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Johnson & Johnson launches Phase 3 trial of Covid-19 vaccine

 


“A single dose may be enough to protect people for a long time,” he said.

Phase 1/2 trials measure the immune response, but cannot determine if the vaccine actually protects against the virus. Dr. Barauchi said that a single dose of the vaccine, which his previous experiments showed to be sufficient to protect monkeys, produced people’s levels of antibodies.

The company plans to hire up to 60,000 people over the age of 18 for Phase 3 trials in the United States, Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

The trial is about twice as large as Moderna and significantly larger than Pfizer’s. This month, Pfizer announced plans to increase trials from 30,000 to 44,000.

Dr. Barauchi said larger sizes may better understand the safety of the vaccine and reduce the time it takes to determine if the vaccine is effective. “It will provide faster reads,” he said.

Johnson & Johnson posted a blueprint for the exam known as the Protocol on its website on Wednesday, Following the lead He did so after an independent researcher among his competitors asked the company to be more transparent. The protocol showed that the goal of the study was to measure whether the vaccine was 60% effective after 164 participants developed Covid-19.

An external review board can begin assessing the results for efficacy after 20 people have become ill. After that, the committee will check in at least once a week, the protocol says. Without overwhelmingly positive data on safety and efficacy, Dr. Stoffels said the trial would not be stopped early and the data would include patients in high-risk populations such as the elderly. .. Pfizer’s plan was to allow an external committee to confirm the initial validity of the data four times after 32 participants developed Covid-19. Moderna allowed two initial looks, starting with 53 cases.

Johnson & Johnson will test single doses in a study of 60,000 people and will also conduct small trials using double doses.

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