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J&J planning 60K-subject study to test COVID-19 vaccine

August 20, 2020

Johnson & Johnson (JNJ +0.3%) is going big on its Phase 3 trial testing COVID-19 vaccine candidate, Ad26.COV2.S. The study, expected to launch by late September, will recruit up to 60K people, twice as many as other vaccine developers such as Pfizer (PFE +0.5%)/BioNTech (BNTX +1.6%), Moderna (MRNA -1.4%) and AstraZeneca (AZN +0.3%).

The company has not disclosed the specific reasons behind the bigger study which, by definition, will be more expensive and time-consuming, although a spokesperson said that it wants “to enroll a robust number of participants who are representative of those populations affected by COVID-19,” and to determine the safety, efficacy, durability and optimal dosing regimens of the vaccine.

According to Vanderbilt University School of Medicine’s William Schaffner, achieving the numbers needed to show that the vaccine works could happen more quickly if more people are enrolled.

J&J is using epidemiology and modeling data to plan the locations of ~180 trial sites in the U.S. and eight other countries with high rates of COVID-19. Recruitment is underway. Participants will be followed for two years but preliminary results will be available much sooner.

A big selling point of Ad26.COV2.S is that it is a single shot instead of two.

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