The Ministry of Health has announced that the Spanish Agency for Medicines and Health Products (Aemps) has authorized the phase 3 clinical trial in Spain of the Janssen covid-19 vaccine, owned by the American multinational Johnson & Johnson. It is the first phase 3 trial for a coronavirus vaccine authorized in Spain.
Health explains in a press release that it is a double-blind design trial, that is, “the vaccine or a placebo is administered masked in such a way as to prevent its identification with the naked eye.” This is how the safety and efficacy of the vaccine, which is administered in two doses, is studied. This clinical trial requires the participation of 30,000 volunteers, who will be recruited in Spain (2,000) and eight other countries (Belgium, Colombia, France, Germany, the Philippines, South Africa, the United Kingdom and the United States). Nine Spanish hospitals will begin “as soon as possible” the search for volunteers. The national coordinator will be José Ramón Arribas, head of Infectious Diseases at Hospital La Paz, as accredited the registry of tests of the Ministry of Health (Reec).
Johnson & Johnson Vaccine is based on a cold adenovirus, modified with genetic information from the new coronavirus to try to safely induce specific defenses in vaccinated people. “This is our development, which we also use in the Ebola vaccine that was approved a couple of months ago and in one for HIV that is also in phase 3,” said Antonio Fernández, from the research team of the drug from Janssen, the pharmaceutical brand of Johnson & Johnson. In this case, he explained, the virus is non-replicating, so it only acts as a transporter for the genetic material of the coronavirus to generate the immune response and does not itself cause an infection. Specifically, the adenovirus will be “loaded” with a sequence of the spike protein s (the part of SARS-Cov-2 that binds to the cells of its victim) chosen after testing 12 sequences first in culture and then in macaques and modified to give it more stability, the laboratory researcher explained.
Arribas affirms that in La Paz they already know the medicine because they also participated in phase 2 of the investigation and that more will be added to the initial 30,000 volunteers, up to 70,000, to cover all age ranges and health conditions of the population. The trial will be double-blind, that is, one group will receive a placebo (something that looks like the pro vaccine with no effect) and neither the patient nor the doctor will know what each is taking until the end of the trial.
The development of phase 3 of the trial will consist of two steps. First, “participants without concomitant diseases that are associated with an increased risk of progression to severe COVID-19 will be initially vaccinated.” An independent committee will assess the safety of that stage. Once overcome, “it would eventually include participants with concomitant diseases that are associated with a greater risk of progression to severe covid-19.”
All experimental vaccines, After the first tests on animals, they must pass three phases of human trials. The first stage, with a few dozen healthy volunteers, serves to rule out serious effects. In phase 2, with hundreds of people, the aim is to confirm safety, analyze the induced immune response and adjust the dose. In phase 3, the prototype must demonstrate that it is effective and safe in tests with tens of thousands of participants, which is the stage of the Johnson & Johnson vaccine.
The European Commission maintains a preliminary agreement to purchase 200 million doses of Janssen’s vaccine, among other agreements with other pharmaceutical companies. In the world there are at least 234 vaccine projects underway.
“These clinical trials are part of the requirements that all investigational vaccines must carry out to demonstrate their quality, safety and efficacy. Only after they have been evaluated and if they comply with regulatory standards, will they be authorized for commercialization “, says the Ministry of Health in its press release. “The beginning of clinical trials is another milestone on this path that should end with the eventual authorization and availability of safe and effective vaccines to the public,” he adds.
This news comes after other drug companies announce that their vaccines work in intermediate trials. In just one week, three vaccines against covid-19 point to high levels of efficacy against the virus: 90%, the Pfizer vaccine; of 92% the Russian Sputnik V; Y the last, that of Moderna, more than 94% effective. But the information comes through the press releases of the pharmaceutical companies, not through the official channel, which is the publication of the clinical trial in a scientific journal of impact.
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