By now, 4.9% of European citizens have been inoculated with two doses of vaccine against Covid-19. The percentage of Spain is somewhat higher than the European average, specifically 5.4%.
In hungary 6% of the population has already received a complete vaccination. Also in Hungary the percentage of vaccinated with a single dose reaches 19.7%, almost double that in Spain (10.8%).
However, these numbers are still too low if we compare them with the US, where he percentage of complete vaccination is 13.7% of the total population. Or with the United Kingdom, where 54.4% of the population has already received the first dose of the vaccine.
Which are the reasons for these differences in figures? 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. That 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 logistics support companies for production in other countries.
In Spain, for example, they are four that give this support in the production of the antigen: Rovi, which manufactures the Moderna 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).
Which can block or halt 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 nucleic acid, and that are incorporated into the production chain. That means the nanolipids are essential raw materials, with the United States and the United Kingdom as the main producers.
Any access problem to these components would be a bottleneck since there are no producers in Europe who 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 consider. After vaccines are produced, they must be packaged, labeled, and stored for distribution. At that point, you need large shipments of glass vials – mostly produced in the US – and rubber stoppers – mainly made in Asia-. 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 depends on China to provide the plastics from which they are made.
Taking into account that 16 billion doses need to be produced worldwide, have anticipated the demand for antigens, vials, syringes, etc. needed to vaccinate is complicated.
The importance of a plan B
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 that 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 rhythm of vaccination.
Currently Spain and Europe only have the Pfizer, Moderna and AstraZeneca vaccines. However, there are countries that have purchased other vaccines already available in other markets.
This is the case of Hungary, which also handle the Russian vaccine Sputnik V –With two non-replicative adenoviruses–, and the Chinese vaccine from the Sinopharm company, BBIBP-CorV [https://covid19.trackvaccines.org/vaccines/5/]- with inactivated coravirus, approved for use in 27 countries. This explains that this European country goes faster than the average of the rest of Europe.
Bearing in mind that the more vaccines are available, the better it will be possible to tackle the small problems that affect the rate of vaccination, It is urgent that in Europe it is allowed to be able 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 these raw materials so necessary for the production and packaging of these and other vaccines, and not depend on third countries.
Second, it would be useful to help or encourage the establishment of more biotech companies that support in the production, packaging and logistics to the pharmaceutical companies that produce vaccines.
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, Biofabric. This is the company that will produce vaccines for SARS-CoV-2 from the Higher Council for Scientific Research, of the groups of Mariano Esteban, with an Ankara virus that includes the SARS-CoV-2 protein S, and Vicente Larraga, with a DNA vaccine that encodes protein S. Both are very promising, awaiting approval by the EMA to start the first clinical trials.
Seems more investment in biopharmaceuticals is essential that they dedicate themselves 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.
* This article was originally published on The Conversation.
** Carmen Álvarez Domínguez is a biochemist and molecular biologist, immunologist, expert in vaccines and professor of research in Sanitary Processes at the Faculty of Education, UNIR – International University of La Rioja.