Spain could test the COVID-19 vaccine in humans in early 2021.
Some of the Spanish prototypes for the COVID-19 vaccine are now involved in animal experiments and, if the results are positive, several groups may ask the Spanish Medicines Agency in December for permission to start clinical trials on humans.
Once this permission is obtained, which could take weeks or months, the first phase of these trials with healthy volunteers would begin.
A laboratory at the Margarita Salas Centre for Biological Research (of the Higher Council for Scientific Research -CSIC-) is now testing mice to see if the necessary immune response occurs, and the plan is to start experiments with humanized mice in September.
The latter, in a laboratory with special security, will be inoculated with the virus and it will be checked whether, with the vaccine prototype, they resist it: if the viral load and lung damage decrease.
In the best scenario, and if the results of these phases in animals are positive, the Spanish Agency of Medicines and Health Products (AEMPS) may at the end of the year ask for permits to start clinical trials.
This permission is not given immediately but the project has to go through an examination by the AEMPS.
Once achieved, it is the head centre that, together with hospitals and/or pharmaceuticals, organizes the clinical trial.
Clinical trials have three phases, plus a fourth review applicable only when the drug or vaccine has already been approved by regulatory agencies and is on the market. Each of the stages of an essay is designed to answer some questions.
In phase 1, safety is tested and it is the first time that the substance is administered to humans – the CSIC has already received requests from volunteers to participate in this phase.
This stage is carried out with less than a hundred healthy volunteers, and its main objective is to establish whether the substance is safe and does not cause harm to people, but it also serves to determine the best way to administer it and what would be the appropriate dose in order not to harm patients.
Once it has been verified that the vaccine candidate is safe, its efficacy must be determined. In phase two a greater number of people participate, and in the third this number reaches thousands.
Here it is checked whether immunization truly protects the population against exposure to the coronavirus. If the results are positive, drug regulatory agencies can grant authorization and sale of the vaccine.
The procedure has already been tested in a vaccine for canine leishmaniasis that is in the last phase – request to the European Medicines Agency for a manufacturing and marketing permit.
Its development, according to those responsible, has an additional advantage: the industrial scaling process of the vaccine candidate has already been carried out previously, which would significantly advance the industrial manufacturing phase, human tests and subsequent production, provided that the results of the tests are positive; the vaccine, in any case, would not be ready for at least a year.
In Spain, with public funding, there are 12 projects investigating a vaccine and five already have a candidate. Another of the most advanced and which also begins tests on humanized mice in September, is that of Mariano Esteban with Juan García Arriaza at the National Center for Biotechnology (CNB-CSIC).
Esteban is developing a vaccine based on a modification of the virus used in smallpox eradication in the 1970s.
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