What are the reasons for these differences in the numbers? To be able to answer, one must take into account what is needed to produce, manufacture, package, store and distribute a vaccine.
The first thing is to produce the “biological” that is, the antigen. This requires putting qualified pharmaceutical companies to work in the production of medicines with quality standards and production criteria under sterile conditions. –What is known in scientific jargon as GMP conditions–. This requirement involves both the original pharmaceutical companies that have created the antigen and the logistical support companies for production in other countries.
In Spain, for example, there are four that provide this support in the production of the antigen: Rovi, which manufactures Moderna’s vaccine and is located in San Sebastián de los Reyes (Madrid); Insud Pharma, which manufactures AstraZeneca vials in Azuqueca de Henares (Guadalajara); Reig Jofre, who will produce the Janssen vaccine in Barcelona (Catalonia); and Biofabri (Zendal Group), which leads Novavax’s industrial antigen production in O Porriño (Galicia).
What can block or paralyze production? Obviously it depends on the type of vaccine, but those that are available have many points in common.
Without going any further, to manufacture the mRNA vaccines from Pfizer and Moderna, the nanolipids that coat and protect the nucleic acid are needed, and that are incorporated into the production chain. That means that nanolipids are critical raw materials, with the US and UK as the main producers. Any problem of access to these components would suppose a neck of bottle since there are no producers in Europe that could give support. AstraZeneca’s raw materials are the adenoviruses themselves and here the raw material itself may not be a problem, but other production problems such as antigen scaling or purification can cause unexpected problems that cause delays in distribution and therefore both in vaccination.
There is another sticking point to keep in mind. After vaccines are produced, they must be packaged, labeled, and stored for distribution. At that point, large shipments of glass vials – mostly produced in the US – and rubber stoppers – made mostly in Asia – are needed. The shortage of raw materials for the packaging phase would also produce a plug that would affect the distribution of the vaccines. In fact, it has already happened with the AstraZeneca vaccines.
Nor should we forget that syringes are essential for vaccination. In Spain, the Becton Dickinson company is the most important producer. And it depends on China providing it with the plastics from which they are made.
Bearing in mind that 16 billion doses need to be produced worldwide, anticipating the demand for antigens, vials, syringes, etc. needed to vaccinate is complicated.
The importance of a plan B (and even a plan C)
To all this is added another important deficiency: the lack of a General Vaccination Plan that includes a plan A, a plan B and even a plan C. So if at any given time a type of vaccine is not available, for example because an unforeseen adverse effect is questioned, there are alternative vaccines so as not to paralyze the rate of vaccination.
Currently Spain and Europe only have the Pfizer, Moderna and AstraZeneca vaccines. However, there are countries that have bought other vaccines already available in other markets.
This is the case of Hungary, which also handles the Russian Sputnik V vaccine –with two non-replicative adenoviruses–, and the Chinese vaccine from the Sinopharm company, BBIBP-CorV with inactivated coravirus, approved for use in 27 countries. This explains why this European country goes faster than the average of the rest of Europe.
Taking into account that the more vaccines available, the better it will be possible to tackle the small problems that affect the rate of vaccination, it is urgent that Europe be allowed to use these two vaccines already available in other markets. In addition to another couple that are just around the corner: Janssen’s vaccine also based on a non-replicative adenovirus that only needs one dose, already approved by the European Medicines Agency (EMA); and Novavax, protein-based but with easier logistics as it does not need refrigeration.
Investment in industries and R&D
From all the above we can draw three conclusions. The first of these is that European countries They must invest in industries that handle and generate those raw materials so necessary for the production and packaging of these and other vaccines., and not depend on third countries.
Second, it would be advisable to help or encourage the establishment of more biotechnology companies that support pharmaceutical companies that produce vaccines in the production, packaging and logistics.
The third conclusion, no less important, is that more investment in R & D & i is required to have strong research groups that can produce European vaccines.
Finally, in Spain only one biopharmaceutical company manufactures, researches and develops vaccines for human use, Biofabri. This is the company that will produce the vaccines for SARS-CoV-2 of the Higher Council for Scientific Research, of Mariano Esteban’s groups, with an Ankara virus that includes the S protein of SARS-CoV-2, and Vicente Larraga, with a DNA vaccine that encodes the protein S. Both are very promising and are awaiting approval by the EMA to start the first clinical trials.
It seems essential that there be more investment in biopharmaceuticals that are dedicated to the research, development and manufacture of vaccines for human use and more investment in R + D + i in vaccines for different public and private research organizations. These improvements will make us have more capacity and speed to respond to this and future pandemics.