Spain’s first trials of a coronavirus vaccine developed by US firm Johnson & Johnson are scheduled to begin today (September 14).
THREE hospitals are carrying out the clinical trials – the Marques de Valdecilla Hospital in Santander and La Paz and La Princesa university hospitals in Madrid.
The first phase of the tests took place in the US and Belgium, with Spain joining Belgium and Germany for the second phase.
Some 190 volunteers are expected to take part, with 75 adults from La Paz, the hospital’s head of the clinical trials, Alberto Borobia told Spanish news agency, Servimedia.
Fifty of these participants will be aged 18 to 55 with 25 aged over 65.
He explained they will each receive either one shot of the vaccine or two shots a month apart.
Some volunteers will be given a placebo, and doctors will monitor all of those taking part throughout the trials.
It is hoped the first round of vaccination will be completed by the end of September.
According to Borobia, though the final results are expected no sooner than in 16 months, the move to phase three was given the go ahead upon “satisfactory preliminary results.”
World Health Organisation (WHO) stipulates that a potential vaccine must complete three phases of clinical trials to be approved for mass production.
The first phase is is on a smaller scale with around 100 volunteers to determine safety and clinical tolerance.
Phase two is on a larger scale, with up to 1,000 participants of different ages, ethnicity and other factors. Dose levels and intervals are also determined during this stage.
As the trials move to phase three, up to 10,000 volunteers can be involved, with the maximum representation of target population categories.
Definitive evidence of safety and the capacity to produce the desired result or effect is necessary before a candidate vaccine can move into industrial production.
The pandemic is on the rise in both Spain and in the UK with both countries having reported over the last few days the highest number of positive cases since March.