Madrid, Aug 28 (efe-epa).- Spanish health officials on Friday authorized the first clinical trials on humans for a coronavirus vaccine in the country.
At a press conference, Spain’s health minister, Salvador Illa, said that the vaccine was being developed by Janssen Pharmaceuticals and that 190 healthy volunteers between the ages of 18 and 55 years of age would take part.
In addition to Spain, another two European countries, Belgium and Germany, will participate in the trial. The first phase of tests were carried out in the United States and Belgium.
Researcher Vicente Larraga at the Spanish National Research Council (CSIC) explained to Efe that in phase one, the safety of a candidate vaccine is tested on a group of between 50 and 100 people, and is the first time the substance is administered to humans after clearing a testing phase on animals.
This stage normally takes at least one year, but that time has been reduced to just over a month due to the urgency presented by the pandemic.
In total, some 550 volunteers from the three EU countries will take part in the trials to evaluate the level of dosages and varying ways to administer the drug.
The clinical trial will last several months and will be followed by another in phase three, the last before the product can be approved for manufacture and distribution.
“Over the coming weeks and months, we will monitor how this evolves,” Illa said.
The vaccine, which has been named Ad26.COV2.S, uses technology baked on a non-replicative recombinant adenovirus to generate an immune response against one of the coronavirus proteins.
The trials are indispensable to guarantee quality, safety and efficacy of the vaccines before they are rolled out for mass production and consumption.
Any vaccine will have to be approved following positive clinical results that have been reviewed by the relevant regulatory bodies before it can be commercialized in Europe, the minister said.
Spain was one of the worst-affected countries in Europe by the coronavirus pandemic, and went into a nationwide lockdown, one of the most severe in the world, from mid-March until June. EFE-EPA