UNITED STATES NEWS

FDA panel endorses booster shot for J&J COVID-19 vaccine

Oct 15, 2021, 11:00 AM | Updated: Oct 17, 2021, 10:08 pm

WASHINGTON (AP) — U.S. health advisers endorsed a booster of Johnson & Johnson’s COVID-19 vaccine Friday, citing concern that Americans who got the single-dose shot aren’t as protected as those given two-dose brands.

J&J told the Food and Drug Administration that an 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. Unable to settle the best timing, the FDA’s advisory panel voted unanimously that the booster should be offered at least two months after people got their earlier shot.

“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.”

The FDA isn’t bound by the recommendation as it makes a final decision — and adding to the debate’s complexity, new research also suggests that J&J recipients might have a stronger immune response if their booster dose is from a competing brand.

Preliminary results from an ongoing study of different ways to “mix and match” different shots showed that a booster of any sort revved up people’s levels of virus-fighting antibodies — at least for a few weeks. And the most dramatic jump came from giving a Pfizer or Moderna shot after the single-dose J&J vaccination.

FDA’s advisers didn’t vote on whether that should be recommended but told the government to allow flexibility with boosters, saying there were no safety red flags even if it’s not yet clear just how much difference, if any, mixing and matching may make in long-term protection.

“In the real world all these kind of combinations are already happening so I think it’s a matter of some urgency for the FDA to help sort out what is admittedly a complicated and challenging scenario,” said Dr. Ofer Levy of Boston Children’s Hospital.

The government says all three U.S. vaccines continue to offer strong protection against hospitalization and death from COVID-19, and that the priority is getting first shots to the 66 million eligible but unvaccinated Americans who are most at risk. But with the spread of the extra-contagious delta variant and signs of waning immunity against milder infections, the nation is moving toward a broader booster campaign.

Last month Pfizer boosters started being offered to seniors and younger adults at high risk from COVID-19 because of poor health, jobs or living conditions — at least six months after their initial vaccination. Thursday, the FDA advisory panel recommended the same approach for half-dose Moderna boosters.

But J&J’s vaccine has consistently shown lower effectiveness levels across a series of studies — and the FDA panel ultimately settled on another shot for any recipient 18 or older at least two months after their first vaccination.

“This is really — with the second dose — bringing it, I think, on par with those other vaccines in terms of effectiveness,” said Dr. Archana Chatterjee of Rosalind Franklin University.

The FDA will use its advisers’ recommendations to decide whether to authorize boosters for both J&J and Moderna. Next, the Centers for Disease Control and Prevention would rule on who should roll up their sleeves.

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.

J&J’s vaccine is made with a different technology and on Friday, the company pitched its 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.”

As for its booster, 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 noted only a tiny portion of cases involved the delta variant, by far the dominant strain in the U.S. And while FDA’s reviewers found no new safety concerns about a second J&J dose, they noted other shortcomings. J&J followed booster recipients for little more than a month, making it hard to draw conclusions about the durability of protection. Also, FDA scientists stressed they hadn’t had time to independently confirm J&J’s data, which were submitted shortly before the meeting. That’s highly unusual and drew serious concern from the advisory panel.

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

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

United States News

The image from video released on Jan. 27, 2023, by the City of Memphis, shows Tyre Nichols on the g...
Associated Press

Memphis authorities release video in Tyre Nichols’ death

Video showing Memphis officers beating a Black man was made public Friday after they were charged with murder in the death of Tyre Nichols.
2 days ago
Demonstrators stage a rally in front of the White House to celebrate President Joe Biden's plan to ...
Kevin Stone

Lawsuits keeping over 300,000 Arizonans from getting student loan relief

Lawsuits are preventing more than 300,000 Arizonans from having some or all of their student debt dismissed, the Biden administration said Friday.
2 days ago
FILE -  A Goodyear tire sits on display at a tire shop on Feb. 12, 2014, in South Euclid, Ohio. A f...
Associated Press

Arizona lawyer subpoenaed in criminal investigation of Goodyear tires

A federal grand jury in Los Angeles is gathering evidence in a criminal investigation of Goodyear recreational vehicle tires.
3 days ago
Following days of rain, floodwaters cover streets in the Planada community of Merced County, Calif....
Associated Press

Atmospheric rivers in California boost water allocation for cities

Public water agencies in California will be getting more water from the state because of recent heavy rain.
3 days ago
(Brian Munoz/St. Louis Post-Dispatch via AP, File)...
Associated Press

FDA declines to regulate CBD; calls on Congress for fix

The Food and Drug Administration said Thursday there are too many unknowns about CBD products to regulate them as foods or supplements under the agency’s current structure and called on Congress to create new rules for the massive and growing market. The marijuana-derived products have become increasingly popular in lotions, tinctures and foods, while their […]
3 days ago
FILE - An employee works in the battery assembly hall at the BMW Spartanburg plant in Greer, S.C., ...
Associated Press

US economy slowed but still grew at 2.9% rate last quarter

WASHINGTON (AP) — The U.S. economy expanded at a 2.9% annual pace from October through December, ending 2022 with momentum despite the pressure of high interest rates and widespread fears of a looming recession. Thursday’s estimate from the Commerce Department showed that the nation’s gross domestic product — the broadest gauge of economic output — […]
3 days ago

Sponsored Articles

(Pexels Photo)...

Sports gambling can be fun for adults, but it’s a dangerous game for children

While adults may find that sports gambling is a way to enhance the experience with more than just fandom on the line, it can be a dangerous proposition if children get involved in the activity.
...
Day & Night Air Conditioning, Heating and Plumbing

Prep the plumbing in your home just in time for the holidays

With the holidays approaching, it's important to know when your home is in need of heating and plumbing updates before more guests start to come around.
...
Quantum Fiber

Stream 4K and more with powerful, high-speed fiber internet

Picking which streaming services to subscribe to are difficult choices, and there is no room for internet that cannot handle increased demands.
FDA panel endorses booster shot for J&J COVID-19 vaccine