FDA advisory panel endorsed booster doses of Johnson & Johnson’s single-shot COVID-19 vaccine Friday.
The decision comes as U.S. health advisers tackled who should get boosters of Johnson & Johnson’s single-shot COVID-19 vaccine and when — and whether using a competing brand for the second dose might provide better protection.
The push for boosters kicked off last month after the Food and Drug Administration authorized third doses of the Pfizer vaccine for seniors and younger adults with health problems, jobs or living conditions that place them at higher risk from the coronavirus. On Thursday, an FDA advisory panel unanimously recommended a half-dose booster of the similar Moderna vaccine for the same groups.
Moderna and Pfizer asked the FDA to OK boosters at least six months after immunization, but J&J proposed a sliding schedule with an extra dose as early as two months later.
Adding another twist, the experts also will discuss preliminary data from a government “mix-and-match” study that suggested J&J recipients may have a far stronger immune response if they get either a Moderna or Pfizer booster rather than a second J&J dose.
J&J’s single-shot vaccine is made with a different technology than the two-shot Pfizer and Moderna vaccines — and it has consistently shown lower effectiveness levels.
On Friday, J&J executives pitched a booster as a way to strengthen a robust vaccine that they said has retained its protective power over eight months. But FDA scientists pointedly challenged that assertion.
“There are data that suggest the effectiveness of this vaccine is actually less robust than the company’s presentation here,” said Dr. Peter Marks, FDA’s top vaccines official. “And that is a finding of concern particularly because that’s been seen in minority communities potentially and others.”
The panel’s chair said regulators have a responsibility to shore up protection for J&J recipients.
“There is some urgency here to do something,” said Dr. Arnold Monto of the University of Michigan.
The FDA will use its advisers’ recommendations to decide whether to authorize boosters for both J&J and Moderna, after which another government agency will rule on who should roll up their sleeves.
All three vaccines in the U.S. still offer strong protection against severe illness and death from COVID-19 — and the nation’s priority remains getting first doses to 66 million eligible but unvaccinated Americans who are most at risk as the extra-contagious delta variant continues to circulate.
J&J presented results from a large study that found giving a second dose just two months after the first bumped protection against symptomatic COVID-19 to 94% from 70% in U.S. recipients. Giving that booster six months later instead prompted an even bigger jump in virus-fighting antibodies.
But in their own review, FDA scientists flagged a number of shortcomings with J&J’s booster studies, including only a tiny portion of cases involving the delta variant, by far the dominant strain in the U.S. Reviewers also warned that J&J had only followed booster recipients for a little more than a month after a second dose, making it hard to draw conclusions about the durability of protection. Finally, FDA staff emphasized that they had not had time to independently confirm J&J’s findings, which were submitted shortly before the meeting.
FDA’s reviewers found no new safety concerns after a second J&J dose, but again, they cautioned about the small number of patients studied and short follow-up period.
The J&J vaccine was highly anticipated for its one-and-done formulation. But its rollout earlier this year was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In both cases, regulators decided the shot’s benefits outweighed those risks.
The vast majority of the 188 million Americans who are fully vaccinated against COVID-19 have received the Pfizer or Moderna options, while J&J recipients account for only about 15 million.