPI), which has seeded key  COVID-19 vaccine R&D investments, which are now driving the global vaccine distribution platform, COVAX.  

“Companies are beginning to report shortages of critical raw materials, critical consumables, even equipment, that is necessary for vaccine manufacturing,” said Hatchett, at the close of the summit, hosted by the UK-based Chatham House.

He pointed out that the usual global production of vaccines was between 3.5 – 5.5 billion doses whereas the aim for this year was to produce 14 billion COVID-19 vaccines.  A background paper produced out of the summit discussions  “Towards Vaccinating the World” provides one of the most detailed papers to date on the landscape of current vaccine supply chain bottlenecks, manufacturing challenges and possible solutions.  

The paper warns that already “it has become apparent that many COVID-19 vaccine input supplies of raw and packaging materials, consumables and equipment are in short supply which may result in several COVID-19 vaccine manufactures not being able to meet their current vaccine manufacturing commitments.

“Such shortages will also impact the ability to manufacture other lifesaving vaccines and biologics. Mechanisms to ensure input supplies for current and increased manufacturing capacity intent need to be put in place with short, medium and longterm solutions.”

Largest Ramp-up of Vaccine Manufacturing World Has Ever Seen

Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers (IFPMA) added that few people fully understand the scale of the task at hand. 

“This is the largest ramping up of manufacturing the world has ever seen,” said Cueni. “I have to admit to myself, if you would have asked me three months ago, I would have said there is no idle capacity. Everybody is already doing the maximum of that they can.

“But just over the last few weeks, we have seen new players, experienced players in pharmaceutical manufacturing coming in. We have also seen an amazing amount of collaboration and togetherness, for example, between innovative manufacturers and developing country manufacturers.”

Cueni said the meeting delved into granular detail about the kinds of technology transfers would be needed to fast-track vaccine manufacturing – pointing to the importance of being able to move skilled workforce around, political will and regulatory harmonisation. 

“I think we all extremely grateful for the incredible work regulators do. It is amazing how fast we saw safe and effective vaccines approved,” said Cueni.

Technology Transfer For Vaccines More Complex Than for Chemical Compounds

While access groups have focused in great detail on the issues of patents and IP as a barrier to rapid manufacturing scale-up, the summit participants stressed the ways in which knowledge transfer and the presence of a skilled workforce are preliminary requirements for any expansion of capacity – along with sensitive and sophisticated infrastructure needs.

“Unlike pharmaceuticals which are chemistry-based products, the complexities of biological vaccine operations are still of higher challenge,” said Rajinder Suri, CEO of the Developing Countries Vaccine Manufacturer’s Network (DCVMN).

“You have a drug substance, … you have a drug product. And then you have the final fill and finish. So at the drug substance level itself, there are several complexities which are involved, whether it is in terms of platform technology; whether it is in the form of capacity,… so there are so many issues which one has to really understand, before getting into the tech transfer. And then, matching the scaling up of the facility, whether in terms of fill and finish, or final product.

“Again, this has to be fully understood before getting into this kind of a tech transfer agreement with other companies or other countries. So, the ability of an individual company to absorb technology and have trained manpower to really understand what are complexities and how to take it forward, are also going to be the key challenges.”

Developing Vaccine Manufacturing Capcity in LMICs – Long Term Goal

And while developing vaccine manufacturing capacity in low and middle-income countries was important, said Cueni, this was a long-term goal.

The most immediate challenge is to simply find ways for the world to produce more COVID-19 vaccines – and that meant looking at every corner of the planet “where you have the know-how, expertise and equipment.

Sai Prasad, President of the DCVMN, agreed, saying: “With COVID-19, we need to ensure vaccines as soon as possible so for 2021 and 2022, we need to go where there is existing capacity, human resources and know-how”.

Prasad also added that technology transfer was “less about intellectual property and more about knowledge transfer”.  He was referring to the South African/Indian joint proposal for an intellectual proper waiver on COVID-19 related health technologies, not before the World Trade Organization – which advocacy groups say would unlock supply bottlenecks.

Rasmus Hansen from research company AirFinity added that manufacturers also were concerned about “a mismatch between supply and demand” – in which ramping up too fast might even create excess capacity.

“Will we get to a point of over-supply?” asked Hansen. He said that manufacturers that were considering expensive and technologically complex investments in vaccine production, were also asking what their level of long-term investment should be.

Meanwhile, Hatchett said he was concerned about the potential for the United States to use its Defense Production Act to reserve scarce vaccine ingredients for its own use, saying this, too, would “disrupt vaccine manufacturing” at a more global level.

Summit Was Not About ‘Matchmaking’ and there were ‘No Blind Dates’  

Cueni said that while “everybody who was at the summit, is keen to follow up, this summit was not a dating meeting.”

His comments were a direct rebuttal to a WHO statement last week by Director General Dr Tedros Adhanom Ghebreyesus that the global health agency stood ready to play “matchmaker” between pharma innovators and manufacturers in order to increase vaccine production more  rapidly.

“There were no blind dates or things like that,” he said noting that the virtual nature of such a summit and the legal constraints companies already operate under would discourage “matchmaking” in particular.

At the same time, he said he is optimistic about the potential of seeing more partnerships evolve that can address the global bottlenecks seen now.  ” I do expect  we will see more partnerships, we will see more surprising announcements about new capacities found,” declared Cueni.

“But also we will see we will see the longer term dialogue about how to improve on tech transfer,” he added. “I think there’s a commonality of views I’ve already had discussions with several manufacturers from our side afterwards, and there’s a willingness to to engage in that.

“In terms of the tech transfer, it’s already happening though, and the expansion of capacity has taken place because you have partnerships, for example between innovative manufacturers and developing country manufacturers, both bringing their respective competencies competencies to the fore. But we also had of course, a number of high level government representatives there. I think also understood that they can help to address inefficiencies.”

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Image Credits: IFPMA .