How to secure the supply of Covid vaccines for Europe? Part 2.

While countries like Israel and the USA have come a long way with vaccination, Europe is still far behind the vaccination schedule. Why did this situation arise, and what can be done to make Europe's vaccination program more efficient? Vaccine technology specialist Klaus Hermansen explains.

Vaccinating Europe – a race against time

At the end of April 2021, 59% of the Israeli population and 30% of the US population are fully vaccinated. In comparison, most European countries only have approx. 10% of their populations vaccinated, and the ambition to have 'everyone' in Europe fully vaccinated only by the end of August 2021.

Although vaccines from different manufacturers are available, supply has proved not to be sufficient. And an additional challenge is the rare but severe side effects observed with certain vaccines. Different European countries assess the risks of such side effects differently, and national recommendations vary accordingly. When a certain vaccine is approved in one country but is restricted or stopped in another people are confused and may lose their trust in the vaccination strategy. Eventually, some may even mistrust vaccines as such. For example, the AstraZeneca vaccine is still recommended to use by EMEA, but Denmark has temporarily stopped the use, and countries like UK, Sweden, Germany, and Norway have introduced limitations based on age, for the use.

Could this situation of insufficient vaccine supply and hesitant public attitude be avoided by a more proactive vaccination strategy?

Europe vs the US – a comparison

Manufacturing capacity and partnering have been either missing or vastly limited in Europe, whereas in the US, vaccine companies have been significantly supported by the government (BARDA) and organizations such as Bill & Melinda Gates Foundation.

An example of this is Catalent, which expanded its partnership with Johnson & Johnson to fill and pack a larger amount of vaccine in their facility in Indiana. It is first now in April 2021, that Johnson & Johnson will start using the Catalent facility in Italy to support the European demand. The US government and Bill & Melinda Gates Foundation have spent more than 5 billion USD to support the country’s vaccine program.

To ramp up production of the AstraZeneca vaccine in Europe, a facility in Leiden, Netherlands, has just been approved – but probably too late for a game-changer in Europe.

BioNTech’s large manufacturing facility in Marburg, Germany has just been approved and will now be able to produce approximately 1 billion doses a year – excellent, but not fast enough for the struggling population in Europe.

Additionally, Lonza, Switzerland, has just been approved for manufacturing the Moderna vaccine.

When comparing the US and Europe, governmental support obviously makes a big difference.

The way forward for Europe

By learning from history and the current global Covid vaccine situation, I believe there are some key factors for vaccination program success.

1. Support

Vaccine technology is very complex, with many different manufacturing options for the manufacturing process. Further, it is not always possible to predict what vaccine will fight the next pandemic. Thus, the financial support of private vaccine companies from governments or organizations may prove vital for the success of an extensive vaccination program.

2. Private vaccine companies

Today we have three main technologies for the active component (API) for Covid-19 vaccines:

• The viral vector technology that is used for the Adenovirus-based vaccines such as the Johnson & Johnson vaccine, the AstraZeneca vaccine, and the Sputnik vaccine.
• The mRNA technology that is used by BioNTech/Pfizer and Moderna.
• More traditional vaccine technology based on inactivated Covid-19 virus (like most vaccines developed in China).

To keep these technologies alive on a country level would require unrealistic resources. It would be difficult to establish, and eventually, it would fail over time as it did for the preparedness plans for pandemic flu.

Accordingly, let the private vaccine companies develop and produce at least the active component in the vaccines – they are outstanding in that.

3. Co-operation and alliances

Instead of each manufacturer running its own complete process, the three main steps in the manufacturing process could be produced in an alliance of several companies. A co-operation where the strength of each company is optimally used will make it possible to produce much more vaccine.

But, investments in manufacturing capacity are also required, and these investments could be financed by raising vaccine prices in general. If also national organizations could step in and financially support the manufacturing companies, it could make a huge difference for the scalability.

A possible European alliance

Here is an example of such an alliance where individual companies could contribute with their strengths respectively.

1st step – mRNA API (active component) could be produced by companies like Rentschler Biopharma in Germany and others. Novartis could potentially produce DNA molecules that support this production step.          

2nd step – mRNA will be enclosed into nano-lipid capsules. These lipids could potentially be delivered by Merck and the German company Evotec Industries. The enclosing technology could come from Polymun Scientific Immunbiologische Forschung in Austria, the Canadian Acuitas Therapeutics, and the German Dermapharm Holding. Not an easy process and difficult to scale up.

3rd step – For formulation and filling, there are more options available. Alliances that I could see prosper are between the French company Delpharm, the German company Siegfried, the German company Baxter Oncology, and other companies like Novartis, Dermapharm, Sanofi, and GSK.

The main bottleneck is probably the supply of lipid-nanoparticles since there are only a few manufacturers that can do this particular process.

Collaboration – the ultimate key to success

For a successful international vaccination program, all stakeholders at every level should collaborate. Local governments should collaborate with each other and also support the vaccine industry. Vaccine manufacturers should collaborate to optimize production volume and quality. Regions, authorities, and service companies should collaborate to facilitate distribution. And finally, even the individuals who are to be vaccinated must collaborate by not causing delays or waste of vaccines simply by not showing up.