WASHINGTON (AP) — A panel of U.S. health advisers endorsed booster doses of Johnson & Johnson’s single-shot COVID-19 vaccine Friday, saying they should be offered at least two months after immunization.
J&J has asked the Food and Drug Administration for flexibility with its booster, arguing the extra dose adds important protection as early as two months after initial vaccination ― but that it might work better if people wait until six months later.
The FDA’s advisory panel voted unanimously that a booster should be offered without setting a firm time. The advisers cited growing worry that recipients of J&J’s vaccination seem to be less protected than people who got two-dose Pfizer or Moderna options — and that most got that single dose many months ago.
The FDA isn’t bound by the vote but its ultimate decision could help expand the nation’s booster campaign.
All three U.S. vaccines provide strong protection against COVID-19 related hospitalizations, death and other complications. The priority should be getting the first shot to unvaccinated. But there’s a growing push to shore up protection against “breakthrough” infections and the extra-contagious delta variant of the coronavirus.
Booster doses of Pfizer’s vaccine began last month for people at high risk of COVID-19, and the FDA advisory panel has recommended the same approach for Moderna recipients.
THIS IS BREAKING NEWS. AP’s earlier story follows below.
WASHINGTON (AP) — U.S. health advisers on Friday 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.
Last month, boosters were in demand after Pfizer approved the third dose of its vaccine to seniors and those younger than 65 who have health conditions or work that puts them at risk. An FDA advisory panel recommended Thursday that a half-dose booster be given to similar Moderna vaccines for those same populations.
Friday, the same panel discussed a booster of J&J’s vaccine but the decision is more complex. 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. FDA scientists objected to that statement.
“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. You could see an even larger increase in antiviral antibodies if you gave the booster six months after your first dose.
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. The vaccine’s rollout was delayed earlier in the year due to manufacturing issues and side effects. These included a blood disorder called Guillain Barre syndrome and a blood clot disorder. 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.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. All content remains the responsibility of the Associated Press.