Spain authorizes first clinical trials of COVID-19 vaccine on humans

Spanish health officials authorized the first clinical trials on humans for a coronavirus vaccine in the country, EURACTIV’s partner EFE reported.

At a press conference, Spanish Health Minister Salvador Illa confirmed on Friday (28 August) 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 EU member states, Belgium and Germany, will participate in the trial. The first phase of tests were carried out in the US and Belgium.

Researcher Vicente Larraga at the Spanish National Research Council (CSIC) explained to EFE that in phase one, which usually takes at least one year, 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.

Given the urgency of the pandemic, however, phase one was reduced to just over a month.

In total, some 550 volunteers from the three EU countries will take participate in phase two, which should last several months before it will be followed by another trial in phase three, the last before the product can be approved for manufacture and distribution, EFE reported.

“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 vital 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 Europe’s worst-affected countries and went into one of the world’s strictest nationwide lockdowns from mid-March until June. (EUROEFE with EPA)

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