AN unknown number of volunteers have dropped out of the US drugmaker Johnson & Johnson’s COVID-19 vaccine trial in Spain after it was revealed that a participant in the AstraZeneca trial had side effects.
The programme’s lead researcher, Alberto Borobia, said, “Many have called to ask us more details about the risk of the vaccine if what happened with that vaccine had something to do with the one we are studying, those kinds of questions.”
The scientist did not detail how many people withdrew from the vaccine trial, although he assured that there are still enough volunteers left for the trials to continue with normality to develop a drug against the new disease, which has already left more than 935,000 deaths and about 29, 5 million infected worldwide.
Borobia explained that phase 2 vaccine trial is designed to determine which doses and schedules of the vaccine generate the most antibodies, while phase 3 tests the efficacy of the vaccine. In this sense, he detailed that the J&J phase 2 trials are scheduled to last between 14 and 16 months, ensuring that if some doses and programs generate considerable amounts of antibodies, a phase 3 “intermediate analysis” could be performed before finish the second stage.
Likewise, he specified that in the third phase the volunteers will be much more diverse than in phase 2, which only involves people in good health divided into two groups, one aged 18 to 55 and the other 65 years or older.
“In the third phase we will include all kinds of people, ” he said. “It is necessary to include a certain number of hypertensive patients, white patients, Asian patients,” he continued, underlining that the population participating in phase 3 of the vaccine trial “is totally heterogeneous.”
On September 6, the British pharmaceutical company AstraZeneca suspended worldwide trials of its coronavirus vaccine after registering a serious side effect in a volunteer in the UK.
Eight days later, the company resumed its vaccine trial in the UK and Brazil after national regulators gave the green light. However, these remain suspended in the US pending a corresponding investigation by the health authorities.
Johnson & Johnson was one of nine companies that last week pledged to uphold scientific standards in the race for a COVID-19 vaccine, amid growing concern that safety and efficacy standards might not be met. in the rush to stop the current pandemic.
The goal of the company is evaluating 60,000 people worldwide during phase 3, with one-third of volunteers in Latin America. The first doses of the drug could be available early next year.
Janssen Biotech, a subsidiary of J&J, began a phase 2 vaccine trial of its vaccine on 190 people in Spain on Monday, which should conclude on September 22. In parallel, trials are being carried out in the Netherlands and Germany, with 360 participants between the two countries.
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