Konstantin Hondros & Milena Leybold

Is an open source vaccine inside?

Just over a year ago, Milena Leybold and Leonhard Dobusch asked, Why is there no open-source vaccine against Covid-19? and discussed arguments why open-source vaccines are difficult to achieve. In March 2022, The Financial Times published an article by Donato Paolo Mancini, Jamie Smyth, and Joseph Cotterill asking Will ‘open-source’ vaccines narrow the inequality gap exposed by Covid? (behind a subscription barrier) and indicating that the landscape of open-source vaccines may have changed substantially.This blog post is thought of as a reply and extension to this very informative report that introduces mainly two organizations producing or aiming to produce open-source vaccines: Afrigen Biologics and Vaccines (Afrigen) and the Texas Children’s Hospital Center for Vaccine Development (CVD with their vaccine Corbevax). For sure, Afrigen and CVD approach vaccine development, production, and distribution much more openly than most of the vaccines dominating the market. Still, it is unclear to what extent they should be considered as “open-source.” To clarify this topic, we scrutinize what an open-source vaccine ideally could be, to what degree Afrigen or CVD fit the ideals of open-source, and what other attempts for open-source vaccine alternatives are currently under development.

What are characteristics of an Open-Source Vaccine?

The online-resource opensource.com refers to open source as “something people can modify and share because its design is publicly accessible,“ a definition that already underscores that open-source has moved far beyond its original context of software development. They furthermore list characteristics that we typically encounter in open-source projects or organizations: “principles of open exchange, collaborative participation, rapid prototyping, transparency, meritocracy, and community-oriented development.“

More specifically with regard to open-source drug development, we can learn from Open Source Malaria (OMS), itself a very interesting project in open source pharmaceuticals that Suela Simoni already blogged about in January 2022. OMS follows six principles of open-source research:

  1. All data are open and all ideas are shared.
  2. Anyone can take part at any level of the project.
  3. There will be no patents.
  4. Suggestions are the best form of criticism.
  5. Public discussion is much more valuable than private email.
  6. The project is bigger than, and is not owned by, any given lab. The aim is to find a good drug for malaria, by whatever means, as quickly as possible.

There are communalities, but also differences between open-source characteristics and OMS’ six principles: The public accessibility resembles OMS’ open data approach, open exchange and collaboration are tackled by inclusion of “anyone at any time.” Collaboration is secured through being open for suggestions and a public discussion. From these perspectives, open-source software and open-source pharma are very close to each other. The product-oriented modifying and rapid prototyping is, however, missing in the pharmaceutical sector: regulatory constraints, which primarily consist in fixating a vaccine design to phase-trial, oppose any practice of rapid prototyping and, thus, constitute tough nuts for conducting open-source pharmaceutical R&D. Starting from here, we can now characterize whether Afrigen’s vaccine and Corbevax are open-source.

Is Afrigen’s vaccine open-source?

Going through OMS’ list of principles, Afrigen – though very informative to both journalists and scientists – to our knowledge does not make data publicly accessible to share it openly with everyone. Though there apparently exists a vaccine design, it has not been made public until now. Yet, after trials that progressed recently, Afrigen plans substantial technology transfers via a transfer-hub and licensing of the design with the medicines patent pool. Still, modifying or rapid prototyping does not seem feasible for others easily. Afrigen collaborates actively with several organizations, however, we did not find evidence that partaking in Afrigen’s activities, and the vaccine development is possible for “anyone”. As far as we are informed, Afrigen is not going to patent any knowledge emerging from their activities, or at least keep the knowledge available for others. The bullet point 4 is difficult to assess, the bullet points 5 and 6 do not fit Afrigen either. So, we conclude: Afrigen is not open-source. But it has important and far-reaching characteristics of scientific openness.

Is Corbevax open-source?

In contrast to Afrigen’s vaccine, the CVD has a vaccine design out there, and it is publicly accessible via academic publications. While Peter Hotez and Elena Maria Botazzi told us in an interview that, apparently, the vaccine design can be duplicated from the published resources, it is not recommended due to the complexity of technologies in use. The CVD rather strives for close-knit tech-transfers with interested parties that can license the patent-free Corbevax vaccine, which has so far led to successful knowledge-sharing, production, and dissemination of the vaccine in several low- and middle income countries. Concerning the bullet points 4, 5, and 6 the CVD resembles Afrigen. Still, Corbevax is closer to being open-source than Afrigen’s vaccine. It is patent-free, with involved actors very dedicated to collaborating with interested parties. But it is not collaborative in a strict sense, and it does not facilitate any modifications of their vaccine design, though CVD does not actively prevent it. Accordingly, we don’t see Corbevax as strictly open source, either.

Is there a “real” open-source vaccine?

To our knowledge, there is particularly one organization that embraces the characteristics for a genuine open-source vaccine, the Rapid Deployment Vaccine Collaborative (RaDVaC). Since the beginning of the pandemic, RaDVaC has openly shared vaccine designs publicly in White Papers, licensed all knowledge under a creative commons license, and has been supportive regarding modification and rapid prototyping of collaborators all over the globe. They encourage individuals to partake in the endeavor of vaccine research at any point, for instance by fostering collaborations through a researchers’ map. Also, RaDVaC engages in public discussion through organizing a conference or a public Discord channel, but presumably not all emails are transparent. Taken together, RaDVaC comes quite close to what one could ideally expect from an open-source vaccine. However, sharing their vaccine’s recipe and encouraging others to mix and administer the nasal vaccine themselves radically breaks with pharmaceutical and medical conventions and has also spurred criticism.

Are there open-source vaccines?

In the world of software, modifying and rapidly prototyping open-source codes is central. This is not easily accomplished in pharmaceuticals. Sharing the “code” of a vaccine, publicly disclosing its recipe to modify the vaccine design, and tinkering with it, is criticized and can be evaluated as an offense. There is no chance to get a vaccine approved that is constantly modified. Thus, under current regulatory practice, it is at least very difficult, if not impossible, to fundamentally open source a vaccine. However, there are organizations trying. If you know of any further organization, initiative, or project that embraces open-source principles and practices on vaccine R&D, please get in touch or share infos in a comment.