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Johnson & Johnson’s trials for a Covid-19 vaccine were interrupted by a still unexplained illness in one of the study volunteers, the company said Monday night (12). The immunizer had entered the final stages (phase 3) of human testing on September 23 in the United States.
The pharmacist noted that an independent committee of professionals who monitor data and safety will analyze the case. The identity of the patient and details of the incident were not disclosed, out of respect for the participant’s privacy, the company added.
According to the company, the patient’s illness is “being analyzed and evaluated by the ENSEMBLE Data Security Monitoring Council (DSMB), as well as by our internal security and clinic physicians.”
The online system used to enroll patients in the study was closed and the data and safety monitoring board convened – the board is an independent body that ensures the safety of patients in the clinical trial.
The study foresees the inclusion of up to 60 thousand volunteers, between 18 and 60 years old, 7 thousand in Brazil – distributed in the states of São Paulo, Rio Grande do Sul, Rio de Janeiro, Paraná, Minas Gerais, Bahia and Rio Grande Del north. For the approval of the tests in the country, Anvisa held meetings with the team of Janssen, Johnson & Johnson’s Belgian pharmacist, in order to align all the technical requirements necessary for the tests.
The study was designed to be twice the size of the initial design of other phase 3 trials in the United States, although the Pfizer study was also expanded to include 44,000 participants. Half of the participants will receive the vaccine and the other half will receive the placebo.
The company also said that these types of occurrences are common in immunization tests, mainly in large-scale studies, and highlighted the commitment to the safety of the participants. The vaccine tested by the pharmaceutical company AstraZeneca and the University of Oxford, in the United Kingdom, also had tests paralyzed on two occasions after manifestations of adverse reactions in research volunteers.
Single dose
Johnson & Johnson plans to produce one million doses next year. The experimental product is one of the few under study in the world that provides a single injection to protect against disease.
Another advantage is that the J&J vaccine can also be stored in liquid form, at refrigerator temperature, for three months, while two of the favorite candidates must be frozen or kept at deep-freeze temperatures for storage, according to information released by the pharmaceutical company . .
(With Agência Estado)
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