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 …read more
Source:: World Today News