Spain Gives Go-Ahead For Johnson & Johnson Phase III COVID Vaccine Trials Starting ‘As Soon As Possible.’
The Ministry of Health has announced that the Agency for Medicines and Health Products (AEMPS) has authorized the first phase III clinical trial for the vaccine against covid-19 from Janssen, a company belonging to the multinational corporation Johnson & Johnson.
This is the first phase III trial of this type authorized in Spain. The safety of this vaccine will be studied and will also be tested in eight other countries and up to 30,000 volunteers will be recruited. In addition to Spain, other participating countries are Belgium, Colombia, France, Germany, the Philippines, South Africa, the United Kingdom and the United States.
The planned trial will consist of two doses of vaccine and will be carried across nine hospital centres and will begin as soon as possible. As is normal in these procedures, the volunteers must meet strict criteria before that can be entered in the trials. 20% of the patients will be under 40 years old, and 30% over 60 years old. Throughout any trial, close monitoring of all volunteers and identification of all cases will be carried out, says the ministry of health.
It is understood that some volunteers suddenly quit Johnson & Johnson’s COVID-19 vaccine trial in Spain after recent news of side effects in a participant in AstraZeneca’s trial, the Spanish programme’s lead investigator told the Reuters news agency on Tuesday. The investigator, Alberto Borobia, said there were enough reserve volunteers for the trial to continue as normal, however.
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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