Madrid [Spain]: Spain's first trials of a coronavirus vaccine are scheduled to begin on Monday, Alberto Borobia, the chief of the clinical trials unit of the La Paz University Hospital in Madrid, said on Sunday.
The vaccine to be tested was developed by US corporation Johnson & Johnson. Phase 1 trials were held in the United States and Belgium. The trials in Spain will fall under Phase 2, to be also held in Germany and Belgium.
Three Spanish hospitals will be administering the trials -- the Marques de Valdecilla hospital in Santander will launch then on Monday and the La Paz and La Princesa university hospitals in Madrid will join in on Tuesday, according to Borobia.
The expected pool of participants includes 190 volunteers, of which La Paz University Hospital's share will be 50 adults aged 18-55 and 25 seniors aged over 65, Borobia told Spanish news agency Servimedia.
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The participants will get either one shot of the vaccine or two shots a month apart. There will also be a group that will be given a placebo. Doctors will monitor the participants throughout the entire period of trials. "If everything goes well," Borobia said, the first wave of vaccination will end on September 22.
While the final results on the vaccine's safety and effectiveness are expected no sooner than in 16 months, Borobia said the transition to Phase 3 clinical trials was permissible upon satisfactory preliminary results.
The epidemiological situation in Spain, which used to be Europe's second-worst outbreak at the beginning of the year, worsened again in July. More than 560,000 cases were confirmed by Spanish health authorities, as of Sunday. Over the past week alone, 53,000 new cases were detected and 241 people died from the coronavirus.
According to WHO protocols, a candidate vaccine has to complete three phases of clinical trials to be approved for industrial production.
Phase 1 normally involves small-scale studies on up to 100 participants to determine a candidate vaccine's safety and clinical tolerance. Phase 2 can include up to 1,000 and is more representative in terms of their age, ethnicity, and other statistically significant factors. This phase pursues to determine the optimal dose, intervals between doses, and the minimum necessary number of doses in a target population.
Phase 3 trials are the largest and can include up to 10,000 participants with the maximum representation of target population categories. A candidate vaccine is ready to move into industrial production if this last phase provides clear and definitive evidence of its safety and efficacy.
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