FDA panel takes up tough questions on J&J COVID-19 boosters

WASHINGTON – U.S. wellness advisers connected Friday tackled who should get boosters of Johnson & Johnson’s single-shot COVID-19 vaccine and erstwhile — and whether utilizing a competing marque for the 2nd dose mightiness supply amended protection.

The propulsion for boosters kicked disconnected past period aft the Food and Drug Administration authorized 3rd doses of the Pfizer vaccine for seniors and younger adults with wellness problems, jobs oregon surviving conditions that spot them astatine higher hazard from the coronavirus. On Thursday, an FDA advisory sheet unanimously recommended a half-dose booster of the akin Moderna vaccine for the aforesaid groups.

Friday, the aforesaid sheet discussed a booster of J&J's vaccine — but the determination is much complex. Moderna and Pfizer asked the FDA to OK boosters astatine slightest six months aft immunization, but J&J projected a sliding docket with an other dose arsenic aboriginal arsenic 2 months later.

Adding different twist, the experts besides volition sermon preliminary information from a authorities “mix-and-match” survey that suggested J&J recipients whitethorn person a acold stronger immune effect if they get either a Moderna oregon Pfizer booster alternatively than a 2nd J&J dose.

Ad

The FDA volition usage its advisers’ recommendations to determine whether to authorize boosters for some J&J and Moderna, apt adjacent week, aft which different authorities bureau volition regularisation connected who should rotation up their sleeves.

All 3 vaccines successful the U.S. inactive connection beardown extortion against terrible unwellness and decease from COVID-19 — and the nation's precedence remains getting archetypal doses to 66 cardinal eligible but unvaccinated Americans who are astir astatine hazard arsenic the extra-contagious delta variant continues to circulate.

But experts proceed to statement whether there’s worth successful utilizing boosters to caput disconnected milder infections successful astir vaccinated adults, an attack projected by the Biden administration.

FDA scientists precocious flagged shortcomings successful the information J&J submitted successful applying for a booster dose, including small information connected the spot of extortion successful radical who got a six-month booster. A reappraisal released earlier this week said a survey of the two-month boost suggests “there whitethorn beryllium a benefit.”

Ad

J&J’s single-shot vaccine has consistently shown little effectiveness than the two-shot mRNA vaccines developed by Pfizer and Moderna, a constituent FDA reviewers noted successful their review. That spread successful extortion is apt to play a cardinal relation arsenic panelists measurement the request and scope of boosters.

The J&J vaccine was highly anticipated for its one-and-done formulation, and it is made with a antithetic exertion than its Pfizer and Moderna competitors. But its rollout was wounded by a bid of troubles including manufacturing problems and immoderate uncommon but superior broadside effects including a humor clot upset and a neurological absorption called Guillain-Barre syndrome. In some cases, regulators decided the shot’s benefits outweighed those risks.

The immense bulk of the 188 cardinal Americans who are afloat vaccinated against COVID-19 person received the Pfizer oregon Moderna options, portion J&J recipients relationship for lone astir 15 million.

Ad

___

The Associated Press Health and Science Department receives enactment from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely liable for each content.

Copyright 2021 The Associated Press. All rights reserved. This worldly whitethorn not beryllium published, broadcast, rewritten oregon redistributed without permission.