Research & Development
Johnson & Johnson expects data from late stage trial of its COVID-19 vaccine for US authorisation by February 2021
18 November 2020 -

The chief scientist of US pharmaceutical company Johnson & Johnson Inc (J&J) (NYSE:JNJ), Dr Paul Stoffels, has said the company is recruiting over 1,000 people per day for the late-stage trial of its experimental COVID-19 vaccine and expects to have all the data needed to seek US authorisation by February 2021 or earlier, Reuters news agency reported on Wednesday.

Stoffels expects an efficacy endpoint should be there in the first few weeks or months, January or February 2021.

This Phase III trial of the company's single-dose vaccine started in late September 2020. The company had paused the trial in October 2020 because of a serious medical event in one participant and resumed after getting the green light from an independent safety panel.

J&J must provide safety data to the US Food and Drug Administration for at least one-half of trial participants for a duration of two months after they receive the vaccine, which will reportedly be around the year end or early next year for the company to have all the data.

Reportedly, J&J's candidate is a single-dose vaccine, whereas the vaccines from rivals Moderna and Pfizer and another under development by AstraZeneca all require two shots separated by several weeks.

"In a pandemic a single shot is definitely important globally," Stoffels said. "(A two-shot vaccine) is a very significant operational challenge. More so in healthcare systems which are less well organised."

Single-shot vaccines will likely benefit in particular remote areas, Stoffels added.