CORONAVIRUS

More questions for J&J vaccine boosters ahead of FDA review

Oct 14, 2021, 5:52 AM

FILE: In this photo illustration, Health Department employee, Janet Gerber, holds the first vial of...

FILE: In this photo illustration, Health Department employee, Janet Gerber, holds the first vial of the Janssen COVID-19 vaccine at Louisville Metro Health and Wellness headquarters on March 4, 2021, in Louisville, Kentucky. (Photo Illustration by Jon Cherry/Getty Images)

(Photo Illustration by Jon Cherry/Getty Images)

WASHINGTON (AP) — The Food and Drug Administration is wrestling with whether and when to offer another dose of the single-shot Johnson & Johnson COVID-19 vaccine, while a new study out Wednesday raises the prospect that using a different brand as the booster might work better.

In an online review posted Wednesday, FDA scientists didn’t reach a firm conclusion about whether there’s enough evidence for J&J boosters, citing shortcomings with the company’s data and little information on protection against the extra-contagious delta variant of the coronavirus.

The review comes ahead of meetings Thursday and Friday when an FDA advisory panel will recommend whether to back booster doses of both the J&J and Moderna vaccines. That’s one step in the government’s vaccine review process: Next week, the FDA will make a final decision on authorizing those boosters and then the Centers for Disease Control and Prevention will debate who actually should get them.

Adding to the complexity is whether it’s OK to use a booster that’s a different brand than someone’s initial shots. Preliminary results of a U.S. government study suggest that mixing and matching boosters will work at least as well — and maybe far better for J&J recipients. Those people had a stronger immune response if they got either a Moderna or Pfizer shot as their booster than if they received another dose of the J&J vaccine, according to results posted online Wednesday. Mix-and-match is also up for discussion by the FDA panel this week.

Health authorities say all the vaccines used in the U.S. continue to provide strong protection against severe disease or death from COVID-19. But amid signs that protection against milder infections may be waning, the government already has cleared booster doses of the Pfizer vaccine for certain people starting at six months after their last shot.

Aiming for uniform recommendations, Moderna likewise asked the FDA to clear its booster dose at six months. But J&J complicated the decision by proposing a second shot over a range of two to six months.

FDA reviewers wrote that a study of the two-month booster plan suggests “there may be a benefit,” while pointing to only small numbers of people who got another shot at six months instead.

Overall, the J&J vaccine “still affords protection against severe COVID-19 disease and death,” the FDA’s reviewers concluded. But data about its effectiveness “are consistently less” than the protection seen with Pfizer and Moderna shots.

For its part, J&J filed data with the FDA from a real-world study showing its vaccine remains about 80% effective against hospitalizations in the U.S.

J&J’s single-dose vaccine was highly anticipated for its one-and-done formulation. But its rollout 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.

Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with those companies’ two-dose shots while less than 15 million Americans got the J&J shot.

___

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.

KSL 5 TV Live

Coronavirus

FILE - Comirnaty, a new Pfizer/BioNTech vaccination booster for COVID-19, is displayed at a pharmac...

Jen Christensen, CNN

The FDA tells COVID-19 vaccine makers to update shot to target newest variant

The US Food and Drug Administration announced Friday that it had advised the makers of the Covid-19 vaccines to formulate their new shots to be a better match for the JN.1 lineage of the coronavirus.

9 days ago

(FILE) A test dummy getting hit by an air bag during a crash test....

Matt Gephardt and Sloan Schrage, KSL TV

Thousands of cars equipped with faulty airbags on Utah roads as automakers issues ‘Do Not Drive’ warnings

Auto manufacturers have recalled over millions of Takata airbags because of their potential to explode and shoot out sharp metal fragments. And there are still thousands of those in cars across Utah.

11 days ago

WASHINGTON, DC - JUNE 03: Dr. Anthony Fauci, former Director of the National Institute of Allergy a...

Lauran Neergaard, AP Medical Writer

Fauci testifies publicly before House panel on COVID origins, controversies

Dr. Anthony Fauci is facing heated questioning from Republican lawmakers about the origins of the COVID-19 pandemic.

13 days ago

A sign reminding Copper Hills High School students and staff to keep their hands clean during the c...

Lindsay Aerts

Utah school districts working to prioritize what stays when COVID relief money runs dry

Utah's school districts are working to figure out how they will continue to pay for programs propped up by COVID-19 relief funds.

1 month ago

FILE: Former Utah Jazz John Stockton reacts during a 76-70 Wichita State win over the Gonzaga Bulld...

Michael Houck

Former Utah Jazz star John Stockton sues Washington medical director about COVID misinformation policy

Former Utah Jazz superstar John Stockton has filed a federal lawsuit against Washington officials on First Amendment violations, arguing the state's policy of COVID-19 misinformation is unconstitutional.

3 months ago

Deer Creek Reservoir...

Alex Cabrero

State parks expecting another record visitation year, hiring more workers

It didn't matter how cold or snowy it was at Deer Creek State Park Friday afternoon. Nothing was going to stop Leonard Sawyer from taking his boat out to do a little fishing.

4 months ago

Sponsored Articles

Photo courtesy of Artists of Ballet West...

Ballet West

The rising demand for ballet tickets: why they’re harder to get

Ballet West’s box office is experiencing demand they’ve never seen before, leaving many interested patrons unable to secure tickets they want.

Electrician repairing ceiling fan with lamps indoors...

Lighting Design

Stay cool this summer with ceiling fans

When used correctly, ceiling fans help circulate cool and warm air. They can also help you save on utilities.

Side view at diverse group of children sitting in row at school classroom and using laptops...

PC Laptops

5 internet safety tips for kids

Read these tips about internet safety for kids so that your children can use this tool for learning and discovery in positive ways.

Women hold card for scanning key card to access Photocopier Security system concept...

Les Olson

Why printer security should be top of mind for your business

Connected printers have vulnerable endpoints that are an easy target for cyber thieves. Protect your business with these tips.

Modern chandelier hanging from a white slanted ceiling with windows in the backgruond...

Lighting Design

Light up your home with these top lighting trends for 2024

Check out the latest lighting design trends for 2024 and tips on how you can incorporate them into your home.

Technician woman fixing hardware of desktop computer. Close up....

PC Laptops

Tips for hassle-free computer repairs

Experiencing a glitch in your computer can be frustrating, but with these tips you can have your computer repaired without the stress.

More questions for J&J vaccine boosters ahead of FDA review