The chief of the clinical trials unit of the La Paz University Hospital in Madrid on September 13 said that Spain's first trials of a coronavirus vaccine are scheduled to begin on Monday, September 14. The vaccine which is to be tested is developed by the United States corporation Johnson & Johnson. According to the reports by ANI, phase 1 trials were held in the US and Belgium. However, the phase 2 trials will take place in Spain, Germany and Belgium again.
Alberto Borobia said that the Marques de Valdecilla hospital in Santander will begin with the trials on Monday, September 14. However, the La Paz and La Princesa university hospitals in Madrid will take over on Tuesday, September 15. There will be a total of 190 participants for the trials. Out of the 190, La Paz University Hospital's share will be 50 adults aged 18-55 and 25 seniors aged over 65. The participants will be getting 1-2 shots of the vaccine within the gap of a month. Doctors will be monitoring the participants throughout the period of the trial.
Borobia said, “If everything goes well”, the first wave of vaccination will end on September 22. However, the final results on the vaccine are expected in not less than 16 months. The transition to Phase 3 clinical trials was permissible upon satisfactory preliminary results, said Borobia. According to the protocols by the World Health Organization, to be approved for industrial production, a candidate vaccine has to complete 3 phases of clinical trials.
Phase 1 involves small-scale studies on up to 100 participants. This is to determine a candidate vaccine's safety and clinical tolerance. Phase 2 can take up to 1,000 participants. This phase is more representative in terms of their age, ethnicity, and other statistically significant factors. It aims at determining the optimal dose, intervals between doses, and the minimum necessary number of doses in a target population. However, Phase 3, which is also the last and final phase can include up to 10,000 participants with the maximum representation of target population categories. In this phase, the vaccine is ready to move into industrial production.