Researchers and pharmaceutical companies worldwide are focused on finding an effective and safe vaccine against COVID-19, with some leading projects, such as that of the American company Moderna or that of the University of Oxford (United Kingdom).
Finding it will mean ending a pandemic that has collapsed the world. However, there is a greater challenge: being able to have enough doses for all countries to achieve the long-awaited immunity . This would require between 12 and 15 billion doses , because, although the world population is around 7.7 billion people, some of the vaccines under investigation require two doses to be effective. And, in addition, these quantities would have to be manufactured in record time.
The problem is that global production capacity is low . This is stated by Thomas Cueni, general director of IFPMA, the association that brings together the main pharmaceutical companies from around the world. Cueni explains that, today, there are not enough vaccine or packaging factories to obtain those billions of doses. “The challenges should not be underestimated,” says Cueni. The priority objective, he points out, is to analyze how to expand production. “As Bill Gates said, if we can only produce 300 million doses in each plant, we will have problems.” Currently, says the expert, “the five or six large manufacturers in total produce less than half that volume in a year.” And that, taking into account that they should stop producing immunizations necessary for other types of diseases .
This reality requires establishing close collaboration between governments and pharmaceutical companies, as well as the promotion of the World Health Organization and philanthropic aid. Precisely, the Bill & Melinda Gates Foundation has already announced that it is willing to donate billions of euros to build seven vaccine factories . These would dispatch, as estimated by IFPMA, 3 billion doses, an amount still insufficient to provide global coverage. Adding to the challenge is also the urgency of having sufficient glass vials. A solution, according to Cueni, could be that a single container contains five or ten doses, instead of the conventional single-dose bottles. In addition, low-income countries may experience storage problems, as these drugs must be stored at temperatures of -80 ° C.
Such is the concern that several companies are already manufacturing thousands of doses before knowing if clinical trials will give the expected results. This is what is called risk production . One such company is Johnson & Johnson , which has committed to supplying more than 1 billion doses of its investigational vaccine worldwide throughout 2021; provided, of course, that it manages to show its effectiveness in the tests.
According to Martín Sellés, president of Farmaindustria, the employers’ association of the main pharmaceutical companies based in Spain, “it represents a great risk, but it is the only way to be able to commit the greatest challenge that we will face once we have effective vaccines: having production capacity on a large scale to produce several billion doses in a short time ”.
The truth is that access to the vaccine is an issue that worries and occupies all countries. The European Commission has presented a strategy based on offering financing to those projects with the highest probability of success. In return, the countries of the European Union will have preferential access once it is available.
In addition, it will be necessary to establish specific prioritization plans to administer the vaccine to the population . In fact, the Spanish Ministry of Health proposes to do it based on the vulnerability and exposure of individuals to the disease , and according to the characteristics of the vaccines. This is stated in the draft of the Early Response Plan in a pandemic control scenario for covid-19 drawn up by the Government. This document highlights that the first doses on the market for future immunization would be administered taking into account the available data on the efficacy and safety of each drug, as well as the epidemiological features of COVID-19. Subsequently, the criteria based on the aforementioned vulnerability and personal exposure to the infection would be followed.
The future supply of doses to immunize the world population against the SARS-CoV-2 virus depends on the production and storage capacity of the therapeutic compound, but also on the large-scale manufacture of vials .
The Spanish case
Today in our country there are no human vaccine production plants, which makes it even more difficult for our country to have a sufficient supply. The Ministry of Health is aware of this handicap, and for this reason it is already working to adapt the veterinary immunization factories . In fact, the minister of the field, Salvador Illa, assured during his appearance in the Health Commission of the Congress of Deputies that already These manufacturers have been contacted to assess their production capacity and they will be advised “to comply with the requirements and obtain authorization to manufacture for human use.” Health has put them in communication with Spanish researchers working on the vaccine.
In addition, Spain will be part of the production process of the preparation developed by Moderna. The US pharmaceutical company has announced that Rovi Pharma’s Madrid plant will provide vial filling and finishing capacity to supply markets outside the United States.
