Spain will begin its first clinical trial of a coronavirus vaccine. The Spanish Agency for Medicines and Health Products (AEMPS) has authorized the clinical trial in Spain of the Janssen vaccine, thus becoming the first trial of this type for a coronavirus vaccine authorized in the country.
As pointed out by Health, this pivotal, multinational trial, with a double-blind design, in which the vaccine or a masked placebo is administered, will study the safety and efficacy of a two-dose regimen of this vaccine with a total of 30,000 volunteers from nine countries, including Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States.
Specifically, in Spain this trial will be carried out in nine hospitals that will start, as soon as possible, the recruitment of volunteers who meet the inclusion criteria specified in their protocol.
The study will initially vaccinate participants without diseases associated with an increased risk of progression to a severe prognosis from coronavirus. Thus, and after evaluation by an independent surveillance committee of the safety data of these participants, it would eventually include participants with concomitant diseases that are associated with a greater risk.
20% of the patients will be under the age of 40, and 30% over the age of 60, and throughout the trial, close monitoring of all volunteers and identification of all COVID-19 cases found will be carried out throughout the trial. go producing. This will allow preliminary analyzes to be carried out with intermediate data.
Of course, from the AEMP they have explained that, however, it will be necessary to wait until the clinical trial has finished to be able to analyze all the data and draw final conclusions.
These clinical trials are part of the requirements that must
carry out all investigational vaccines to demonstrate their
quality, safety and efficacy. Only after having been evaluated and if
comply with regulatory standards, they will be authorized for their
This vaccine, called Ad26.COV2.S, is based on a technology
well documented with a non-replicative recombinant adenovirus,
to generate an immune response to one of the coronavirus proteins known as protein S –spike, also called spike protein in Spanish–.
The Ministry of Health, through the AEMPS, maintains contact with
different companies that have proposed the inclusion of Spanish centers
in its clinical trials to contribute to the global effort in the search for the vaccine against COVID-19.
The start of clinical trials is, according to what has been pointed out by the department headed by Salvador Illa, another milestone on this path that should end with the eventual authorization and availability of safe and effective vaccines to the public.