Panel OKs J&J booster for all adults
An independent FDA panel has unanimously recommended authorization of a Johnson & Johnson booster dose for everyone 18 years and older at least two months after their first shot.
Johnson & Johnson representatives told the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee that the that J&J vaccine is durable against coronavirus and has not waned, but a second dose bumped protection against symptomatic COVID-19 to 94% from 70% in the U.S.
The company originally suggested that the booster should be given six months after the first dose, which VRBPAC members questioned due to lack of data, and ultimately decided on the two month minimum time interval.
Some of the experts said the short two month interval makes the J&J shot more of a two-dose regimen like the mRNA vaccines. “I think this frankly was always a two-dose vaccine,” said FDA adviser Dr. Paul Offit of Children’s Hospital of Philadelphia. “It would be hard to recommend this as a single-dose vaccine at this point.”
But Johnson & Johnson likely won’t be willing to let go of its oneshot claim to fame, and such a change wasn’t on the table on Friday.
The VRBPAC recommendation is much different from the one granted to Pfizer and Moderna boosters. Those shots are for people 65-plus, those with certain medical conditions and people facing workplace exposure whereas the Friday recommendation for the J&J shot is for everyone older than 18.
VRBPAC members noted that this could make for challenging communication to the public.
The FDA committee recommended authorization of Moderna’s booster on Thursday and J&J’s on Friday. The two companies will now face yet another rigorous data review, this time from a Centers for Disease Control and Prevention panel before they make their way into the public.
Following Friday’s vote, committee members heard a presentation from the National Institutes for Health on mixing and matching vaccine doses from different drug makers. The data suggested that J&J recipients may have a far stronger immune response from an mRNA booster, likely unwelcome news for the company.
Overall, the mix and match study showed an increase in antibodies following a booster shot regardless of what the participant had received for their primary shot, and no significant safety concerns were reported.
In fact, mixing the shots had “as good or higher” neutralizing antibodies, according to Dr. Kirsten Lyke of the University of Maryland, who presented the information.