FDA Adds Warning About Rare Reaction to J&J COVID-19 Vaccine

By MATTHEW PERRONE and MIKE STOBBE

FILE - In this March 26, 2021, file photo a member of the Philadelphia Fire Department prepares a dose of the Johnson & Johnson COVID-19 vaccine at a vaccination site setup in Philadelphia. U.S. health officials say Johnson & Johnson’s COVID-19 vaccine may pose a “small possible risk” of a potentially dangerous neurological reaction. The Centers for Disease Control and Prevention said Monday, July 12 that it has received reports of 100 people who got the shot developing an immune system disorder that can causes muscle weakness and occasionally paralysis. (AP Photo/Matt Rourke, File)

WASHINGTON (AP) — U.S. regulators on Monday added a new warning to Johnson & Johnson’s COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction, but said it’s not entirely clear the shot caused the problem.

The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness and occasionally paralysis. Health officials described the side effect as a “small possible risk” for those getting the shot.

The action comes after the FDA and the Centers for Disease Control and Prevention reviewed reports of about 100 people developing the syndrome after receiving the one-dose vaccine. Almost all of were hospitalized and one person died, the FDA said.

Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis that typically is temporary. An estimated 3,000 to 6,000 people develop the syndrome each year, according to the CDC.

The number of cases reported in connection with J&J’s vaccine represents a tiny fraction of the nearly 13 million Americans who have received the one-dose shot. Most cases were reported in men — many 50 years old and up — and usually about two weeks after vaccination.

J&J said in a statement it has been discussing the reports with the FDA and other health regulators around the world.

The CDC said it would ask its panel of outside vaccine experts to review the issue at an upcoming meeting.

The government said the vaccines most used in the U.S., made by Pfizer and Moderna, show no risk of the disorder after more than 320 million doses have been administered.

The new warning will be included in pamphlets given to people getting the J&J shot. They should seek medical attention if they experience any symptoms, which include tingling sensations, trouble walking and double vision, the FDA said.

Vaccines historically provide broad protection with little risk but come with occasional side effects just like other drugs and medical therapies. The three COVID-19 vaccines used in the U.S. were each tested in tens of thousands of people, but even such huge studies can’t rule out extremely rare side effects.

The CDC and the FDA have been monitoring side effect reports submitted by physicians, drugmakers and patients to a federal vaccine safety database.

Guillain-Barre can be triggered by a number of infections, including flu, cytomegalovirus and Zika virus. But there have been rare cases in which people develop the disorder days or weeks after receiving certain vaccines.

J&J’s vaccine was highly anticipated because of its one-and-done formulation and easy-to-ship refrigeration. But early on, it was linked to another rare risk, of blood clots, and the company hasn’t been able to produce as much as expected because of problems at a Baltimore factory that helps make the shots.

___

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.



No comments

Thank you for reaching out to us. We are happy to receive your opinion and request. If you are need advert or sponsored post, We’re excited you’re considering advertising or sponsoring a post on our blog. Your support is what keeps us going. With the current trend, it’s very obvious content marketing is the way to go. Banner advertising and trying to get customers through Google Adwords may get you customers but it has been proven beyond doubt that Content Marketing has more lasting benefits.
We offer majorly two types of advertising:
1. Sponsored Posts: If you are really interested in publishing a sponsored post or a press release, video content, advertorial or any other kind of sponsored post, then you are at the right place.
WHAT KIND OF SPONSORED POSTS DO WE ACCEPT?
Generally, a sponsored post can be any of the following:
Press release
Advertorial
Video content
Article
Interview
This kind of post is usually written to promote you or your business. However, we do prefer posts that naturally flow with the site’s general content. This means we can also promote artists, songs, cosmetic products and things that you love of all products or services.
DURATION & BONUSES
Every sponsored article will remain live on the site as long as this website exists. The duration is indefinite! Again, we will share your post on our social media channels and our email subscribers too will get to read your article. You’re exposing your article to our: Twitter followers, Facebook fans and other social networks.

We will also try as much as possible to optimize your post for search engines as well.

Submission of Materials : Sponsored post should be well written in English language and all materials must be delivered via electronic medium. All sponsored posts must be delivered via electronic version, either on disk or e-mail on Microsoft Word unless otherwise noted.
PRICING
The price largely depends on if you’re writing the content or we’re to do that. But if your are writing the content, it is $60 per article.

2. Banner Advertising: We also offer banner advertising in various sizes and of course, our prices are flexible. you may choose to for the weekly rate or simply buy your desired number of impressions.

Technical Details And Pricing
Banner Size 300 X 250 pixels : Appears on the home page and below all pages on the site.
Banner Size 728 X 90 pixels: Appears on the top right Corner of the homepage and all pages on the site.
Large rectangle Banner Size (336x280) : Appears on the home page and below all pages on the site.
Small square (200x200) : Appears on the right side of the home page and all pages on the site.
Half page (300x600) : Appears on the right side of the home page and all pages on the site.
Portrait (300x1050) : Appears on the right side of the home page and all pages on the site.
Billboard (970x250) : Appears on the home page.

Submission of Materials : Banner ads can be in jpeg, jpg and gif format. All materials must be deliverd via electronic medium. All ads must be delivered via electronic version, either on disk or e-mail in the ordered pixel dimensions unless otherwise noted.
For advertising offers, send an email with your name,company, website, country and advert or sponsored post you want to appear on our website to omodjk(at)gmail(dot)com

Normally, we should respond within 48 hours.