Spain to host phase 2 clinical trial of Johnson & Johnson-made Coronavirus vaccine

chief of clinical trials unit of La Paz University Hospital in Mrid on September 13 said that Spain's first trials of a coronavirus vaccine are scheduled to begin on Monday, September 14. vaccine which is to be tested is developed by United States corporation Johnson & Johnson. According to reports by ANI, phase 1 trials were held in US and Belgium. However, phase 2 trials will take place in Spain, Germany and Belgium again. 

Spain to begin phase 2 of trials

Alberto Borobia said that Marques de Valdecilla hospital in Santander will begin with trials on Monday, September 14. However, La Paz and La Princesa university hospitals in Mrid will take over on Tuesday, September 15. re will be a total of 190 participants for trials. Out of 190, La Paz University Hospital's share will be 50 ults d 18-55 and 25 seniors d over 65. participants will be getting 1-2 shots of vaccine within gap of a month. Doctors will be monitoring participants throughout period of trial. 

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Borobia said, “If everything goes well”, first wave of vaccination will end on September 22. However, final results on vaccine are expected in t less than 16 months. transition to Phase 3 clinical trials was permissible upon satisfactory preliminary results, said Borobia. According to protocols by World Health Organization, to be approved for industrial production, a candidate vaccine has to complete 3 phases of clinical trials.

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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 ir , ethnicity, and or statistically significant factors. It aims at determining optimal dose, intervals between doses, and minimum necessary number of doses in a target population. However, Phase 3, which is also last and final phase can include up to 10,000 participants with maximum representation of target population categories. In this phase, vaccine is rey to move into industrial production.

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(Im Credits: ANI)