For Covid-19 vaccine, J&J plans 60,000 subject pivotal trial

Johnson & Johnson plans to launch in late September what may be the largest clinical trial to date against a coronavirus vaccine, enrolling up to 60,000 people worldwide to test whether the experimental shot safely protects against Covid-19.

The targeted enrollment, reported on a government database and confirmed by the company, is double the size of other pivotal studies that have recently begun or are expected directly for faxes developed by Moderna Inc., Pfizer Inc. and AstraZeneca PLC.

It is unclear why J&J is planning a much larger late-phase trial than other companies.

A spokesman for J&J said the company wants to “enroll a robust number of participants representative of the populations affected by Covid-19,” and determine the safety, efficacy, sustainability and optimal dosing regimen of the vaccine.

The late-stage tears, like phase 3, coronavirus vaccine depend on a certain number of subjects exposed to the virus to see if the vaccinated subjects were protected against Covid-19 symptoms, compared to the unvaccinated .