UNITED STATES NEWS

FDA restricts J&J’s COVID-19 vaccine due to blood clot risk

May 5, 2022, 7:00 PM | Updated: May 9, 2022, 4:22 pm
FILE - Vials of the Johnson & Johnson COVID-19 vaccine are seen at a pharmacy in Denver on Saturday...

FILE - Vials of the Johnson & Johnson COVID-19 vaccine are seen at a pharmacy in Denver on Saturday, March 6, 2021. On Thursday, May 5, 2022, U.S. regulators strictly limited who can receive this vaccine due to a rare but serious risk of blood clots. (AP Photo/David Zalubowski, File)

(AP Photo/David Zalubowski, File)

WASHINGTON (AP) — U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to the ongoing risk of rare but serious blood clots.

The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J’s vaccine. U.S. authorities for months have recommended that Americans get Pfizer or Moderna shots instead of J&J’s vaccine.

FDA’s vaccine chief Dr. Peter Marks said the agency decided to restrict the vaccine after taking another look at the data on the risks of life-threatening blood clots and concluding that they are limited to J&J’s vaccine.

“If there’s an alternative that appears to be equally effective in preventing severe outcomes from COVID-19, we’d rather see people opting for that,” Marks said. “But we’ve been careful to say that– compared to no vaccine– this is still a better option.”

The problem occurs in the first two weeks after vaccination, he added: “So if you had the vaccine six months ago you can sleep soundly tonight knowing this isn’t an issue.”

The FDA authorized J&J’s shot in February last year for adults 18 and up.

The vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective than two doses of the Pfizer and Moderna vaccines.

In December, the Centers for Disease Control and Prevention recommended Moderna and Pfizer shots over J&J’s because of its safety issues.

As of mid-March, federal scientists had identified 60 cases of the side effect, including nine that were fatal. That amounts to 3.23 blood clot cases per 1 million J&J shots. The problem is more common in women under 50, where the death rate was roughly 1 per million shots, according to Marks.

Marks said the FDA spent extra time analyzing the problem to be sure it wasn’t connected to a separate issue, such as women taking birth control medications that raise their risk of clotting.

The J&J vaccine will carry a starker warning about potential “long-term and debilitating health consequences” of the side effect.

Under the new FDA instructions, J&J’s vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can’t receive an additional dose. J&J’s shot could also be an option for people who refuse to receive the mRNA vaccines from Pfizer and Moderna, and therefore would otherwise remain unvaccinated, the agency said.

A J&J spokesman said in an emailed statement: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.”

The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. At that time, U.S. regulators decided the benefits of J&J’s one-and-done vaccine outweighed what was considered a very rare ri sk — as long as recipients were warned.

COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they’re made. Clots form in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea.

The New Brunswick, New Jersey-based company announced last month that it didn’t expect a profit from the vaccine this year and was suspending sales projections.

The rollout of the company’s vaccine was hurt by a series of troubles, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas.

Additionally, regulators added warnings about the blood clots and a rare neurological reaction called Guillain-Barré syndrome.

Pfizer and Moderna have provided the vast majority of COVID-19 vaccines in the U.S. More than 200 million Americans have been fully vaccinated with the companies’ two-dose shots while less than 17 million Americans got the J&J shot.

___

This version corrects the rate of blood clots reported with J&J’s vaccine. It is 3.23 cases per 1 million vaccinations.

___

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.

Lifetime Windows & Doors

United States News

Associated Press

Authorities: Teen sneaks loaded gun into SC holding facility

COLUMBIA, S.C. (AP) — A 13-year-old arrested for having a loaded gun at a South Carolina mall apparently sneaked a second loaded weapon into the facility where he was taken, authorities said. A Columbia Police Department spokesperson called the incident “an egregious failure on many levels,” WLTX-TV reported. It started Tuesday when the boy and […]
11 hours ago
Associated Press

Despite ample school security plan, Texas shooter found gaps

Robb Elementary School had measures in place to prevent this kind of violence. A fence lined the school property. Teachers were ordered to keep classroom doors closed and locked. Students faced regular lockdown and evacuation drills. But when an 18-year-old man arrived Tuesday at the school in Uvalde, Texas, intent on killing children, none of […]
11 hours ago
Associated Press

Alaska’s largest natural gas utility being sold for $800M

ANCHORAGE, Alaska (AP) — The owner of the largest natural gas utility in Alaska said it is selling the company to Canada-based TriSummit Utilities Inc. for $800 million. AltaGas Ltd. announced Thursday that the sale includes Anchorage-based ENSTAR Natural Gas, associated pipelines and ENSTAR’s majority ownership in a gas storage facility, the Anchorage Daily News […]
11 hours ago
Visitors mill about the exhibitors booths in the main exhibition hall at the National Rifle Associa...
Associated Press

Many back strict gun laws, but opposition tends to be louder

WASHINGTON (AP) — Majorities of U.S. adults think mass shootings would occur less often if guns were harder to get, and that schools and other public places have become less safe than they were two decades ago, polling shows. Still, public attitudes on guns and gun policy are complicated, and the issue has seen little […]
11 hours ago
Associated Press

Idaho trial for Chad and Lori Daybell delayed to January

BOISE, Idaho (AP) — A woman charged in Idaho with killing her two youngest children and her new husband’s previous wife will be tried alongside her husband and their trial has been delayed until early next year because the judge says that will give her lawyers enough time to effectively prepare a defense. Judge Steven […]
11 hours ago
In this March 23, 2021, photo, a man leaves a bouquet on a police cruiser parked outside the Boulde...
Associated Press

Mass shooters exploited gun laws, loopholes before carnage

The suspects in the shootings at a Uvalde, Texas, elementary school and a Buffalo, New York, supermarket were both just 18, authorities say, when they bought the weapons used in the attacks — too young to legally purchase alcohol or cigarettes, but old enough to arm themselves with assault weapons. The Buffalo suspect was taken […]
11 hours ago

Sponsored Articles

...
Arizona Division of Problem Gambling

Arizona Division of Problem Gambling provides exclusion solution for young sports bettors

Sports betting in Arizona opened a new world to young adults, one where putting down money on games was as easy as sending a text message.
...
Canvas Annuity

The secret to guaranteed retirement income

Annuities aren’t really a secret, but they are so misunderstood that they might as well be. Once you understand what an annuity is and how it can benefit you, you could decide this “secret” is the perfect supplement to your retirement plan.
...
Dr. Richard Carmona

Have you gotten your booster shot?

Do you remember when you got your last COVID-19 vaccination? If it has been more than five months since you completed your primary vaccination series, it’s time for you to get your booster. You may be eligible even sooner depending which vaccine you received. If you are over the age of 50 and received your […]
FDA restricts J&J’s COVID-19 vaccine due to blood clot risk