The U.S. is poised to have three vaccines available after an FDA advisory panel unanimously recommended that the agency authorize the Ad26.COV2-S vaccine from Johnson & Johnson.
Although the recommendations of the independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) are nonbinding, the agency almost always heeds them. There are 22 members in the panel.
The agency will likely authorize the vaccine quickly.
J&J’s vaccine differs from the mRNA vaccines currently available in that it uses an adenovirus vector, will be available as a single dose and can be stored at typical refrigeration temperatures.
While the vaccine’s overall efficacy of 66% trails that of vaccines from Pfizer and Moderna by nearly 30 percentage points, the vaccine offers strong protection against severe COVID-19 disease.
VRBPAC member Dr. Archana Chatterjee shed light on the panel’s unanimous support of the vaccine, even though some members voiced concerns about it in portions of the day-long meeting leading up to the vote. “Despite the concerns that were raised during the discussion, I think what we have to keep in mind is that we’re still in the midst of this pandemic,” said Chatterjee, who is the vice president for medical affairs at Rosalind Franklin University of Medicine and Science (North Chicago). “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”
As FDA is poised to authorize a growing number of vaccines under its emergency use authorization program, it is important that sponsors continue to provide “new information about the vaccine safety and efficacy,” said Dr. Stanley Perlman, a temporary voting member and professor at the University of Iowa.
Dr. Eric Rubin, a microbiology and molecular biology professor at Harvard, agreed, adding that “it is a bit challenging to know how to use [the J&J vaccine] clinically right now, but the demand is so large that it clearly has a place,” Rubin said. “It is a very changing environment though, so I think having new information coming out constantly will really help us understand how best to apply this [vaccine].”