The good news continues in the fight against the coronavirus after the recent announcements by Pfizer and Moderna, and this time it falls directly to Spain. The Ministry of Health has announced in a statement that The Spanish Agency for Medicines and Health Products (Aemps) has authorized the clinical trial in phase 3 of the vaccine of the Janssen company, belonging to the multinational Johnson & Johnson.
With this announcement, it is about the first phase 3 clinical trial to be carried out in Spain regarding a vaccine against the COVID-19 pandemic. In it, the efficacy and safety of a vaccine that will also be tested with some 30,000 volunteers from eight other countries (Belgium, Colombia, France, Germany, the Philippines, South Africa, the United Kingdom and the United States).
According to the statement from the Ministry of Health, it is defined as a pivotal, multinational trial with a double-blind design. In other words, The vaccine or a masked placebo will be administered so that it is not identified with the naked eye and thus the evaluation can be carried out more effectively.
What will the rehearsal be like?
In order to carry it out in Spain you will need nine hospitals, which will begin recruit volunteers, who must meet various requirements and criteria indicated in the protocol. First, those who do not have comorbid illnesses associated with an increased risk of severe coronavirus will be vaccinated..
Later, it would be the turn of those who do have comorbidities associated with an increased risk of severity, once an evaluation by an independent committee has occurred before surveillance of security data.
What is known of patient profile is that 20% will be under 40 years old and 30% will be over 60 years old. Equally, everyone will be monitored and all cases of coronavirus that occur will be identified.
You have to wait until the end of the trial to draw conclusions
It is important to conduct the entire process with caution and care, so that, although preliminary analyzes can already be carried out with intermediate data that are collected, we will have to wait until the end of the clinical trial to analyze all the data extracted and announce the final conclusions.
This essay is part of the steps to follow before marketing a vaccine known as Ad26.COV2.S, which is based on a non-replicative recombinant adenovirus. It is characterized by search for an immune system response to coronavirus proteins, that is, the S protein.
“Only after analysis of the data by the competent regulatory authorities, and a favorable evaluation of the benefit-risk balance, would the commercialization be authorized. in European territory ”, is stated in the Health statement.