A panel of experts said the agency should authorize emergency use of the single-dose vaccine that is easier to transport and store.
(CN) — A panel of Food and Drug Administration experts voted unanimously on Friday in favor of approving Johnson & Johnson’s Covid-19 vaccine for emergency use in American adults.
The vote came after an FDA report on Wednesday said the J&J vaccine is safe to use and overall 66% effective. In clinical trials, no participants died or were hospitalized from severe Covid-19 symptoms, early data shows.
If the FDA follows the panel’s recommendation and approves the J&J vaccine for emergency use, as is expected, it will be the first one-dose vaccine administered in the U.S., and the third option after the two-dose Pfizer and Moderna vaccines.
The J&J vaccine could be promising for delivery to remote or rural areas since it can be stored at normal refrigeration temperatures. Freezing requirements for the two vaccines currently in use has tripped up distribution efforts.
After hours of questions for the vaccine creators, the panel was posed with the question: “Based on the totality of scientific evidence available, do the benefits of the Janssen Covid-19 vaccine outweigh its risks for use in individuals 18 years of age and older?”
All 22 health advisers on the panel voted yes, with zero voting no or abstaining.
In discussion surrounding the vote, several panelists pointed out their increasing comfort and relief in seeing the outcome of early vaccine distribution, saying there have been no surprises in terms of efficacy and safety.
Dr. Arnold Monto, chair of the panel and an epidemiologist at the University of Michigan School of Public Health, added that the approval process has also gotten better over time.
“We are very comfortable now with the procedure,” he said, “as well as the vaccines we are approving.”
The unanimous decision was not a tough one to make, chimed in Dr. Eric Rubin from the Harvard T.H. Chan School of Public Health.
“It’s a relatively easy call,” Rubin said. “It clearly gets way over the bar, and it’s nice to have a single-dose vaccine.”
Rubin noted that questions remain about how exactly to implement the vaccine, but said that “the demand is so large, it clearly has a place.”
One of the key clinical issues has to do with the ideal number of doses of the J&J vaccine to ensure protection against the coronavirus.
Although it has touted the benefits of a single-dose vaccine, J&J has also been conducting two-dose clinical trials. Those results won’t be available until at least July, prompting members of the FDA panel to ask what happens next.
Dr. Paul Offit of the Children’s Hospital of Philadelphia noted that a study in the New England Journal of Medicine found that a second dose of vaccine increased neutralizing antibodies nearly threefold — “which may well confer more protection,” he said.
If there is indeed a better response with two doses, Offit asked, “Does this then become a two-dose vaccine?”
Speaking on behalf of J&J’s vaccine development team, Dr. Johan Van Hoof responded by saying the company chose to pursue the single-dose trials first and in full, after trials in monkeys showed that protection against Covid-19 lasted four months after the shot was administered.
Offit noted that there could be a “messaging challenge” in the future if administration of the vaccine were to change course.
Several panelists acknowledged that the situation surrounding the coronavirus will continue to change no matter what, as new strains of virus emerge, and take over, and more vaccine options become available.
Among them was Dr. Archana Chatterjee, dean of Chicago Medical School.
“We are in such a fluid situation,” Chatterjee said, “that what happens two, four, six months down the road is going to be very difficult for anyone to really say for sure.”
As things continue to unfold on the North American vaccine front, Canada on Friday approved use of the Oxford-AstraZeneca vaccine. The decision adds a third option, in addition to the Pfizer and Moderna versions being used in the country.