The structural barriers to a faster and more equitable COVID-19 vaccine roll-out go far beyond the issue of patents, declared two of the world’s leading vaccine researchers and pharma execs at a WHO event on Monday evening. 

Sarah Gilbert, developer of the Oxford/AstraZeneca vaccine and Özlem Türeci, chief medical officer of BioNTech, the developer of the cutting-edge Pfizer-BioNTech mRNA vaccine, were speaking at a WHO media event honouring women in global health on the occasion of International Women’s Day. 

But their statements about the challenges of vaccine distribution – made at the tail end of a WHO press conference – illustrate a certain disconnect between WHO Director General Dr Tedros Adhanom Ghebreyesus’ recent offer to act as a “matchmaker” between pharma innovators and manufacturers to ensure faster production and more equitable distribution of new COVID jabs – and the hard-nailed infrastructure and logistical challenges actually faced – which are not a traditional area of WHO expertise.

Free IP Won’t ‘Go Anywhere Close’ To Solving Problem 

Asked by a reporter about WHO’s COVID-19 Technology Access Pool (C-TAP) initiative, which has sought to involve pharma manufacturers into a patent pool – to share IP on COVID vaccines and other health technologies, Gilbert replied, “I have to confess I’m not familiar with that initiative, I’m sorry.”   

Gilbert added:  “I don’t think that just making IP freely available goes anywhere close to solving this problem, because it’s not just to the right to use the technology that’s needed, it’s the feedstocks, the  cell banks, the protocols, the assays, the standards, the reagents to do everything. 

“This requires a great deal of support from the first company that licensed the vaccine, and this can be done, but it can’t be done in a completely unlimited way. 

“So we have to recognize that it’s important we have many vaccines to use across the world: those that are licensed Now, those that are still in clinical trials and will be approaching licensure. We want to see a good range of vaccines, ideally using different technologies,  because that will increase the chance of having the largest number of doses available. 

“And then what we need is that once those vaccines are manufactured, licensed and distributed, the ones that are sitting in vaccine centers actually get used to protect people and we don’t let them sit there going past their expiry date.”

Gilbert also stressed that Oxford’s R&D philosophy has always been that:  “we wanted to have a vaccine for the world, and we wanted it to be manufactured and distributed widely. And we’re very pleased to see that that is being done with many sub-licenses to different manufacturers in different parts of the world – increasing the number of doses of the vaccine that we initiated development of, have now been made available across the world.” 

Novel mRNA Vaccine Technologies Require New Manufacturing Setup – Repurposed Facilities Not Good Enough 

Dr Özlem Türeci, co-founder and Chief Medical Officer of BioNTech, and the developer of the Pfizer-BioNTech COVID-19 vaccine, echoed Gilbert’s remarks saying:  “Yes, I can only echo what Sarah has pointed out, so it is a comprehensive solution and approach we need. 

“Also, in particular if it is about novel platforms and novel technologies for which even the setup of production facilities need to be expanded, and you cannot just repurpose existing facilities. So patents are one thing but there are so many other things we have to ensure.”

The Oxford/AstraZeneca’s developers have pledged to sell the vaccine on a not-for-profit basis for the duration of the pandemic.

Despite that, the company’s executives  have so far not explained why one of their key licensees, the Serum Institute of India, has been selling the Oxford/AstraZeneca vaccine to South Africa and Uganda at 2-3 times the price of the vaccine in Europe – where the European Union procured it for around US$ 3 a dose.

The Oxford/AstraZeneca vaccine is also the leading product being used in the initial rollout of vaccines by the WHO co-sponsored COVAX initiative – with the first doses of the COVAX rollout having reached the first three countries in Africa, Ghana, Cote d’Ivoire and Ghana, just last week. 

Pfizer/BioNTech, meanwhile, is marketing its  vaccine at for upwards of US$25 a dose, although Pfizer recently offered some 40 million doses of the cutting edge mRNA vaccine to the WHO co-sponsored COVAX initiative at cost. Uptake of the Pfizer vaccine in low and middle income countries is, however, limited by the vaccine’s cold-chain requirements storage at -70 C.  

The remarks coincided with a two-day Global C19 Vaccine Supply Chain & Manufacturing Summit, a closed door forum sponsored by the UK-based Chatham House, in which pharma leaders and global health experts and research institutes are meeting to discuss ways to unlock existing vaccine supply bottlenecks.

Image Credits: @WHO.