The world’s largest pharmaceutical company, the American Johnson & Johnson (J&J), announced Thursday that it has begun testing its experimental vaccine against COVID-19 in humans after obtaining positive results in a previous study with primates.
In a statement, J&J noted the « data strength » of that study, which shows an immune response in animals with just one dose, and confirmed that the « 1 / 2a » phase of the clinical trial of its study has begun. vaccine, called Ad26.COV2.S, in about 1,000 healthy volunteers in the US and Belgium.
The study was published today in the scientific journal Nature and explains that its prototype of vaccine A single dose generated neutralizing antibodies in rhesus macaques, which successfully prevented infection of COVID-19 and gave their lungs « complete or almost complete » protection against coronavirus.
« We are excited to see these preclinical data because they show that our candidate for vaccine against SARS-CoV-2 it generates a strong immune response and provides protection with a single dose. The findings give us confidence in the progress of the development of the vaccine and the largest scale of production, « J&J chief scientist Paul Stoffels was quoted as saying.
J&J had anticipated that it would start the human testing phase sometime in the second half of July, as it confirmed today that it has done, and reiterated that it plans to enter phase 3 in September.
The firm is evaluating both the vaccine of one dose as another of two doses, and the objective of the phase 1 / 2a that is underway is to know the safety and reactions to treatment, both at the level of inflammation and immunity, in that thousand adults, with groups between 18 and 55 years on the one hand and over 65 on the other.
According to the note, the pharmaceutical company plans to carry out a phase « 2a » in Spain, the Netherlands and Germany, and a phase 1 in Japan, although it did not give more details about these tests.
« There are ongoing discussions with our partners to start a key phase 3 in the clinical trial in which the single dose of vaccine vs. placebo in September, depending on provisional data from phases 1 and 2 and regulatory approval, « J&J explained.
In this phase 3, the pharmaceutical company promised to « emphasize the representation of populations disproportionately impacted by the pandemic », which in the US will involve a « significant » number of black and Hispanic volunteers, as well as people over 65 years. .