J&J vaccine efficacy confirmed in review; FDA to meet Friday on final emergency use approval

The U.S. Food and Drug Administration confirmed in a review released Wednesday morning that the Johnson & Johnson COVID-19 vaccine has met the requirements for emergency use authorization.

The analysis was expected — but it does clear the way for the next step of the approval process. That will take place Friday, when an external committee of scientific experts is scheduled to recommend whether the FDA should authorize the shot. A decision could come as soon as this weekend — which means the J&J vaccine could be available as soon as next week.

Since the vaccine requires only one dose to be effective, it will dramatically increase the number of people who will be able to be vaccinated on a daily basis.

Johnson & Johnson is based in New Brunswick.

The review said the efficacy of the Johnson & Johnson vaccine against moderate to severe/critical COVID-19 across all geographic areas was 66.9% at least 14 days after the single dose vaccination. The review said the efficacy after 28 days was 66.1%. Both fall under the acceptable guidelines.

“There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” the analysis said.

While the efficacy rate of the Johnson & Johnson vaccine was much lower than of the two-shot vaccines of both Pfizer and Moderna that currently have been approved, Dr. Richard Marlink, the director of the Rutgers Global Health Institute, told ROI-NJ that the J&J vaccine shot should not be viewed as being less effective.

“These are all home-run vaccines,” Marlink said. “You’re looking at the difference between a BMW and a Mercedes. They’re both unbelievably wonderful cars — and both are not just going to get me where I need to go, they’re going to get me there in style.

“This is not the difference between the old Pinto and a Cadillac.”

As of Tuesday at 4:10 p.m., the state is reporting that 1,713,580 vaccination shots have been given (1,183,627 first doses and 557,458 second doses).

Gov. Phil Murphy and other health officials have said a lack of doses is the main factor in keeping that number lower than is wanted.

When the Johnson & Johnson vaccine is allowed to hit the market, there not only will be more vaccines, but the fact it is a single shot will help the state move through the line faster.