A panel of expert advisers to the U.S. Food and Drug Administration voted Friday to recommend the approval of Johnson & Johnson’s one-dose COVID-19 vaccine for emergency use, bringing it to an important step closer to a U.S. launch.
The FDA is likely to approve the vaccine for emergency use within a day or so, making it the third available in the United States and the only one that requires a single shot.
The panel of doctors, infectious experts and medical researchers voted unanimously that the benefits of the vaccine outweigh its risks in people 18 years and older.
“We believe that our COVID-19 vaccine candidate has the potential to help change the path of the pandemic and be ready to make it available to protect the public as soon as possible,” said Dr. Paul Stoffels, J & J’s scientific director in a statement.
The company said it is ready to deliver its vaccine immediately if it receives an emergency use permit (EUA), as expected. J&J has said they will be able to send three million to four million doses of their vaccine next week.
The company expects to have enough assets to vaccinate 20 million people by the end of March.
Senior White House adviser Andy Slavitt tweeted that the FDA would meet to complete the EUA on Saturday. “A third safe and effective vaccine is very welcome news,” he said.
More than 50 million vaccine shots have been administered nationwide, a milestone that President Joe Biden emphasized on Thursday.
But the emergence of highly contagious new virus variants has only increased the urgency to get hundreds of millions more people inoculated against a virus that has killed more than half a million people in the United States.
Panelist Jay Portnoy, a professor of pediatrics at the University of Missouri-Kansas City School of Medicine, said the race is underway to stop the pandemic before new virus variants cause further illness.
“The fewer people who are infected with the virus, the less chance it has of emerging as a more virulent strain. So we are in a hurry to get this vaccine out,” he said.
The head of the US Centers for Disease Control and Prevention on Friday expressed concern that a recent decline in US COVID-19 cases could stop.
In a trial of 44,000 people, the J&J vaccine was 66% effective in preventing moderate to severe cases of COVID-19 compared to placebo.
Two-dose vaccines manufactured by Pfizer Inc with BioNTech SE and Moderna Inc were approximately 95% effective in their core trials.
Experts warned against making too much difference between the vaccines because the studies had slightly different goals, and more importantly, the Pfizer / BioNtech and Moderna studies were conducted before the more transmissible virus variants had emerged in South Africa, Brazil and the United Kingdom.
J & J’s trial was ongoing when the new variants circulated and were even widespread in some countries where it was tested.
Nevertheless, its vaccine was 100% effective in preventing hospital stays 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.
During the meeting, a J&J vaccine manager said that the company was developing a second-generation vaccine that would target the South African variant and will be ready to start phase I trials this summer.
The J&J vaccine can be stored in normal refrigerator temperatures, which makes distribution easier than for Pfizer / BioNTech and Moderna shots that use messenger RNA technology and are delivered frozen.
J & J’s vaccine uses a cold virus called adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.