Expansion of supply volumes for Covid 19 vaccines
In less than a year, pharmaceutical companies have not only invented and tested the first COVID-19 vaccines, but have also set up large-scale production for them. That's why they can deliver vaccine at all right now, even if only in smaller quantities. Now they are discussing how to speed up the expansion of delivery volumes.
Deliveries will soon be expanded. vfa president Han Steutel says: "We will have significantly more vaccinations in January, because more and more of the ordered quantities will be delivered. This only works because the manufacturers have pre-produced. Every other manufacturer that gets approval will also be quick to market with pre-produced batches." And the next manufacturer could indeed join by February if its vaccine receives approval. The European Medicines Agency ( EMA ) is due to make a decision on January 29th, 2021.
To ensure as many vaccine doses as possible, the companies with the most advanced COVID-19 vaccines have already been expanding not only their own production capacity for months, but also establishing more and more collaborations with other companies. After converting the facilities and training the personnel, these companies then supply components for the vaccine, for example, or take over certain manufacturing steps in parallel to the original manufacturers, or produce the vaccine in question completely independently under license. If the original companies identify other potential partners for such collaborations, they can expand even further in this area.
Collaborations, not compulsory licenses, are the path to rapid expansion
However, the idea of using patent revocations and compulsory licences to commission other pharmaceutical companies with the production of vaccines does not promise a rapid expansion of production capacities. Vaccine production is one of the most demanding tasks in drug production. Every detail counts.
Vaccine production always requires intensive technical preparation. Nothing can be done on short notice.»
Only with the help of the original manufacturer can another company participate in production after a reasonably short period of preparation. That is why collaborations are the logical way to quickly expand production volumes.
Production methods for COVID-19 vaccines: demanding and varied
The production method for the different types of vaccines already licensed or in development against Covid-19 differs significantly from each other. In most cases, it also differs significantly from the production method used for the usual vaccines against other diseases recommended in Germany, which are produced directly from killed or attenuated pathogens.
For example, some of the COVID-19 vaccines are based on biotechnologically manufactured spike protein from the SARS-CoV-2 virus. Physicians call them subunit vaccines. In one case, their production uses a culture of insect cells in nutrient medium that have been genetically engineered to produce the protein in question. This protein must then be purified from all remnants of the insect cells and the nutrient medium. Only then can it be processed together with an emulsion of adjuvants to produce the finished vaccine. The adjuvants serve to strengthen the immune response in the vaccinated persons. The finished vaccine is then filled into sterile glass vials.
Vector virus vaccines are produced in a completely different way. They require large cell cultures with mammalian cells. Biotechnological methods are used to insert several different pieces of DNA with specific genes into the cells, whereupon they form viruses ‒ not coronaviruses, but harmless vector viruses that cannot make people ill. The cells also provide the viruses they produce with the genetic blueprint for the spike protein. The vector viruses are finally "harvested" from the cell culture. After they have been thoroughly but gently purified, they can be filled into glass vials in a liquid suitable for vaccination, stored in a cool place and transported.
The production of messenger RNA (mRNA) vaccines is even more different. In the first step, bacteria, which have been genetically engineered with small ring-shaped pieces of DNA (plasmids), are reared in large bioreactors. The DNA-rings multiply with the bacteria. When the bacteria are then killed, they release the plasmids. These are necessary as templates for the production of the actual mRNA which is carried out in the next step. In a further step, the mRNA is then enclosed in a liquid in submicroscopic vesicles consisting of nature-identical and artificial lipid-like molecules; these vesicles, known as lipid nanoparticles, must neither be too small nor too large. The finished solution with the lipid nanoparticles is then filled into glass vessels.