BioNTech reveals a solution to Vaccine accessibility all over the world

BioNTech is most recently known for its mRNA COVID-19 vaccine which was approved in December 2020. This great accomplishment, however, was challenged by the obstacle of limited global manufacturing. Currently, vaccines are only being manufactured in the United States, United Kingdom, India, Germany, Belgium, Russia and China. Developing nations in Africa and South America face monumental challenges in procurement, allocation, distribution and uptake of vaccines.

Vaccines need to be distributed and administered to entire populations—with considerations for individual risk level, remote geography, cultural and socio-economic factors. This requires logistical and trained personnel support that can be hard to come by for resource-poor nations. Several vaccines also require ultra-cold temperatures for storage and transport and therefore the need for specialized equipment and reliable power supply which may also not be readily available. Lastly, attention will need to be paid to ensuring adequate uptake of vaccines since vaccine hesitancy has already been reported for COVID vaccines. Ugur Sahin, BioNTech founder saw the importance of making achievements available everywhere in the world and took the initiative to come up with a solution.

The manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer. Each module is built of six ISO sized containers with the dimensions 2.6m x 2.4m x 12m. This allows for mRNA manufacturing and formulation, while fill-and-finish will be taken over by local partners, all in bulk. Currently, the models include air purifiers, electricity and IT infrastructure to name a few. Each BioNTainer is a clean room which BioNTech equips with state-of-the-art manufacturing solutions. Together, two modules require 800 sqm of space and offer an estimated initial capacity of up to 50 million doses of the Pfizer-BioNTech COVID-19 vaccine each year.

Furthermore, its construction allows it to be transported through various means as cargo (such as planes, ships and trains) to all continents. These structures are also replicable with a standardized concept. These all address and offer solutions to some of the aforementioned challenges developing countries face regarding vaccine production, mainly with storage and transport. In addition to manufacturing COVID-19 vaccines, the manufacturing solution is suited to manufacture any mRNA-based vaccines and therapies. This includes potential future vaccines against infectious diseases such as malaria and tuberculosis, both of which plague the populations of some of these developing countries. At the moment, BioNTech is working with the World Health Organization, Africa Centres of Disease Control and Prevention (Africa CDC), the Africa Medicine agency and the European Commission with the goal of establishing an end-to-end production network of mRNA-based vaccines in Africa starting with Rwanda, Senegal and possibly South Africa.

This is a tremendous step forward in increasing accessibility of vaccines and in turn increasing mass vaccination of the global population thus curbing the spread and offering hope toward ending the global pandemic caused by SARS-CoV2.

Others have also tried expanding global accessibility of vaccines before this with different concepts however, BioNTech is the first one to have this particular manufacturing solution. One interesting example is the following: In 2021, a chemical engineer at the Georgia Institute of Technology, Saad Bhamla co-developed the ePatch. This device is meant to make vaccination accessible all over the globe by reducing the overall costs which are mainly due to mRNA vaccines having to be stored at extremely low temperatures prior to injection. The ePatch was made based off electroporation. In theory, applying electroporation alongside genetic-material vaccines could improve both effectiveness and accessibility. For mRNA vaccines, genetic material might be able to enter cells without lipid nanoparticles; this means the vaccines could possibly be stored at room temperature. For DNA vaccines, which are already stable at higher temperatures, researchers think electroporation would help generate a stronger immune response—and perhaps make DNA vaccines more widely adopted. However, so far, this technology has only been tried with DNA vaccines in clinical trials—and even this use is still in its early stages. It has not yet led to a licensed vaccine.

Due to this we can foresee that BioNTech’s solution will most probably be the most successful one for the time being since it solves the manufacturing dilemma outright instead of altering the delivery of the vaccine which despite being a revolutionary concept, requires more research and involves a lot more obstacles.

For the life science start-up ecosystem BioNTech’s initiative shows that we not only need innovation in developing new therapies, but we also need to follow new paths in operations and production to win the fight against global disease like SARS-CoV2.

Here you can find out more about this topic:

Ugur Sahin’s Linkedin announcement:

BioNTainer Press Conference:

(Author: Mwesigye, Siima-Stacy)