One-dose J&J COVID vaccine poised for FDA green light after advisory panel OK

WASHINGTON — A Food and Drug Administration advisory panel on Friday gave its green light to a COVID-19 vaccine from Johnson & Johnson, signaling that states will soon see a third vaccine option in their weekly shipments — and the first that only requires one shot.

Emergency-use authorization from the FDA is expected to swiftly follow the unanimous vote by the agency’s Vaccines and Related Biological Products Advisory Committee. 

The shot from Johnson & Johnson’s vaccine division, Janssen Pharmaceuticals, is expected to be pivotal to the national vaccination effort, which has struggled amid too-few vaccines available to meet the massive demand.

So far, more than 46 million Americans have received at least one shot, according to data from the Centers for Disease Control and Prevention. More than 21 million have received both doses of either the Pfizer or Moderna vaccines, which were authorized for emergency use in December.

By requiring just one dose, the Johnson & Johnson vaccine would be a significant help in rural areas and other places where residents are far from vaccination sites, as well as a more efficient option for mass-vaccination sites.

“Essentially, it simplifies the process: People only have to make one appointment for their complete vaccination,” said Gregory Poland, director of the Mayo Clinic’s vaccine research group, who spoke at the meeting as part of J&J’s presentation.

The J&J vaccine also has easier storage requirements than the COVID-19 shots currently in use, which need extra-cold temperatures, and it can be kept in a standard refrigerator for at least three months.

One issue raised during Friday’s day-long virtual hearing was whether a second dose should be added to the Johnson & Johnson vaccine regimen. A second 30,000-person trial is underway to determine the effectiveness of a second dose.

Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, said that Friday’s vote was to authorize the one-dose vaccine, and that the emergency-use authorization could be later amended if the data suggests a second dose would be worthwhile.

Several of the panelists, however, expressed concerns that it could be confusing to those who receive the single dose, and pose challenges to getting those individuals a booster shot later on.

“It seems like a big logistical problem,” said Eric Rubin, editor-in-chief of the New England Journal of Medicine and a professor at Harvard University’s School of Public Health.

Overall, the J&J vaccine was found to provide substantial protection against COVID-19. Data analyzed by FDA officials showed it had a 72% overall efficacy rate in the U.S., and an 85% efficacy against severe disease as early as seven days after it was administered.

There were no COVID-19-related deaths or hospitalizations among those who received the vaccine. Officials also emphasized that the trials included participants in South Africa and Brazil, where several of the more contagious variants emerged.

The company is under contract to provide 100 million doses by the end of June, which would help to reduce a bottleneck of too-few vaccines for the huge national demand. 

Of those doses, 4 million are ready to be shipped as soon as top agency officials grant the emergency use. Company officials have said 20 million doses can be delivered by the end of March.