Johnson & Johnson Hopes to Offer COVID Vaccine in February

By WebMD News Staff

December 18, 2020

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

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 said in a news release.

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

"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 said.

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

Pfizer's vaccine was authorized Dec. 10 and injected into the arms of American health care workers this week. The FDA is expected to grant an EUA to Moderna any day after an advisory panel recommended its use Thursday.

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

Johnson & Johnson paused clinical trials in the fall because a participant developed an "unexplained illness". Trials were re-started 2 weeks later.

The company said "no clear cause" was identified. "There are many possible factors that could have caused the event," the company 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.