FDA issued an EUA for J&J’s Ad26.COV2-S vaccine on Feb. 27, a day after an advisory panel unanimously recommended that the agency authorize the vaccine for adults 18 and over. J&J’s vaccine is the third COVID-19 vaccine to receive authorization in the U.S. so far.
“Literally it’s on trucks as we’re talking,” Gorsky told Today. There are 4 million doses being shipped at this time, with plans to ship a total 20 million by the end of March and 100 million by the end of June.
“We believe our COVID-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible,” said Dr. Paul Stoffels, chief scientific officer of Johnson & Johnson.
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.
Johnson & Johnson will make the vaccine available during the pandemic on “a not-for-profit basis.”
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. Clinical trial data suggest that the vaccine offers full protection against COVID-19-related death and hospitalization.
The vaccine’s efficacy level could convince some potential recipients that it is an inferior alternative to currently authorized mRNA vaccines, according to The New York Times. “People will want to know: Why is this one so much less and what does it mean for us? I’m worried it’s going to cause more questions than confidence,” Rupali Limaye, a professor who studies vaccine hesitancy at Johns Hopkins University told the paper,
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 VP 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].”
This article originally ran on Feb. 26, 2021. Updated Feb. 27 with news of the FDA emergency use authorization — and March 1 with J&J CEO Alex Gorsky discussing vaccine distribution.
Filed Under: Infectious Disease