December 21, 2020 -- Johnson & Johnson has fully enrolled 45,000 participants in phase III of its clinical trials for a coronavirus vaccine and hopes to apply for an emergency use authorization from the FDA in February, the company says in a news release.

Data from phase III trial is expected to be available by the end of January, the company says.

“If the data indicate the vaccine is safe and effective, the company expects to submit an emergency use authorization application to the U.S. Food and Drug Administration in February. Other health regulatory applications around the world will be made in parallel,” the news release says.

Johnson & Johnson trails Pfizer-BioNTech and Moderna in the race to put a COVID-19 vaccine on the market. 

Pfizer’s vaccine got an emergency use authorization (EUA) on Dec. 11 and was injected into the arms of American health care workers this week. The FDA granted an EUA to Moderna on Friday, a day after an advisory panel recommended its use.

The Johnson & Johnson vaccine differs from the Pfizer and Moderna ones in that it doesn’t need to be frozen and requires only one dose, not two.

Johnson & Johnson paused clinical trials in the fall because a participant developed an “unexplained illness.” Trials were restarted 2 weeks later.

The company said “no clear cause” was identified. “There are many possible factors that could have caused the event,” it said in a statement.

Johnson & Johnson said earlier this month that it would reduce the number of phase III participants from its original goal of 60,000, Reuters reported.

“Given the high incidence of COVID-19 among the general population in the countries where the trial is being conducted, this number of participants will be sufficient to generate the data needed to determine the efficacy and safety of the company’s investigational COVID-19 vaccine candidate,” Johnson & Johnson said in its news release.

Show Sources

Johnson & Johnson: “Johnson & Johnson Announces Its First Phase 3 COVID-19 Vaccine Trial ENSEMBLE is Fully Enrolled”

Reuters: “J&J enrolls about 45,000 participants for late-stage COVID-19 vaccine trial”

FDA: “FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine.”

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