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Coronavirus: the six questions you still ask yourself about the vaccine

  • What do you need to know about the virus to be able to make a vaccine?

To develop a vaccine against a viral disease, it is necessary to know intimately the virus which causes it, since the vaccine will be made from certain parts of the virus which will make our immune system react. This response will be memorized and will allow our organism a quick and efficient response during the “real” encounter to come with the virus.

It is therefore necessary: ​​to isolate it and to succeed in obtaining a sufficient quantity in the laboratory to study it; know its constituents (genes, proteins, the elements it needs to multiply inside human cells) in order to understand how it infects human cells. This knowledge will then make it possible to explore strategies for blocking its entry into the cell or blocking its multiplication once it has entered the cell.

  • How long does it take to produce a vaccine in large quantities?

The 18 to 24 month deadline announced is a real performance and requires that clinical trials, investments in production capacity and securing the supply of raw materials be carried out simultaneously so that production can begin as soon as the end of these tests, or even before. The date of availability of a vaccine will vary depending on the successes or failures of the development of the various candidate vaccines in the running, of the existing processes and of the construction, in parallel with the testing phases, of the chains necessary for the production of the vaccine.

Under normal circumstances, the registration and validation of a production site meeting Good Manufacturing Practices (GMP or GMP in American) can take up to three years. The acceleration of the production of the new Covid-19 vaccine therefore depends closely on the technological process chosen, the knowledge already existing for the future production of this vaccine and the possibilities of accelerating the regulatory procedures.

  • How are production and distribution monitored?

Quality control takes up 70% of vaccine production time. The manufacturers carry out at each stage of manufacture many controls relating to the quality, the effectiveness and the safety of the product (presence of the active substance in the expected quantities, purity, verification of the elimination of the products intervening in the manufacture, etc. .).

The conditions for placing vaccines on the market are reinforced compared to those for other drugs via a batch release procedure by the ANSM. This procedure is imposed by European regulations which require 100% quality control of vaccine batches before they are placed on the European market by the official laboratory in charge of it. The future Covid-19 vaccine will therefore be subject to all of these checks.

The controls are carried out routinely on samples of finished products, but also on products in the course of manufacture, with four elements tested: its identity, ie the suitability of the finished product with what is expected; its activity in the laboratory or in animals; the stability of its components; the absence of contamination by foreign microorganisms.

  • Where will the vaccines be produced?

Europe is the leader in vaccine production, with 27 production sites in 11 countries of the European Union. It produces 1.7 billion doses of vaccines each year, or 76% of global production.

The choice of production plants for the Covid-19 vaccine will depend on the type of vaccine to be produced and the technological process used. The pressure is extremely strong on vaccine producers to anticipate the production of vaccines against Covid-19, without waiting for the results of ongoing research, while ensuring the normal production of other vaccines. The Bill and Melinda Gates Foundation has announced that it is pledging to build factories for seven Covid vaccines.

However, the location of an industrial site in a given geographical area does not mean that the production of this site will be entirely dedicated to this area: production sites can produce to supply all continents, the various production phases of a vaccine can be produced at several different sites (antigen production, filling and lyophilization, packaging). The vaccines that would ultimately be distributed in France could therefore be produced on several continents.

  • How will the Covid-19 vaccines be distributed?

Given the urgency of the situation, whether in high-income countries or countries with lower resources, it will be necessary to work very closely between governments, supranational organizations (European Union) and international organizations (WHO among others). ).

Pharmaceutical companies are particularly committed to ensuring that the vaccines developed are made available to everyone, everywhere in the world, on condition of course that they successfully pass the various stages of development.

  • Will the vaccine contain adjuvants?

Not necessarily, since live vaccines (also including vector vaccines) are sufficiently immunogenic, sometimes with only one dose, and do not require an adjuvant while most inactivated vaccines require the addition of an adjuvant.

Generally, the advantage of an adjuvant, which increases the immune response, is to: reduce the amount of antigen per dose: this is particularly advantageous in the event of a pandemic where the manufacture of a sufficient number of doses of vaccine may be a factor limiting vaccination, reduce the number of doses necessary to ensure good immunization, strengthen the immune response in people with “weak responders” or with a certain degree of immunosuppression (especially the elderly). As the development of SARS-CoV-2 vaccines is still at a very early stage, it is still too early to identify those requiring adjuvants and the type of adjuvant to use.

Questions / answers taken from a document produced by Leem (The drug companies) published on Friday July 24, 2020.

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