J&J expects information for US approval of COVID-19 antibody by February, says head researcher

J&J expects information for US approval of COVID-19 antibody by February, says head researcher


  • Post By : Kumar Jeetendra

  • Source: Reuters

  • Date: 18 Nov,2020

Johnson & Johnson’s chief scientist said the drugmaker is recruiting over 1,000 people per day for the late-stage trial of its experimental COVID-19 vaccine and hopes to have all the data required to seek U.S. authorization by February or earlier.

“From the end of the year or around the end of the year, we should have 60,000 people in the study,” Dr. Paul Stoffels, J&J’s chief scientific officer, said in an interview before the week’s Reuters Total Health conference.

“And efficacy endpoint should be there in the first few weeks or months, January or February, of the new year,” he added.

The Phase III trial of this single-dose vaccine started in late September. The business paused the trial in October due to a serious medical event in one participant and resumed after getting the green light from an independent security panel.

J&J must provide security data to the U.S. Food and Drug Administration for at least one-half of trial participants for a period of 2 months when they get the vaccine. “So that will bring us around the year end or early next year for having all the information,” he added.

J&J lags a number of its rivals in the worldwide race to develop a safe and effective vaccine against the virus that has killed over 1.3 million individuals worldwide and roiled the international economy.

Rival Moderna on Monday said its experimental vaccine was 94.5% effective in preventing COVID-19 based on interim data from a late-stage clinical trial, following similar results in Pfizer last week.

Both Pfizer’s and Moderna’s vaccines use a new technology called messenger RNA, or mRNA. By contrast, J&J’s vaccine uses a common cold virus called adenovirus type 26 to introduce coronavirus proteins into cells in the body and activate the body’s immune system.

“In a pandemic one shot is unquestionably important worldwide,” Stoffels said.” (A two-shot vaccine) is a really significant operational challenge. More so in healthcare systems which are less well organized.”

Single-shot vaccines will probably benefit in particular remote places, Stoffels said.

About Author